Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients
Summary
The purpose of this study is: * To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients. * To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks of therapy in reducing body weight in obese patients. * To compare clinical efficacy of two dosage patterns for Dietressa (1 tablet 6 times daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.
Timeline
- Start
- 2011-12-12
- Primary completion
- 2013-06
- Completion
- 2013-06
Outcome
Mixed primary results
registry NUMBER Dietressa 1: 49 percentage of participants NCT01535014 ↗
registry NUMBER Placebo 3: 33 percentage of participants NCT01535014 ↗
registry analysis (superiority test); Dietressa 1 vs Placebo 3; p = 0.04; Chi-squared NCT01535014 ↗
registry MEAN Dietressa 1: -4.4 (Standard Deviation 4.2) kilogram NCT01535014 ↗
registry MEAN Placebo 3: -3.0 (Standard Deviation 3.5) kilogram NCT01535014 ↗
registry analysis (superiority test); Dietressa 2 vs Placebo 4; p = 0.07; t-test, 2 sided NCT01535014 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dietressa | Unknown | — | — |