OverweightNCT01387243
Survey on the Pharmacy Follow-up of Alli Purchasers
An observational study of Overweight, run by GlaxoSmithKline.
Trial summary
To assess the feasibility and acceptability of genuine pharmacy follow up of people wishing to lose weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight
- What is being tested?
- Orlistat
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consumers purchasing orlistat in a pharmacy setting
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
Official title: Survey on the Pharmacy Follow up of Alli Purchasers
To assess the feasibility and acceptability of genuine pharmacy follow up of people wishing to lose weight.
- Conditions
- Overweight
- Being tested
- Orlistat
- Keywords
- behavior modification, overweight, orlistat
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrlistatDrug
60 mg
| Study group | Role | What they receive |
|---|---|---|
| 60 mg Orlistat | Purchased by consumer Receives: Drug: Orlistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical activity
Measured: baseline to 1 year
Secondary outcomes (3)
Change in dietary behavior
Measured: baseline to 1 year
Evaluation of care pathway (e.g., consultation with doctors, use of nutritional information)
Measured: baseline to 1 year
Satisfaction with management (i.e., results on weight and treatment comfort)
Measured: baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387243
- Sponsor's protocol ID
- W5350856
- Status last verified
- Oct 2012
- First submitted
- 29 Mar 2010
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on the Pharmacy Follow up of Alli Purchasers
- ClinicalTrials.gov ID
- NCT01387243
- Acronym / sponsor ID
- W5350856
- Conditions
- Overweight
- Keywords
- behavior modification, overweight, orlistat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the feasibility and acceptability of genuine pharmacy follow up of people wishing to lose weight.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 60 mg Orlistat | – | Drug: OrlistatPurchased by consumer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consumers purchasing orlistat in a pharmacy setting
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orlistat60 mg | Drug | 60 mg Orlistat |
Primary outcome
Change in Physical activity
Time frame: baseline to 1 year
3 secondary outcomes
Change in dietary behavior
Time frame: baseline to 1 year
Evaluation of care pathway (e.g., consultation with doctors, use of nutritional information)
Time frame: baseline to 1 year
Satisfaction with management (i.e., results on weight and treatment comfort)
Time frame: baseline to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical activity (time frame: baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2012.