Systematically Testing the Evidence on Marijuana

Objectives: Primary: To evaluate the effect of rimonabant 20-mg once daily in comparison with placebo, on the quantitative progression of atherosclerosis as assessed by carotid artery intima-media thickness (CIMT) Secondary: To evaluate the safety and tolerability of the above rimonabant regimen in the study population of atherosclerosis patients.

First Posted: September 28, 2005

Condition(s): Carotid Artery Plaque, Arteriosclerosis, Obesity, Metabolic Syndrome X

Intervention(s): Rimonabant, Placebo (for Rimonabant)

Status: Terminated

Enrollment (expected or actual): 661

Allocation: Randomized

Sponsor: Sanofi

Principal Investigator:

Completion Date (primary or actual): April 2009

CT.gov Identifier: NCT00228176

The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.

First Posted: July 27, 2005

Condition(s): Coronary Atherosclerosis

Intervention(s): Rimonabant (SR141716), Placebo

Status: Completed

Enrollment (expected or actual): 839

Allocation: Randomized

Sponsor: Sanofi

Principal Investigator:

Completion Date (primary or actual): October 2007

CT.gov Identifier: NCT00124332

Investigators planned to adopt the N-of-1 trial approach to objectively test the effectiveness of ultra-micronized PEA at an individual level in our older outpatients. 65 years old or older persons referring to the Geriatric Unit of the Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico of Milan complaining of noncancer chronic pain of any origin will be eligible. Each trial will be a placebo-controlled randomized crossover trial including two um-PEA (600 mg twice a day) and placebo treatment pairs. Investigators will secondarily meta-analyse the performed N-of-1 trials to obtain an estimate of the average effect of um-PEA compared with placebo using a frequentist and Bayesian approach.

First Posted: March 4, 2016

Condition(s): Chronic Pain

Intervention(s): ultra-micronized palmitoylethanolamide, Placebo

Status: Completed

Enrollment (expected or actual): 11

Allocation: Randomized

Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Principal Investigator: Maura Marcucci, MD, MSc

Completion Date (primary or actual): July 2016

CT.gov Identifier: NCT02699281

Amyotrophic lateral sclerosis (ALS) is a fatal disease leading to motor neuron degeneration and progressive paralysis. Other studies have revealed defects in skeletal muscle even in absence of motor neuron anomalies, focusing on acetylcholine receptors (AChRs) and supporting the so-called "dying-back" hypothesis. Outcome of this study will be to understand if the endocannabinoid palmitoylethanolamide (PEA) can reduce the rundown of AChRs currents in ALS muscle, and if it can modify ALS patients' clinical and electrophysiological parameters.

First Posted: January 1, 2016

Condition(s): Amyotrophic Lateral Sclerosis

Intervention(s): endocannabinoid palmitoylethanolamide (PEA), Riluzole

Status: Completed

Enrollment (expected or actual): 50

Allocation: Randomized

Sponsor: University of Roma La Sapienza

Principal Investigator: Maurizio Inghilleri, Associated Professor of Neurology

Completion Date (primary or actual): June 2015

CT.gov Identifier: NCT02645461

To assess the effects of weight loss and weight maintenance over a period of two years when prescribed with a hypocaloric diet in obese patients with or without comorbidities

First Posted: January 24, 2002

Condition(s): Obesity, Weight Loss

Intervention(s): Rimonabant (SR141716)

Status: Completed

Enrollment (expected or actual): 3045

Allocation: Randomized

Sponsor: Sanofi

Principal Investigator:

Completion Date (primary or actual): April 2004

CT.gov Identifier: NCT00029861

To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes

First Posted: January 24, 2002

Condition(s): Obesity, Diabetes Mellitus, Non-Insulin-Dependent, Obesity in Diabetes

Intervention(s): Rimonabant (SR141716)

Status: Completed

Enrollment (expected or actual): 1045

Allocation: Randomized

Sponsor: Sanofi

Principal Investigator:

Completion Date (primary or actual): May 2004

CT.gov Identifier: NCT00029848

To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with untreated dyslipidemia

First Posted: January 24, 2002

Condition(s): Obesity, Dyslipidemia

Intervention(s): Rimonabant (SR141716)

Status: Completed

Enrollment (expected or actual): 1033

Allocation: Randomized

Sponsor: Sanofi

Principal Investigator:

Completion Date (primary or actual): November 2003

CT.gov Identifier: NCT00029835

One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully understood. The detection of mast cells in the endometriosis lesions supports the hypothesis that mast cell degranulation may contribute to development of pain and hyperalgesia. N-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation and pain, controlling mast-cell activation. The aim of the study is to investigate the efficacy of palmitoylethanolamide-polydatin combination on pain relief in symptomatic patients with endometriosis.

First Posted: February 26, 2015

Condition(s): Endometriosis, Chronic Pelvic Pain

Intervention(s): Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin

Status: Completed

Enrollment (expected or actual): 30

Allocation: N/A

Sponsor: University of Cagliari

Principal Investigator: Stefano Angioni, Associate Professor

Completion Date (primary or actual): August 2015

CT.gov Identifier: NCT02372903

The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months. The secondary objective is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months. Another objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.

First Posted: September 18, 2008

Condition(s): Diabetes Mellitus, Type 2

Intervention(s): Rimonabant, Metformin, placebo

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation: Randomized

Sponsor: Sanofi

Principal Investigator:

Completion Date (primary or actual): November 2008

CT.gov Identifier: NCT00754689

The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes. Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.

First Posted: June 4, 2008

Condition(s): Diabetes Mellitus, Type 2

Intervention(s): Rimonabant, Placebo (for Rimonabant), Metformin

Status: Terminated

Enrollment (expected or actual): 403

Allocation: Randomized

Sponsor: Sanofi

Principal Investigator:

Completion Date (primary or actual): February 2009

CT.gov Identifier: NCT00690456

Assessment of needs of moisturizers after various laser treatments

First Posted: December 5, 2012

Condition(s): Dermatologic Disorders, Injury Due to Laser

Intervention(s): Physiogel, Moisturizer

Status: Completed

Enrollment (expected or actual): 20

Allocation: N/A

Sponsor: Pusan National University Hospital

Principal Investigator:

Completion Date (primary or actual): April 2015

CT.gov Identifier: NCT01742247

Postsurgical pain becomes chronic when it lasts more then two months after surgery. A neurogenic or neuropathic pathogenesis is hypothesized for this event that reaches high rates after urologic and gynecologic surgeries. Palmitoylethanolamide (PEA) binds to mast cells and regulates pro-inflammatory factors release, without adverse events. The investigators assume that perioperative administration of PEA can reduce chronic postsurgical pain incidence of patients undergoing to urologic and gynecologic elective surgery.

First Posted: December 13, 2011

Condition(s): Chronic Post-operative Pain

Intervention(s): Palmitoylethanolamide, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 300

Allocation: Randomized

Sponsor: University of Modena and Reggio Emilia

Principal Investigator: Laura Rinaldi, Medical Doctor

Completion Date (primary or actual): July 2013

CT.gov Identifier: NCT01491191

Evaluation of an possible inhibiting effect of Rimonabant on the analgesic effect of Paracetamol in healthy volunteers

First Posted: September 10, 2008

Condition(s): Pain

Intervention(s): Rimonabant and Paracetamol and placebo

Status: Completed

Enrollment (expected or actual): 24

Allocation: Randomized

Sponsor: University Hospital, Clermont-Ferrand

Principal Investigator:

Completion Date (primary or actual): October 2008

CT.gov Identifier: NCT00750347

The incidence of cardiovascular diseases is still high and further efforts should be done in primary prevention. The main objective is to quantify the burden of subclinical atherosclerosis using non-invasive techniques,and to study the impact of this assessment and consequent treatment in the progression of atherosclerosis and in the incidence of cardiovascular diseases.

First Posted: August 14, 2008

Condition(s): Atherosclerosis, Cardiovascular Diseases

Intervention(s): Simvastatin or Atorvastatin, Enalapril, Aspirin or clopidogrel, Rimonabant

Status: Recruiting

Enrollment (expected or actual): 2948

Allocation: Randomized

Sponsor: Hospital Arnau de Vilanova

Principal Investigator:

Completion Date (primary or actual): April 2009

CT.gov Identifier: NCT00734123

The aim of the present study is to examine the atherosclerotic plaque stability using in vivo and in vitro techniques and to investigate the influence of exercise, anti-diabetic, lipid-lowering and cannabinoids receptor antagonists on atherosclerotic plaque texture in patients with cardiovascular risk and animals prone to atherosclerosis.

First Posted: March 14, 2008

Condition(s): Carotid Atherosclerosis, Stroke, Type 2 Diabetes, Metabolic Syndrome

Intervention(s): atorvastatin, rimonabant, rosiglitazone, metformin

Status: Completed

Enrollment (expected or actual): 300

Allocation: Randomized

Sponsor: Aristotle University Of Thessaloniki

Principal Investigator: Nikolaos Kadoglou, MD,PhD

Completion Date (primary or actual): December 2007

CT.gov Identifier: NCT00636766

The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of rimonabant 20 mg once daily (od) versus glimepiride od in reducing glycosylated haemoglobin (HbA1c) in overweight/obese patients with type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for at least 3 months. The main secondary objectives are to assess the effect of rimonabant in comparison with glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of rimonabant in comparison with glimepiride.

First Posted: March 20, 2007

Condition(s): Diabetes Mellitus, Type 2

Intervention(s): Rimonabant, Glimepiride, Metformin

Status: Terminated

Enrollment (expected or actual): 508

Allocation: Randomized

Sponsor: Sanofi

Principal Investigator:

Completion Date (primary or actual): November 2008

CT.gov Identifier: NCT00449605

The aim of this study is to establish and perfect the China Cognition and Aging Study (China COAST) cohort, to clarify the epidemiology, influencing factors, genetic characteristics, pathogenesis, disease characteristics and diagnosis and treatment status of dementia and its subtypes in China. It is of great significance to establish a relatively comprehensive national database of cognitive disorders, improve the clinical diagnosis and treatment level of cognitive disorders, and formulate prevention and treatment strategies for dementia. The primary aims of China COAST are as follows: To use the prospective cohort to establish a large database research platform, so as to provide comprehensive epidemiological data, clinical and neuropsychological evaluation data, biological samples, and laboratory tests and imaging data. To update the prevalence and incidence rate of dementia and its subtypes every 2-3 years, and clarify the conversion pattern from normal elderly to MCI and from MCI to dementia. To explore the known or unknown protective and risk factors of dementia and its major subtypes (AD, VaD, other dementia). To discover new pathogenic genes and susceptible genes of dementia and its major subtypes (AD and VaD), as well as new mutation sites of known pathogenic genes. To study the genetic variation, mutation and polymorphism of PSEN1, PSEN2, APP and APOE genes in dementia patients, and to understand their distribution and roles in the pathogenesis. To study the biomarkers (body fluid, genetics, imaging) with diagnostic value of MCI, AD (sporadic and familial) and VaD, to define their cut-off values, and to establish prediction models. To study the diagnostic criteria of cognitive normal, MCI, dementia and their subtypes (clinical and molecular subtypes) in the cohort, and to make psychological assessment scales with high sensitivity and specificity, and in line with the characteristics of Chinese people. To find potentially modifiable risk factors for dementia and to study the prevention and intervention effect of non-pharmacological treatment on APOE ε4 carriers, MCI and AD or other dementia patients，which included improvements in education, nutrition, health care, and lifestyle changes. This needs a long time follow-up. To explore the relationship between dementia as well as its major subtype AD and cerebral and systemetic circulatory disorders (for example, mixed dmentia), as well as potential therapeutic strategies. To carry out investigation and researches about dementia related education, improve the awareness of dementia, and strengthen the management of dementia. To investigate the level of stigma and discrimination and its influencing factors in patients with Alzheimer's disease and their caregivers.

First Posted: August 31, 2018

Condition(s): Mild Cognitive Impairment(MCI), Alzheimer Disease, Late Onset, Familial Alzheimer Disease (FAD), Vascular Dementia (VaD), Normal Control, Non-Alzheimer Degenerative Dementia

Intervention(s):

Status: Recruiting

Enrollment (expected or actual): 100000

Allocation:

Sponsor: Capital Medical University

Principal Investigator: Jianping Jia, Chief Director

Completion Date (primary or actual): January 1, 2038

CT.gov Identifier: NCT03653156

The Siyaphambili Study is a sequential multistage adaptive randomized trial (SMART) to compare the effectiveness and durability of two behavioral interventions on the HIV-1 virologic response among female sex workers (FSW) living with HIV in Durban, South Africa. The interventions are: 1) nurse-led decentralized treatment program (DTP) and 2) individualized case management (ICM). Viral suppression is defined as a viral load assessment <50 RNA copies/mL. The design will also estimate the incremental cost-effectiveness of study interventions and combinations of interventions compared with maintaining the South African standard of HIV care and treatment.

First Posted: April 17, 2018

Condition(s): HIV-1 Virologic Response

Intervention(s): DTP, ICM

Status: Completed

Enrollment (expected or actual): 1391

Allocation: Randomized

Sponsor: Johns Hopkins Bloomberg School of Public Health

Principal Investigator:

Completion Date (primary or actual): November 24, 2021

CT.gov Identifier: NCT03500172

This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema. Healthy volunteers, as well as patients with moderate to severe eczema (AD), between 2 and 40 years of age may be eligible for this study. We also wish to enroll children and adults aged 2-40 who have been diagnosed with inherited immune disorders known as HIES (hyperimmunoglobulin-E syndrome), WAS (Wiskott-Aldrich syndrome), or DOCK8 immunodeficiency because they frequently have skin problems similar to AD. Eligible participants undergo the following tests and procedures: Medical family and medication history Skin examination Blood tests (research blood as well as serum IgE, and complete blood count) Skin samples to analyze microbes. Samples are obtained by the following methods: swabbing the skin with a cotton swab; scraping (scratching) the skin gently with a blade to remove only the outermost skin layers; and, only in adults, biopsy (surgical removal) of a small skin sample less than 1/4-inch (5 mm) in diameter. Nose swabs to analyze microbes. Patients with eczema may have photographs of their skin taken to help monitor the skin rashes. Participants may be contacted periodically for follow-up studies. Patients with atopic dermatitis may have additional skin samples collected to examine changes in the skin bacteria over time and during all of the stages of eczema. In addition, patients who have a flare of their eczema are asked to undergo a skin sample collection as soon as possible.

First Posted: January 31, 2008

Condition(s): Atopic Dermatitis, Eczema, Ichthyosis Vulgaris

Intervention(s):

Status: Recruiting

Enrollment (expected or actual): 530

Allocation:

Sponsor: National Human Genome Research Institute (NHGRI)

Principal Investigator:

Completion Date (primary or actual):

CT.gov Identifier: NCT00605878

The purpose of the study is to assess the efficacy and safety of a range of doses of SCH 420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase inhibitor to treat Parkinson's disease. In this study, we will be comparing 3 doses (1 mg, 2 mg, and 5 mg taken twice a day) of preladenant with placebo (sugar pill). Following an Interim Analysis (temporary hold for new enrollment-ongoing subjects will continue on treatment) to review drug safety, a new dose group of 10 mg (taken twice a day) may be added. Approximately 160 participants will be randomized in this study in approximately 22 study centers worldwide for the first part of this study. Following the Interim Analysis, 40 new participants may be added, for a total of 200 participants. The study is double blind, which means neither you nor your study doctor will know whether you are receiving the study medication or placebo.

First Posted: December 4, 2006

Condition(s): Parkinson Disease, Movement Disorders, Central Nervous System Diseases, Neurodegenerative Diseases, Brain Diseases

Intervention(s): Preladenant, Preladenant, Preladenant, Preladenant, Placebo, L-dopa, Other Parkinson's Disease treatments

Status: Completed

Enrollment (expected or actual): 253

Allocation: Randomized

Sponsor: Merck Sharp & Dohme LLC

Principal Investigator:

Completion Date (primary or actual): October 5, 2008

CT.gov Identifier: NCT00406029