Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases
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| ClinicalTrials.gov Identifier: NCT00001723 |
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Recruitment Status :
Completed
First Posted : November 4, 1999
Results First Posted : December 18, 2012
Last Update Posted : December 18, 2012
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Sponsor:
Jack Yanovski
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Roche Pharma AG
Information provided by (Responsible Party):
Jack Yanovski, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions |
Diabetes Mellitus Hypertension Metabolic Disease Obesity Sleep Apnea Syndrome |
| Interventions |
Drug: Orlistat Drug: Placebo |
| Enrollment | 200 |
Participant Flow
| Recruitment Details | Accrual for RCT began in 1999 and ended in 2008. All subjects were screened at the NIH Clinical Center. |
| Pre-assignment Details | Most subjects screened but not enrolled (101) did not have an obesity-related comorbid condition (i.e., hypertension or dyslipidemia). 16 met a medical exclusion, and 13 declined participation after undergoing initial evaluation. |
| Arm/Group Title | Orlistat | Placebo |
|---|---|---|
 Arm/Group Description |
Orlistat 120 mg TID for 6 months plus a behavioral weight loss program Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months. |
Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months. |
| Period Title: Overall Study | ||
| Started | 100 | 100 |
| Completed | 87 | 84 |
| Not Completed | 13 | 16 |
| Reason Not Completed | ||
| Lack of Efficacy | 6 | 7 |
| Lack of family interest | 4 | 5 |
| Lost to Follow-up | 2 | 2 |
| medication intolerance | 1 | 2 |
Baseline Characteristics
| Arm/Group Title | Orlistat | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Orlistat 120 mg TID for 6 months plus a behavioral weight loss program Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months. |
Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months. |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 100 | 100 | 200 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 100 participants | 100 participants | 200 participants | |
| <=18 years |
100 100.0%
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100 100.0%
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200 100.0%
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| Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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| >=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 100 participants | 100 participants | 200 participants | |
| 14.65 (1.38) | 14.52 (1.46) | 14.59 (1.41) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 100 participants | 100 participants | 200 participants | |
| Female |
65 65.0%
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66 66.0%
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131 65.5%
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| Male |
35 35.0%
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34 34.0%
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69 34.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 100 participants | 100 participants | 200 participants |
| 100 | 100 | 200 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Jack A. Yanovski, MD, PhD, Chief SGO, PDEGEN |
| Organization: | National Institute of Child Health and Human Development, NIH |
| Phone: | 301-496-4686 |
| EMail: | yanovskj@mail.nih.gov |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jack Yanovski, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00001723 |
| Other Study ID Numbers: |
980111 98-CH-0111 ( Other Identifier: NICHD IRB ) |
| First Submitted: | November 3, 1999 |
| First Posted: | November 4, 1999 |
| Results First Submitted: | October 11, 2012 |
| Results First Posted: | December 18, 2012 |
| Last Update Posted: | December 18, 2012 |