MedTrace Logo

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

NCT01332448 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2017-06-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Orlistat 120

Orlistat 120mg tid

DRUG

Orlistat 60

Orlistat 60mg tid

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-08-31
Completion
2010-08-31

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01332448 on ClinicalTrials.gov