ObesityPhase 4COR-WRNCT04587843
A Trial Evaluating the Effectiveness of Contrave in Patients Who Have Weight Recidivism Following Bariatric Surgery
A Phase 4 study testing Contrave 8Mg-90Mg Extended-Release Tablet in people with Obesity, run by St. Joseph's Healthcare Hamilton at 4 sites in Canada.
Trial summary
Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Contrave 8Mg-90Mg Extended-Release Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Apr 2021to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=18 years of age
- prior primary roux en-y gastric bypass (RYGB) or sleeve gastrectomy (SG) at a surgical Center of Excellence within the Ontario Bariatric Network (OBN)
- inadequate weight loss or significant weight regain based on the OBN criteria13, defined as one of the following:
- < 10% total body weight (TBW) loss at 6 months or;
- < 20% TBW loss at 12 months or;
- Weight regain of > 25% of weight loss.
- body Mass Index (BMI) of ≥ 30 Kg/m2 or ≥ 27 Kg/m2 and the presence of at least one weight related co-morbidity
- able and willing to provide signed informed consent
Who cannot join
- pregnancy, planned pregnancy in the next 18 months and or breastfeeding
- does not agree to use highly effective method of birth control if a woman of child bearing potential, for the duration of the study
- revisional bariatric procedure or duodenal switch
- simultaneous or planned use of other weight loss medication (e.g. Saxenda / Orlistat) or meal replacement products (e.g. Optifast)
- uncontrolled hypertension, severe hepatic impairment, end-stage renal disease, end stage cardiac disease
- myocardial infarction or stroke within 6 months prior to consent
Show all 20Show fewer
- renal impairment defined as eGFR < 60
- seizure disorder or a history of seizures or following conditions that may predispose subjects to risk of seizure: history of head trauma, arteriovenous malformation, central nervous system tumor or infection, or a metabolic disorder that in opinion of the investigator may contraindicate treatment with Contrave and increase risk of seizure (e.g. hypoglycemia, hyponatremia)
- lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial
- history of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders
- use of other bupropion-containing products (including, but not limited to, Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zyban), because the incidence of seizure is dose dependent
- current or prior diagnosis of bulimia or anorexia nervosa, because of a higher incidence of seizures
- chronic opioid or opiate agonist (eg, methadone) or partial agonists (eg, buprenorphine) use, or acute opiate withdrawal
- excessive use of alcohol or sedatives, addiction to cocaine or stimulants (street drugs), or withdrawal from sedatives
- patients undergoing an abrupt discontinuation of alcohol, benzodiazepines or other sedatives and antiepileptic drugs
- concomitant administration of monoamine oxidase inhibitors (MAOI). At least 14 days should elapse between discontinuation of a MAOI and initiation of treatment with Contrave
- concomitant administration of the antipsychotic thioridazine, since bupropion may inhibit thioridazine metabolism, thus causing an increase in thioridazine levels and a potential increased risk of thioridazine-related serious ventricular arrythmias and sudden death
- known hypersensitivity (or known allergic reaction) to the investigational product(s) or any of its ingredients including lactose
- current participation in another interventional clinical trial
- not able to complete subject reported, self administered questionnaires or cannot fully understand all instructions in English
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Guelph General Hospital
Guelph, Ontario, N1E 4J4
St Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 3K7
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Humber River Hospital
North York, Ontario, M3M 0B2
About this study
Official title: A Randomized Controlled Trial Evaluating the Effectiveness of Contrave (Naltrexone HCl and Bupropion HCl) in Patients Who Have Weight Recidivism Following Bariatric Surgery: Contrave Obesity Trials (COR) Weight Regain Study
Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. It is unknown how many or which medical treatments for weight loss, such as Contrave work in the subjects who have had bariatric surgery.
The purpose of this study is to explore the effectiveness of Contrave combined with usual care (dietary and behaviour counselling) compared to placebo with usual care, in patients who have inadequate weight loss or significant weight regain following bariatric surgery.
Read the detailed description
Obesity is associated with increased mortality and morbidity and represents a worldwide epidemic that is increasing in prevalence and remains a significant problem in Canada and a burden on our healthcare system. Maintaining long-term weight loss is the "Achilles' heel" of obesity therapy. Treatment for obesity with surgery is increasing because it has been shown to produce the best results for long-term weight loss and improving obesity related risk factors and diseases. But, these benefits are often reduced by inadequate weight loss or by weight regain in many patients after surgery.
Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. It is unknown how many or which medical treatments for weight loss, such as Contrave work in the subjects who have had bariatric surgery.
This is a 1 year, phase 4, prospective, randomized, double-blind, placebo controlled study that will be conducted across multiple Bariatric Centres of Excellence (BCoE) in Ontario. Consenting participants will be randomly assigned to receive Contrave with usual care (dietary and behaviour counselling) or placebo with usual care. All subjects will also continue to receive usual care. The study includes several follow up visits to assess safety and treatment effects, some in person and others by telephone or video conferencing. Body weight, blood pressure, heart rate, waist circumference, lab tests, and subject completed questionnaires will be collected as part of usual care or for the study. Changes in medications and any possible side effects will also be monitored during the study.
To qualify, men and women must have had prior bariatric surgery (roux en-y gastric bypass or sleeve gastrectomy) at a surgical Center of Excellence within the Ontario Bariatric Network, and have inadequate weight loss or significant weight regain, based on the following OBN criteria:
- < 10% total body weight (TBW) loss at 6 months or;
- < 20% TBW loss at 12 months or;
- Weight regain of > 25% of weight loss.
The aim of this study is to explore the effectiveness of Contrave combined with usual care (dietary and behaviour counselling) compared to placebo with usual care, in patients who have inadequate weight loss or significant weight regain following bariatric surgery.
- Conditions
- Obesity
- Being tested
- Contrave 8Mg-90Mg Extended-Release Tablet, Placebo
- Keywords
- weight recidivism, weight regain, inadequate weight loss
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrave 8Mg-90Mg Extended-Release TabletDrug
Also called naltrexone HCl/bupropion HCl
Each Contrave Extended Release Tablet contains 8Mg of naltrexone HCl and 90Mg of bupropion HCl and will be administered orally. Total daily dose is 32Mg / 360Mg.
Participants randomized to the treatment arm will be administered 4 Contrave tablets a day for 1 year (2 tablets taken twice a day).
PlaceboDrug
Also called Inactive
Placebo tablets will be administered orally. Participants randomized to the control arm will be administered 4 placebo tablets a day for 1 year (2 tablets, taken twice a day).
| Study group | Role | What they receive |
|---|---|---|
| Contrave 8mg/90mg Extended Release Tablet | Experimental | Group treated with Contrave Extended Release Tablets Receives: Drug: Contrave 8Mg-90Mg Extended-Release Tablet |
| Placebo | Placebo comparator | Group given placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in absolute weight (Kg)
To determine the weight loss effect of Contrave with usual care compared to placebo with usual care, in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Proportion of participants achieving 5 percent total weight loss
To determine the weight loss effect of Contrave with usual care compared to placebo with usual care, in a post-bariatric surgery population with weight loss failure compared to a placebo with usual care.
Measured: Baseline to 12 months
Secondary outcomes (18)
Change in Body Mass Index (BMI) (Kg/m2)
To further determine effect of Contrave compared to placebo on BMI in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Percentage total body weight loss (percentage TBWL)
To determine effect of Contrave compared to placebo on weight loss in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Proportion of participants losing at least 10 percent baseline weight at 12 months
To further determine effect of Contrave compared to placebo on body weight in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Percent change in HbA1c level
To determine the effect of Contrave compared to placebo on HbA1c levels (laboratory blood test) as a measure of diabetic control in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Change in blood pressure
To determine the effect of Contrave compared to placebo on blood pressure and hypertension in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Change in lipid profile
To determine the effect of Contrave compared to placebo on lipid profile (total cholesterol, triglycerides, high density lipoprotein (HDL), low density lipoprotein (LDL)) in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Changes in impulsivity behaviours from baseline as assessed by UPPS-P Impulsive Behaviour Scale (self administered questionnaire)
To determine the effect of Contrave compared to placebo on impulsivity behaviours, in a post-bariatric surgery population with weight loss failure. Urgency, Premeditation (lack of), Perserverance (lack of), Sensation Seeking, Positive Urgency (UPPS-P Impulsive Behaviour Scale)
Measured: Baseline to 12 months
Changes in quality of life and health economic outcomes as measured with the EQ-5D-5L self administered questionnaire
To determine the effect of Contrave compared to placebo on quality of life and health economic outcomes in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Percentage of participants who are adherent to pharmacotherapy
To determine the tolerability of Contrave compared to placebo, in a post behaviour modification program setting.
Measured: Week 0 to Week 52
Average number of days participants took investigational product (Contrave or placebo)
To determine the tolerability of Contrave compared to placebo, in a post behaviour modification program setting.
Measured: Week 0 to Week 52
Change in diabetes medication requirements
To determine the effect of Contrave compared to placebo on diabetic control in a post-bariatric surgery population with weight loss failure. If the patient is consuming diabetes medications, the diabetes medications will be documented during the study including any changes in medications, and any changes to dosing and frequency.
Measured: Baseline to 12 months
Change in hypertension (high blood pressure) medication requirements
To determine the effect of Contrave compared to placebo on blood pressure and hypertension control in a post-bariatric surgery population with weight loss failure. If the patient is consuming medications for high blood pressure (hypertension), these medications will be documented during the study including any changes in medications, and any changes to dosing and frequency.
Measured: Baseline to 12 months
Change in lipid (cholesterol) medication requirements
To determine the effect of Contrave compared to placebo on control of elevated total cholesterol, triglycerides and LDL with medication in a post-bariatric surgery population with weight loss failure. If the patient is consuming medications for elevated lipids (cholesterol, triglycerides LDL), these medications will be documented during the study including any changes in medications, and any changes to dosing and frequency.
Measured: Baseline to 12 months
Changes in eating behaviours from baseline as assessed by Eating Disorder Examination Questionnaire (EDE-Q 6.0) (self administered questionnaire)
To determine the effect of Contrave compared to placebo on eating behaviours, in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Changes in eating behaviours from baseline as assessed by Yale Food Addiction Scale (YFAS) (self administered questionnaire)
To determine the effect of Contrave compared to placebo on eating behaviours, in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Changes in food cravings from baseline as assessed by Favourite Food Craving Scale (FFCS) (self administered questionnaire)
To determine the effect of Contrave compared to placebo on food cravings, in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Changes in depression from baseline as assessed by Patient Health Questionnaire 9 (PHQ-9) (self administered questionnaire)
To determine the effect of Contrave compared to placebo on depression and depressive problems, in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Changes in risk of suicidality from baseline as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
To determine the effect of Contrave compared to placebo on risk of suicidality, in a post-bariatric surgery population with weight loss failure.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Apr 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, randomized, double blind, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Principal investigator, Tony Chetty, St. Joseph's Healthcare Hamilton
- Investigators
- Aristithes G Doumouras, MD, Principal investigator, St Joseph's Healthcare Hamilton / McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587843
- Sponsor's protocol ID
- COR Weight Regain Study
- Acronym
- COR-WR
- Status last verified
- Aug 2023
- First submitted
- 5 Oct 2020
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Effectiveness of Contrave (Naltrexone HCl and Bupropion HCl) in Patients Who Have Weight Recidivism Following Bariatric Surgery: Contrave Obesity Trials (COR) Weight Regain Study
- ClinicalTrials.gov ID
- NCT04587843
- Acronym / sponsor ID
- COR-WR / COR Weight Regain Study
- Conditions
- Obesity
- Keywords
- weight recidivism, weight regain, inadequate weight loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. It is unknown how many or which medical treatments for weight loss, such as Contrave work in the subjects who have had bariatric surgery.
The purpose of this study is to explore the effectiveness of Contrave combined with usual care (dietary and behaviour counselling) compared to placebo with usual care, in patients who have inadequate weight loss or significant weight regain following bariatric surgery.
Detailed description
Obesity is associated with increased mortality and morbidity and represents a worldwide epidemic that is increasing in prevalence and remains a significant problem in Canada and a burden on our healthcare system. Maintaining long-term weight loss is the "Achilles' heel" of obesity therapy. Treatment for obesity with surgery is increasing because it has been shown to produce the best results for long-term weight loss and improving obesity related risk factors and diseases. But, these benefits are often reduced by inadequate weight loss or by weight regain in many patients after surgery.
Contrave (naltrexone HCl and bupropion HCl) extended-release tablet is an approved drug and indicated to be used with a low calorie diet and increased physical activity for chronic weight management in obese adults (BMI 30 Kg/m2 or greater) or overweight adults (BMI 27 Kg/m2 or greater) with at least one weight related condition such as hypertension or diabetes. It is unknown how many or which medical treatments for weight loss, such as Contrave work in the subjects who have had bariatric surgery.
This is a 1 year, phase 4, prospective, randomized, double-blind, placebo controlled study that will be conducted across multiple Bariatric Centres of Excellence (BCoE) in Ontario. Consenting participants will be randomly assigned to receive Contrave with usual care (dietary and behaviour counselling) or placebo with usual care. All subjects will also continue to receive usual care. The study includes several follow up visits to assess safety and treatment effects, some in person and others by telephone or video conferencing. Body weight, blood pressure, heart rate, waist circumference, lab tests, and subject completed questionnaires will be collected as part of usual care or for the study. Changes in medications and any possible side effects will also be monitored during the study.
To qualify, men and women must have had prior bariatric surgery (roux en-y gastric bypass or sleeve gastrectomy) at a surgical Center of Excellence within the Ontario Bariatric Network, and have inadequate weight loss or significant weight regain, based on the following OBN criteria:
- < 10% total body weight (TBW) loss at 6 months or;
- < 20% TBW loss at 12 months or;
- Weight regain of > 25% of weight loss.
The aim of this study is to explore the effectiveness of Contrave combined with usual care (dietary and behaviour counselling) compared to placebo with usual care, in patients who have inadequate weight loss or significant weight regain following bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel, randomized, double blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Contrave 8mg/90mg Extended Release Tablet | Experimental | Drug: Contrave 8Mg-90Mg Extended-Release TabletGroup treated with Contrave Extended Release Tablets |
| Placebo | Placebo comparator | Drug: PlaceboGroup given placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- >=18 years of age
- prior primary roux en-y gastric bypass (RYGB) or sleeve gastrectomy (SG) at a surgical Center of Excellence within the Ontario Bariatric Network (OBN)
- inadequate weight loss or significant weight regain based on the OBN criteria13, defined as one of the following:
- body Mass Index (BMI) of ≥ 30 Kg/m2 or ≥ 27 Kg/m2 and the presence of at least one weight related co-morbidity
- able and willing to provide signed informed consent
Key exclusion criteria (20 listed)
- pregnancy, planned pregnancy in the next 18 months and or breastfeeding
- does not agree to use highly effective method of birth control if a woman of child bearing potential, for the duration of the study
- revisional bariatric procedure or duodenal switch
- simultaneous or planned use of other weight loss medication (e.g. Saxenda / Orlistat) or meal replacement products (e.g. Optifast)
- uncontrolled hypertension, severe hepatic impairment, end-stage renal disease, end stage cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrave 8Mg-90Mg Extended-Release TabletAlso: naltrexone HCl/bupropion HClEach Contrave Extended Release Tablet contains 8Mg of naltrexone HCl and 90Mg of bupropion HCl and will be administered orally. Total daily dose is 32Mg / 360Mg. Participants randomized to the treatment arm will be administered 4 Contrave tablets a day for 1 year (2 tablets taken twice a day). | Drug | Contrave 8mg/90mg Extended Release Tablet |
| PlaceboAlso: InactivePlacebo tablets will be administered orally. Participants randomized to the control arm will be administered 4 placebo tablets a day for 1 year (2 tablets, taken twice a day). | Drug | Placebo |
Primary outcome
Change in absolute weight (Kg)
Time frame: Baseline to 12 months
To determine the weight loss effect of Contrave with usual care compared to placebo with usual care, in a post-bariatric surgery population with weight loss failure.
Proportion of participants achieving 5 percent total weight loss
Time frame: Baseline to 12 months
To determine the weight loss effect of Contrave with usual care compared to placebo with usual care, in a post-bariatric surgery population with weight loss failure compared to a placebo with usual care.
18 secondary outcomes
Change in Body Mass Index (BMI) (Kg/m2)
Time frame: Baseline to 12 months
Percentage total body weight loss (percentage TBWL)
Time frame: Baseline to 12 months
Proportion of participants losing at least 10 percent baseline weight at 12 months
Time frame: Baseline to 12 months
Percent change in HbA1c level
Time frame: Baseline to 12 months
Change in blood pressure
Time frame: Baseline to 12 months
Change in lipid profile
Time frame: Baseline to 12 months
Changes in impulsivity behaviours from baseline as assessed by UPPS-P Impulsive Behaviour Scale (self administered questionnaire)
Time frame: Baseline to 12 months
Changes in quality of life and health economic outcomes as measured with the EQ-5D-5L self administered questionnaire
Time frame: Baseline to 12 months
Percentage of participants who are adherent to pharmacotherapy
Time frame: Week 0 to Week 52
Average number of days participants took investigational product (Contrave or placebo)
Time frame: Week 0 to Week 52
Change in diabetes medication requirements
Time frame: Baseline to 12 months
Change in hypertension (high blood pressure) medication requirements
Time frame: Baseline to 12 months
Change in lipid (cholesterol) medication requirements
Time frame: Baseline to 12 months
Changes in eating behaviours from baseline as assessed by Eating Disorder Examination Questionnaire (EDE-Q 6.0) (self administered questionnaire)
Time frame: Baseline to 12 months
Changes in eating behaviours from baseline as assessed by Yale Food Addiction Scale (YFAS) (self administered questionnaire)
Time frame: Baseline to 12 months
Changes in food cravings from baseline as assessed by Favourite Food Craving Scale (FFCS) (self administered questionnaire)
Time frame: Baseline to 12 months
Changes in depression from baseline as assessed by Patient Health Questionnaire 9 (PHQ-9) (self administered questionnaire)
Time frame: Baseline to 12 months
Changes in risk of suicidality from baseline as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aristithes G Doumouras, MD principal investigator
St Joseph's Healthcare Hamilton / McMaster University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Contrave 8Mg-90Mg Extended-Release Tablet in people with Obesity, run by St. Joseph's Healthcare Hamilton at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in absolute weight (Kg) (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.