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| ID | Type | Description | Link |
|---|---|---|---|
| COR-II | Other Identifier | Orexigen Therapeutics, Inc. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NB32 | Experimental | Naltrexone SR 32 mg/bupropion SR 360 mg/day with ancillary therapy |
|
| Placebo | Placebo Comparator | Placebo with ancillary therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone SR 32 mg/bupropion SR 360 mg/day | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28 | Baseline, 28 weeks | |
| Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28 | Baseline, 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lovelace Scientific Resources | Phoenix | Arizona | 85016 | United States | ||
| HOPE Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23408728 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NB32 | Naltrexone SR 32 mg/bupropion SR 360 mg/day |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Ancillary therapy | Behavioral | Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling |
|
| 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). | Baseline, 56 weeks |
| Body Weight- Proportion of Subjects With ≥10% Decrease From Baseline to Week 28 | Baseline, 28 weeks |
| Change in Waist Circumference | Baseline, 28 weeks |
| Change in Fasting HDL Cholesterol Levels | Baseline, 28 weeks |
| Change in Fasting Triglycerides Levels, Using Log-transformed Data | 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 | Baseline, 28 weeks |
| Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data | Baseline, 28 weeks |
| Change in Fasting Insulin Levels, Using Log-transformed Data | Baseline, 28 weeks |
| Change in Fasting Blood Glucose Levels | Baseline, 28 weeks |
| Change in HOMA-IR Levels, Using Log-transformed Data | HOMA-IR= Homeostasis Model Assessment-Insulin Resistance | 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 | Baseline, 28 weeks |
| Change in Fasting LDL Cholesterol Levels | Baseline, 28 weeks |
| Change in Systolic Blood Pressure | Baseline, 28 weeks |
| Change in Diastolic Blood Pressure | 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. | 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). | 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). | Baseline, 28 weeks |
| Phoenix |
| Arizona |
| 85050 |
| United States |
| HealthStar Research | Hot Springs | Arkansas | 71913 | United States |
| Northern California Research | Carmichael | California | 98608 | United States |
| Sierra Medical Research | Fresno | California | 93710 | United States |
| Pharmacology Research Institute | Newport Beach | California | 92660 | United States |
| Center for Human Nutrition University of Colorado Health Sciences Center | Denver | Colorado | 80220 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| George Washington University | Washington D.C. | District of Columbia | 20037 | United States |
| Suncoast Clinical Research | Palm Harbor | Florida | 34684 | United States |
| Comprehensive NeuroScience, Inc | Atlanta | Georgia | 30328 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Northwest Indiana Center for Clinical Research | Valparaiso | Indiana | 46383 | United States |
| Trover Center for Clinical Studies | Madisonville | Kentucky | 42431 | United States |
| Nutrition and Weight Mangement Center Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Milford Emergency Associates, Inc | Milford | Massachusetts | 01757 | United States |
| Summit Research Network, Inc. | Okemos | Michigan | 48864 | United States |
| Twin Cities Clinical Research | Brooklyn Center | Minnesota | 55430 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| Radiant Research, Inc. | St Louis | Missouri | 63141 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | United States |
| Endocrinology & Diabetes Consultants | Dover | New Hampshire | 03820 | United States |
| Lovelace Scientific Resources | Albuquerque | New Mexico | 87108 | United States |
| Central New York Clinical Research | Manlius | New York | 13104 | United States |
| Comprehensive Weight Control Program | New York | New York | 10021 | United States |
| Behavioral Medical Research | Staten Island | New York | 10305 | United States |
| Metrolina Medical Research | Charlotte | North Carolina | 28209 | United States |
| Patient Priority | Cincinnati | Ohio | 45242 | United States |
| Wells Institute For Health Awareness | Kettering | Ohio | 45429 | United States |
| The Portland Clinic | Portland | Oregon | 97205 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Mountain View Clinical Research | Greer | South Carolina | 29349 | United States |
| Palmetto Medical Research | Mt. Pleasant | South Carolina | 29464 | United States |
| Clinical Research Associates, Inc. | Nashville | Tennessee | 37203 | United States |
| The Cooper Institute | Dallas | Texas | 75230 | United States |
| Summit Research Network, Inc. | Seattle | Washington | 98104 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | NB32 | Naltrexone SR 32 mg/bupropion SR 360 mg/day |
| BG001 | Placebo | Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28 | Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | percentage of body weight | Baseline, 28 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | percentage of body weight | Baseline, 56 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28 | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, 28 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, 56 weeks |
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| Secondary | Body Weight- Proportion of Subjects With ≥10% Decrease From Baseline to Week 28 | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, 28 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Waist Circumference | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | cm | Baseline, 28 weeks |
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| Secondary | Change in Fasting HDL Cholesterol Levels | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, 28 weeks |
|
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| Secondary | Change in Fasting Triglycerides Levels, Using Log-transformed Data | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline, 28 weeks |
|
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| Secondary | 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 | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 28 weeks |
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| Secondary | Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline, 28 weeks |
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| Secondary | Change in Fasting Insulin Levels, Using Log-transformed Data | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline, 28 weeks |
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| Secondary | Change in Fasting Blood Glucose Levels | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, 28 weeks |
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| Secondary | Change in HOMA-IR Levels, Using Log-transformed Data | HOMA-IR= Homeostasis Model Assessment-Insulin Resistance | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Baseline, 28 weeks |
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| Secondary | 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 | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 28 weeks |
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| Secondary | Change in Fasting LDL Cholesterol Levels | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, 28 weeks |
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| Secondary | Change in Systolic Blood Pressure | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, 28 weeks |
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| Secondary | Change in Diastolic Blood Pressure | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline, 28 weeks |
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| Secondary | 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. | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 28 weeks |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 28 weeks |
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| Secondary | 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). | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 28 weeks |
|
|
Baseline, 56 weeks
The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NB32/48 | Naltrexone SR 32 mg/bupropion SR 360 mg/day or naltrexone SR 48 mg/bupropion SR 360 mg/day 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). NB32/48 group includes all participants in the safety analysis set randomized to NB32 at baseline, regardless of re-randomization status. | 21 | 992 | 671 | 992 | ||
| EG001 | Placebo | Placebo | 7 | 492 | 244 | 492 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 9.1 |
| ||
| Palpitations | Cardiac disorders | MedDRA 9.1 |
| ||
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 |
| ||
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 9.1 |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 9.1 |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 9.1 |
| ||
| Chest pain | General disorders | MedDRA 9.1 |
| ||
| Non-cardiac chest pain | General disorders | MedDRA 9.1 |
| ||
| Cholecystitis | Hepatobiliary disorders | MedDRA 9.1 |
| ||
| Cholelithiasis | Hepatobiliary disorders | MedDRA 9.1 |
| ||
| Meningitis viral | Infections and infestations | MedDRA 9.1 |
| ||
| Staphylococcal infection | Infections and infestations | MedDRA 9.1 |
| ||
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 9.1 |
| ||
| Snake bite | Injury, poisoning and procedural complications | MedDRA 9.1 |
| ||
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 9.1 |
| ||
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.1 |
| ||
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 9.1 |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 |
| ||
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 |
| ||
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 |
| ||
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 |
| ||
| Convulsion | Nervous system disorders | MedDRA 9.1 |
| ||
| Dizziness | Nervous system disorders | MedDRA 9.1 |
| ||
| Paraesthesia | Nervous system disorders | MedDRA 9.1 |
| ||
| Anxiety | Psychiatric disorders | MedDRA 9.1 |
| ||
| Calculus ureteric | Renal and urinary disorders | MedDRA 9.1 |
| ||
| Menorrhagia | Reproductive system and breast disorders | MedDRA 9.1 |
| ||
| Ovarian mass | Reproductive system and breast disorders | MedDRA 9.1 |
| ||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 |
| ||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 |
| ||
| Knee arthroplasty | Surgical and medical procedures | MedDRA 9.1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 |
| ||
| Dry mouth | Gastrointestinal disorders | MedDRA 9.1 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 9.1 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 |
| ||
| Bronchitis | Infections and infestations | MedDRA 9.1 |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 |
| ||
| Sinusitis | Infections and infestations | MedDRA 9.1 |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.1 |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 |
| ||
| Dizziness | Nervous system disorders | MedDRA 9.1 |
| ||
| Headache | Nervous system disorders | MedDRA 9.1 |
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| Insomnia | Psychiatric disorders | MedDRA 9.1 |
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If not already published by Sponsor as part of a multi-center publication, 18 months after conclusion of the study at all study centers, PI may publish the results for PI's study center individually. Prior to such publication, PI must provide Sponsor with at least 60 days to review and comment on the proposed publication. The review period may be extended by an additional 30 days upon request. Sponsor may delay publication for up to an additional 6 month period to file for patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Head of Global Development | Orexigen Therapeutics, Inc. | (858) 875-8600 | MedInfo@Orexigen.com |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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