Last updated: 11/03/2018 16:21:51
Meta-analysis of orlistat laboratory data from placebo-controlled clinical trials
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Meta-analysis of orlistat laboratory data from placebo-controlled clinical trials
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Odds ratio (Orlistat120:Placebo) for subjects experiencing alanine transaminase (ALT) greater than upper limit of normal (ULN)
Timeframe: within one year of starting treatment
Odds ratio (Orlistat120:Placebo) for subjects experiencing total bilirubin (BIL) > ULN
Timeframe: within one year of starting treatment
Odds ratio (Orlistat120:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart
Timeframe: within one year of starting treatment
Odds ratio (Orlistat120:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart
Timeframe: within one year of starting treatment
Secondary outcomes:
Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN
Timeframe: within one year of starting treatment
Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN
Timeframe: within one year of starting treatment
Odds ratio (Orlistat60:Placebo) for subjects experiencing ALT > ULN for successive measurements more than two weeks apart
Timeframe: within one year of starting treatment
Odds ratio (Orlistat60:Placebo) for subjects experiencing BIL > ULN for successive measurements greater than two weeks apart
Timeframe: within one year of starting treatment
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Obesity
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2010 to August 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- 1. The trial must be randomized and placebo-controlled
- 2. The orlistat dose must be 60mg or 120mg
- 1. If cross-over trials are found, data from other than the first period will be excluded.
Inclusion and exclusion 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.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2010-01-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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