NCT01387243

Brief Summary

To assess the feasibility and acceptability of genuine pharmacy follow up of people wishing to lose weight.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

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

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 4, 2011

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

11 months

First QC Date

March 29, 2010

Last Update Submit

October 25, 2012

Conditions

Keywords

behavior modificationoverweightorlistat

Outcome Measures

Primary Outcomes (1)

  • Change in Physical activity

    baseline to 1 year

Secondary Outcomes (3)

  • Change in dietary behavior

    baseline to 1 year

  • Evaluation of care pathway (e.g., consultation with doctors, use of nutritional information)

    baseline to 1 year

  • Satisfaction with management (i.e., results on weight and treatment comfort)

    baseline to 1 year

Study Arms (1)

60 mg Orlistat

Purchased by consumer

Drug: Orlistat

Interventions

60 mg

60 mg Orlistat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consumers purchasing orlistat in a pharmacy setting

You may qualify if:

  • Individuals who have been recognized as being eligible for treatment, who have agreed to pharmacy follow up, and have given their informed consent to take part in the survey.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2010

First Posted

July 4, 2011

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 29, 2012

Record last verified: 2012-10