Text Size

Survey on the Pharmacy Follow-up of Alli Purchasers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01387243
First received: March 29, 2010
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention
Overweight
 Drug: Orlistat

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Survey on the Pharmacy Follow up of Alli Purchasers

Resource links provided by NLM:

Drug Information available for: Orlistat
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in Physical activity [ Time Frame: baseline to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in dietary behavior [ Time Frame: baseline to 1 year ] [ Designated as safety issue: No ]
  • Evaluation of care pathway (e.g., consultation with doctors, use of nutritional information) [ Time Frame: baseline to 1 year ] [ Designated as safety issue: No ]
  • Satisfaction with management (i.e., results on weight and treatment comfort) [ Time Frame: baseline to 1 year ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
60 mg Orlistat
Purchased by consumer
 Drug: Orlistat
60 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Consumers purchasing orlistat in a pharmacy setting

Criteria

Inclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387243

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01387243     History of Changes
Other Study ID Numbers: W5350856
Study First Received: March 29, 2010
Last Updated: October 25, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by GlaxoSmithKline:
behavior modification
overweight
orlistat

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Orlistat
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013