Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-08-31

Brief Summary

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Roche and GSK will carry out a meta-analysis of liver function data from trials of orlistat to establish whether there is any indication of liver toxicity. The motivation is a cumulative assessment of drug-induced liver injury (DILI) conducted by the FDA following spontaneous reports of liver toxicity in people taking Xenical or Alli.

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Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Orlistat 120

Orlistat 120mg tid

Orlistat 120

Intervention Type DRUG

Orlistat 120mg tid

Orlistat 60

Orlistat 60 mg tid

Orlistat 60

Intervention Type DRUG

Orlistat 60mg tid

Placebo

No active drug

Orlistat 120

Intervention Type DRUG

Orlistat 120mg tid

Orlistat 60

Intervention Type DRUG

Orlistat 60mg tid

Interventions

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Orlistat 120

Orlistat 120mg tid

Intervention Type DRUG

Orlistat 60

Orlistat 60mg tid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. The trial must be randomized and placebo-controlled
2. The orlistat dose must be 60mg or 120mg
3. Data on ALT or BIL must be available
4. The nominal treatment period must be 16 weeks or longer