Trial · NCT00567255
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28 | Baseline, 28 weeks | |
| Primary | Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28 | Baseline, 28 weeks | |
| Secondary | Body Weight- Mean Percent Change From Baseline to Week 56 | Baseline, 56 weeks | 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). |
| Secondary | Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 56 | Baseline, 56 weeks | 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). |
| Secondary | Body Weight- Proportion of Subjects With ≥10% Decrease From Baseline to Week 28 | Baseline, 28 weeks | |
| Secondary | Change in Waist Circumference | Baseline, 28 weeks | |
| Secondary | Change in Fasting HDL Cholesterol Levels | Baseline, 28 weeks | |
| Secondary | Change in Fasting Triglycerides Levels, Using Log-transformed Data | Baseline, 28 weeks | |
| Secondary | Change in IWQOL-Lite Total Scores | Baseline, 28 weeks | 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 |
| Secondary | Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data | Baseline, 28 weeks | |
| Secondary | Change in Fasting Insulin Levels, Using Log-transformed Data | Baseline, 28 weeks | |
| Secondary | Change in Fasting Blood Glucose Levels | Baseline, 28 weeks | |
| Secondary | Change in HOMA-IR Levels, Using Log-transformed Data | Baseline, 28 weeks | HOMA-IR= Homeostasis Model Assessment-Insulin Resistance |
| Secondary | Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire | Baseline, 28 weeks | Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult |
| Secondary | Change in Fasting LDL Cholesterol Levels | Baseline, 28 weeks | |
| Secondary | Change in Systolic Blood Pressure | Baseline, 28 weeks | |
| Secondary | Change in Diastolic Blood Pressure | Baseline, 28 weeks | |
| Secondary | Change in IDS-SR Total Score | Baseline, 28 weeks | 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. |
| Secondary | Change in Food Craving Inventory Sweets Subscale Score | Baseline, 28 weeks | 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). |
| Secondary | Change in Food Craving Inventory Carbohydrates Subscale Score | Baseline, 28 weeks | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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