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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
  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: 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332448

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01332448     History of Changes
Other Study ID Numbers: 114237
Study First Received: April 7, 2011
Last Updated: April 7, 2011
Health Authority: United States: No Health Authority

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

Additional relevant MeSH terms:
Orlistat
Anti-Obesity Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014