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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: Orlistat 120 (Drug); Orlistat 60 (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Time Perspective: Retrospective

Primary outcome:

Odds ratio (Orlistat120:Placebo) for subjects experiencing alanine transaminase (ALT) greater than upper limit of normal (ULN)

Odds ratio (Orlistat120:Placebo) for subjects experiencing total bilirubin (BIL) > ULN

Odds ratio (Orlistat120:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart

Odds ratio (Orlistat120:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart

Secondary outcome:

Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN

Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN

Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart

Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: February 2010
Last updated: April 7, 2011

Page last updated: August 23, 2015

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