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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Orlistat

Criteria

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

Exclusion Criteria:

1. If cross-over trials are found, data from other than the first period will be excluded.