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Trial record 5 of 69 for:    ORLISTAT

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

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.
 
ClinicalTrials.gov Identifier: NCT01332448
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date April 7, 2011
First Posted Date April 11, 2011
Last Update Posted Date June 2, 2017
Study Start Date February 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 7, 2011)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01332448 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 7, 2011)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials
Official Title Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Obesity
Intervention
  • Drug: Orlistat 120
    Orlistat 120mg tid
  • Drug: Orlistat 60
    Orlistat 60mg tid
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 7, 2011)
1
Original Actual Enrollment Same as current
Actual Study Completion Date August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01332448
Other Study ID Numbers 114237
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2017