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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332448
First received: April 7, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted

April 7, 2011
April 7, 2011
February 2010
August 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Odds ratio (Orlistat120:Placebo) for subjects experiencing total bilirubin (BIL) > ULN [ Time Frame: within one year of starting treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN [ Time Frame: within one year of starting treatment ] [ Designated as safety issue: No ]
  • Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN [ Time Frame: within one year of starting treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials
Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials

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.

Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

All clinical trials found by search procedure:

  1. In-house trial repositories at GSK and Roche
  2. EMBASE (which includes MEDLINE) using the terms "orlistat", "Xenical" or "Alli", with "placebo" and "clinical trial"
  3. Recently published meta-analyses found by the search will also be searched for relevant trials
Obesity
  • Drug: Orlistat 120
    Orlistat 120mg tid
  • Drug: Orlistat 60
    Orlistat 60mg tid
  • Orlistat 120
    Orlistat 120mg tid
    Intervention: Drug: Orlistat 120
  • Orlistat 60
    Orlistat 60 mg tid
    Intervention: Drug: Orlistat 60
  • Placebo
    No active drug
    Interventions:
    • Drug: Orlistat 120
    • Drug: Orlistat 60
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
August 2010
August 2010   (final data collection date for primary outcome measure)

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.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01332448
114237
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP