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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 2010

Interventions

  • Drug: Orlistat 120
    • Orlistat 120mg tid
  • Drug: Orlistat 60
    • Orlistat 60mg tid

Arms, Groups and Cohorts

  • Orlistat 120
    • Orlistat 120mg tid
  • Orlistat 60
    • Orlistat 60 mg tid
  • Placebo
    • No active drug

Clinical Trial Outcome Measures

Primary Measures

  • Odds ratio (Orlistat120:Placebo) for subjects experiencing alanine transaminase (ALT) greater than upper limit of normal (ULN)
    • Time Frame: within one year of starting treatment
  • Odds ratio (Orlistat120:Placebo) for subjects experiencing total bilirubin (BIL) > ULN
    • Time Frame: within one year of starting treatment
  • Odds ratio (Orlistat120:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart
    • Time Frame: within one year of starting treatment
  • Odds ratio (Orlistat120:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart
    • Time Frame: within one year of starting treatment

Secondary Measures

  • Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN
    • Time Frame: within one year of starting treatment
  • Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN
    • Time Frame: within one year of starting treatment
  • Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart
    • Time Frame: within one year of starting treatment
  • Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart
    • Time Frame: within one year of starting treatment

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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