ObesityPhase 3NCT00567255
A Safety and Efficacy Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects
A Phase 3 study testing Naltrexone SR 32 mg/bupropion SR 360 mg/day and Ancillary therapy in people with Obesity and Overweight, run by Orexigen Therapeutics, Inc at 36 sites in United States.
Trial summary
The purpose of this study is to determine whether the combination of naltrexone SR and bupropion SR is safe and effective in the treatment of obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Naltrexone SR 32 mg/bupropion SR 360 mg/day and Ancillary therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,496 participants
- Where
- 36 sitesUnited States
- Study dates
- Dec 2007to Jun 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Female or male subjects aged 18 to 65 years (inclusive)
- Body mass index (weight [kg]/height [m²]) ≥30 and ≤45 kg/m² for subjects with uncomplicated obesity, and BMI of ≥27 and ≤45 kg/m² for subjects with obesity with controlled hypertension and/or dyslipidemia
- Normotensive (systolic ≤140 mm Hg and diastolic ≤90 mm Hg). Anti-hypertensive medications were allowed with the exception of alpha-adrenergic blockers and clonidine. Medical regimen was to be stable for at least 6 weeks prior to randomization.
- Medications for the treatment of dyslipidemia were allowed as long as the medical regimen had been stable for at least 6 weeks prior to randomization.
- Free of opioid medication for 7 days prior to randomization
- No clinically significant abnormality of serum albumin, blood urea nitrogen (BUN), creatinine, bilirubin, sodium, potassium, chloride, calcium or phosphorus
Show all 18Show fewer
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 2.5 times upper limit of normal (ULN)
- No clinically significant abnormality of hematocrit, white blood cell (WBC) count, WBC differential, or platelets
- Fasting glucose <126 mg/dL and not receiving hypoglycemic agents and fasting triglycerides level <400 mg/dL
- No clinically significant abnormality on urinalysis
- Thyroid stimulating hormone (TSH) within normal limits or normal triiodothyronine (T3), if TSH was below normal limits
- Female subjects of childbearing potential had a negative serum pregnancy test
- Negative urine drug screen (UDS)
- An IDS-SR score <2 on individual items: 5 (sadness), 6 (irritability), 7 (anxiety/tension), and 18 (suicidality) and an IDS-SR total score <30
- Female subjects of childbearing potential were non-lactating and agreed to continue to use effective contraception throughout the study and 30 days after discontinuation of study drug
- Able to comply with all required study procedures and schedule
- Able to speak and read English
- Provided written informed consent
Who cannot join
- Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome)
- Serious medical condition (including but not limited to renal or hepatic insufficiency; Class III or IV congestive heart failure, history of angina pectoris, myocardial infarction, claudication, or acute limb ischemia within the previous 6 months; lifetime history of stroke)
- History of malignancy within the previous 5 years, with exception of non-melanoma skin cancer or surgically cured cervical cancer
- Lifetime history of serious psychiatric illness, including lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, or anorexia nervosa
- Current serious psychiatric illness including severe personality disorder (e.g., borderline or antisocial), current severe major depressive disorder, recent (previous 6 months) suicide attempt, current active suicidal ideation or recent hospitalization due to psychiatric illness
- Response to the bipolar disorder questions that indicated the presence of bipolar disorder
Show all 24Show fewer
- Required medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months prior to randomization
- History of drug or alcohol abuse or dependence (with the exception of nicotine dependence) within 1 year prior to study initiation
- Type I or Type II diabetes mellitus
- Screening ECG with a corrected QT (QTc) interval (using Bazett's formula >450 millisecond (msec) [males] and >470 msec [females]) or the presence of any clinically significant cardiac abnormalities, including but not limited to patterns consistent with myocardial ischemia, electrolyte abnormalities, or atrial or ventricular dysrhythmia or significant conduction abnormalities
- Received excluded concomitant medications: any psychotropic agents (including antipsychotic, antidepressant, anxiolytic, mood stabilizer or anticonvulsant agents or agents for the treatment of attention deficit disorder) with the exception of low-dose benzodiazepine or hypnotic agents for the treatment of insomnia (up to 2 mg lorazepam/day or equivalent dose of a benzodiazepine or hypnotic agent); any anorectic or weight loss agents; any over the-counter dietary supplements or herbs with psychoactive, appetite or weight effects; alpha-adrenergic blockers; dopamine agonists; clonidine; coumadin; theophylline; cimetidine; oral corticosteroids; cholestyramine; cholestypol; Depo-Provera®; smoking cessation agents; use of opioid or opioid-like analgesics, including analgesics and antitussives
- History of surgical or device (e.g., gastric banding) intervention for obesity
- History of seizures of any etiology, or of predisposition to seizures (e.g., history of cerebrovascular accident, head trauma with ≥5 minutes loss of consciousness, concussion symptoms lasting ≥15 minutes, brain surgery, skull fracture, subdural hematoma, or febrile seizures)
- History of treatment with bupropion or naltrexone within the preceding 12 months
- History of hypersensitivity or intolerance to bupropion or naltrexone
- Initiation or discontinuation of tobacco products including inhaled tobacco (e.g., cigarettes, cigars, pipes, etc), chewing tobacco or snuff within 3 months prior to randomization or planned during study participation. Use of nicotine replacement products (e.g., nicotine gum, patch, etc) during study participation was not allowed
- Used drugs, herbs, or dietary supplements believed to significantly affect body weight or participated in a weight loss management program within one month prior to randomization
- Loss or gained >4.0 kilograms within the previous 3 months prior to randomization
- Females who were pregnant or breast-feeding or planning to become pregnant during the study period or within 30 days of discontinuing study drug
- Planned surgical procedure that could impact the conduct of the study
- Received any investigational drug or used an experimental device or procedure within the previous 30 days
- Participated in any previous clinical trial conducted by Orexigen
- Had any condition that in the opinion of the investigator made the subject unsuitable for inclusion into the study
- Investigators, study personnel, sponsor representatives and their immediate families
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108
Comprehensive NeuroScience, Inc
Atlanta, Georgia, 30328
Nutrition and Weight Mangement Center Boston Medical Center
Boston, Massachusetts, 02118
Twin Cities Clinical Research
Brooklyn Center, Minnesota, 55430
Northern California Research
Carmichael, California, 98608
Metrolina Medical Research
Charlotte, North Carolina, 28209
Patient Priority
Cincinnati, Ohio, 45242
The Cooper Institute
Dallas, Texas, 75230
Geisinger Medical Center
Danville, Pennsylvania, 17822
Center for Human Nutrition University of Colorado Health Sciences Center
Denver, Colorado, 80220
Endocrinology & Diabetes Consultants
Dover, New Hampshire, 03820
Sierra Medical Research
Fresno, California, 93710
Mountain View Clinical Research
Greer, South Carolina, 29349
HealthStar Research
Hot Springs, Arkansas, 71913
Wells Institute For Health Awareness
Kettering, Ohio, 45429
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
Trover Center for Clinical Studies
Madisonville, Kentucky, 42431
Central New York Clinical Research
Manlius, New York, 13104
Milford Emergency Associates, Inc
Milford, Massachusetts, 01757
Palmetto Medical Research
Mt. Pleasant, South Carolina, 29464
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Comprehensive Weight Control Program
New York, New York, 10021
Pharmacology Research Institute
Newport Beach, California, 92660
Summit Research Network, Inc.
Okemos, Michigan, 48864
Suncoast Clinical Research
Palm Harbor, Florida, 34684
Lovelace Scientific Resources
Phoenix, Arizona, 85016
HOPE Research Institute
Phoenix, Arizona, 85050
The Portland Clinic
Portland, Oregon, 97205
Summit Research Network, Inc.
Seattle, Washington, 98104
Mercy Health Research
St Louis, Missouri, 63141
Radiant Research, Inc.
St Louis, Missouri, 63141
Behavioral Medical Research
Staten Island, New York, 10305
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383
George Washington University
Washington D.C., District of Columbia, 20037
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
About this study
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects
The purpose of this study is to determine whether the combination of naltrexone SR and bupropion SR is safe and effective in the treatment of obesity.
Read the detailed description
Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than naltrexone alone, bupropion SR alone or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with uncomplicated obesity and in those with overweight/obesity and hypertension and/or dyslipidemia.
- Conditions
- Obesity, Overweight
- Being tested
- Naltrexone SR 32 mg/bupropion SR 360 mg/day, Placebo, Ancillary therapy
- Keywords
- Obesity
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone SR 32 mg/bupropion SR 360 mg/dayDrug
Also called NB32
PlaceboDrug
Ancillary therapyBehavioural
Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling
| Study group | Role | What they receive |
|---|---|---|
| NB32 | Experimental | Naltrexone SR 32 mg/bupropion SR 360 mg/day with ancillary therapy Receives: Drug: Naltrexone SR 32 mg/bupropion SR 360 mg/day; Behavioral: Ancillary therapy |
| Placebo | Placebo comparator | Placebo with ancillary therapy Receives: Drug: Placebo; Behavioral: Ancillary therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28
Measured: Baseline, 28 weeks
Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28
Measured: Baseline, 28 weeks
Secondary outcomes (18)
Body Weight- Mean Percent Change From Baseline to Week 56
Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).The analysis of NB32 vs. placebo at Week 56 was completed using a weighted analysis. This analysis was referred to as the weighted LOCF analysis.
Subjects treated with NB32 who were re-randomized to NB48 were not included. Subjects re-randomized to NB32 were double-weighted and subjects who were not re-randomized were single-weighted. Subjects in the placebo group were single-weighted. The double weighting analysis restored the influence of poor performers at Weeks 28 to 44 in the NB32 group without including any data from the higher dose group (NB48).
Measured: Baseline, 56 weeks
Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 56
Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).The analysis of NB32 vs. placebo at Week 56 was completed using a weighted analysis. This analysis was referred to as the weighted LOCF analysis.
Subjects treated with NB32 who were re-randomized to NB48 were not included. Subjects re-randomized to NB32 were double-weighted and subjects who were not re-randomized were single-weighted. Subjects in the placebo group were single-weighted. The double weighting analysis restored the influence of poor performers at Weeks 28 to 44 in the NB32 group without including any data from the higher dose group (NB48).
Measured: Baseline, 56 weeks
Body Weight- Proportion of Subjects With ≥10% Decrease From Baseline to Week 28
Measured: Baseline, 28 weeks
Change in Waist Circumference
Measured: Baseline, 28 weeks
Change in Fasting HDL Cholesterol Levels
Measured: Baseline, 28 weeks
Change in Fasting Triglycerides Levels, Using Log-transformed Data
Measured: Baseline, 28 weeks
Change in IWQOL-Lite Total Scores
IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment
Measured: Baseline, 28 weeks
Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data
Measured: Baseline, 28 weeks
Change in Fasting Insulin Levels, Using Log-transformed Data
Measured: Baseline, 28 weeks
Change in Fasting Blood Glucose Levels
Measured: Baseline, 28 weeks
Change in HOMA-IR Levels, Using Log-transformed Data
HOMA-IR= Homeostasis Model Assessment-Insulin Resistance
Measured: Baseline, 28 weeks
Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire
Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult
Measured: Baseline, 28 weeks
Change in Fasting LDL Cholesterol Levels
Measured: Baseline, 28 weeks
Change in Systolic Blood Pressure
Measured: Baseline, 28 weeks
Change in Diastolic Blood Pressure
Measured: Baseline, 28 weeks
Change in IDS-SR Total Score
IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.
Measured: Baseline, 28 weeks
Change in Food Craving Inventory Sweets Subscale Score
The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).
Measured: Baseline, 28 weeks
Change in Food Craving Inventory Carbohydrates Subscale Score
The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).
Measured: Baseline, 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orexigen Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567255
- Sponsor's protocol ID
- NB-303
- Other IDs
- COR-II
- Status last verified
- Nov 2014
- First submitted
- 30 Nov 2007
- Last updated
- 21 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Apovian CM, Aronne L, Rubino D, Still C, Wyatt H, Burns C, Kim D, Dunayevich E; COR-II Study Group. A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). Obesity (Silver Spring). 2013 May;21(5):935-43. doi: 10.1002/oby.20309.
PubMed 23408728
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects
- ClinicalTrials.gov ID
- NCT00567255
- Acronym / sponsor ID
- NB-303
- Conditions
- Obesity, Overweight
- Keywords
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,496 participants (actual)
- Lead sponsor
- Orexigen Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Dec 2007 (estimated)
- Results
- Posted 21 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the combination of naltrexone SR and bupropion SR is safe and effective in the treatment of obesity.
Detailed description
Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than naltrexone alone, bupropion SR alone or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with uncomplicated obesity and in those with overweight/obesity and hypertension and/or dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NB32 | Experimental | Drug: Naltrexone SR 32 mg/bupropion SR 360 mg/day, Behavioral: Ancillary therapyNaltrexone SR 32 mg/bupropion SR 360 mg/day with ancillary therapy |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Ancillary therapyPlacebo with ancillary therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Female or male subjects aged 18 to 65 years (inclusive)
- Body mass index (weight [kg]/height [m²]) ≥30 and ≤45 kg/m² for subjects with uncomplicated obesity, and BMI of ≥27 and ≤45 kg/m² for subjects with obesity with controlled hypertension and/or dyslipidemia
- Normotensive (systolic ≤140 mm Hg and diastolic ≤90 mm Hg). Anti-hypertensive medications were allowed with the exception of alpha-adrenergic blockers and clonidine. Medical regimen was to be stable for at least 6 weeks prior to randomization.
- Medications for the treatment of dyslipidemia were allowed as long as the medical regimen had been stable for at least 6 weeks prior to randomization.
- Free of opioid medication for 7 days prior to randomization
Key exclusion criteria (24 listed)
- Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome)
- Serious medical condition (including but not limited to renal or hepatic insufficiency; Class III or IV congestive heart failure, history of angina pectoris, myocardial infarction, claudication, or acute limb ischemia within the previous 6 months; lifetime history of stroke)
- History of malignancy within the previous 5 years, with exception of non-melanoma skin cancer or surgically cured cervical cancer
- Lifetime history of serious psychiatric illness, including lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, or anorexia nervosa
- Current serious psychiatric illness including severe personality disorder (e.g., borderline or antisocial), current severe major depressive disorder, recent (previous 6 months) suicide attempt, current active suicidal ideation or recent hospitalization due to psychiatric illness
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 |
|---|---|---|
| Naltrexone SR 32 mg/bupropion SR 360 mg/dayAlso: NB32 | Drug | NB32 |
| Placebo | Drug | Placebo |
| Ancillary therapyAncillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling | Behavioural | NB32, Placebo |
Primary outcome
Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28
Time frame: Baseline, 28 weeks
Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28
Time frame: Baseline, 28 weeks
18 secondary outcomes
Body Weight- Mean Percent Change From Baseline to Week 56
Time frame: Baseline, 56 weeks
Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 56
Time frame: Baseline, 56 weeks
Body Weight- Proportion of Subjects With ≥10% Decrease From Baseline to Week 28
Time frame: Baseline, 28 weeks
Change in Waist Circumference
Time frame: Baseline, 28 weeks
Change in Fasting HDL Cholesterol Levels
Time frame: Baseline, 28 weeks
Change in Fasting Triglycerides Levels, Using Log-transformed Data
Time frame: Baseline, 28 weeks
Change in IWQOL-Lite Total Scores
Time frame: Baseline, 28 weeks
Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data
Time frame: Baseline, 28 weeks
Change in Fasting Insulin Levels, Using Log-transformed Data
Time frame: Baseline, 28 weeks
Change in Fasting Blood Glucose Levels
Time frame: Baseline, 28 weeks
Change in HOMA-IR Levels, Using Log-transformed Data
Time frame: Baseline, 28 weeks
Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire
Time frame: Baseline, 28 weeks
Change in Fasting LDL Cholesterol Levels
Time frame: Baseline, 28 weeks
Change in Systolic Blood Pressure
Time frame: Baseline, 28 weeks
Change in Diastolic Blood Pressure
Time frame: Baseline, 28 weeks
Change in IDS-SR Total Score
Time frame: Baseline, 28 weeks
Change in Food Craving Inventory Sweets Subscale Score
Time frame: Baseline, 28 weeks
Change in Food Craving Inventory Carbohydrates Subscale Score
Time frame: Baseline, 28 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23408728Apovian CM, Aronne L, Rubino D, Still C, Wyatt H, Burns C, Kim D, Dunayevich E; COR-II Study Group. A randomized, phase 3 trial of naltrexone SR/bupropion SR on weight and obesity-related risk factors (COR-II). Obesity (Silver Spring). 2013 May;21(5):935-43. doi: 10.1002/oby.20309.
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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.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naltrexone SR 32 mg/bupropion SR 360 mg/day and Ancillary therapy in people with Obesity and Overweight, run by Orexigen Therapeutics, Inc at 36 sites in United States.
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 18 inclusion and 24 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: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28 (time frame: Baseline, 28 weeks). 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?
On the ClinicalTrials.gov record for NCT00567255, which also lists 1 linked publication.
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 21 Nov 2014.