NCT01550926

Brief Summary

The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
Last Updated

January 28, 2013

Status Verified

April 1, 2012

Enrollment Period

28 days

First QC Date

November 17, 2011

Last Update Submit

January 24, 2013

Conditions

Overweight

Keywords

orlistatoverweightbioequivalence

Outcome Measures

Primary Outcomes (1)

  • Fecal fat excretion

    9 days

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

60 mg orlistat

Drug: 60 mg orlistat

Arm 2

ACTIVE COMPARATOR

120 mg orlistat (2 X 60 mg capsules)

Drug: 120 mg orlistat

Arm 3

EXPERIMENTAL

orlistat experimental formulation

Drug: orlistat experimental dose

Interventions

120 mg orlistatDRUG

2 X60 mg capsule

Arm 2
60 mg orlistatDRUG

60 mg orlistat

Arm 1
orlistat experimental doseDRUG

experimental

Arm 3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age: 18-60 years
  • Body Mass Index: 25-33

You may not qualify if:

  • gastrointestinal disease
  • organ transplant
  • HIV, hepatitis B or C
  • food allergies
  • alcohol or other substance abuse
  • smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDS Pharma Services

Belfast, Northern Ireland, BT9 6AD, United Kingdom

Location

MeSH Terms

Conditions

Overweight

Interventions

Orlistat

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2011

First Posted

March 12, 2012

Study Start

February 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 28, 2013

Record last verified: 2012-04

Locations

GB(1)