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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01332448
First Posted: April 11, 2011
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention
Obesity Drug: Orlistat 120 Drug: Orlistat 60

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome 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 Outcome 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 ]

Enrollment: 1
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Orlistat 120
Orlistat 120mg tid
Drug: Orlistat 120
Orlistat 120mg tid
Orlistat 60
Orlistat 60 mg tid
Drug: Orlistat 60
Orlistat 60mg tid
Placebo
No active drug
Drug: Orlistat 120
Orlistat 120mg tid
Drug: Orlistat 60
Orlistat 60mg tid

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332448


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332448     History of Changes
Other Study ID Numbers: 114237
First Submitted: April 7, 2011
First Posted: April 11, 2011
Last Update Posted: June 2, 2017
Last Verified: June 2017

Keywords provided by GlaxoSmithKline:
Xenical
Alli
safety
meta-analysis
liver-function test
Roche
orlistat

Additional relevant MeSH terms:
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents