OverweightPhase 1NCT01550926
A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
A Phase 1 study testing 120 mg orlistat, 60 mg orlistat and orlistat experimental dose in people with Overweight, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- 120 mg orlistat, 60 mg orlistat and orlistat experimental dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Mar 2009
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 18-60 years
- Body Mass Index: 25-33
Who cannot join
- gastrointestinal disease
- organ transplant
- HIV, hepatitis B or C
- food allergies
- alcohol or other substance abuse
- smoking
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
MDS Pharma Services
Belfast, Northern Ireland, BT9 6AD
About this study
The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.
- Conditions
- Overweight
- Being tested
- 120 mg orlistat, 60 mg orlistat, orlistat experimental dose
- Keywords
- orlistat, overweight, bioequivalence
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
120 mg orlistatDrug
2 X60 mg capsule
60 mg orlistatDrug
60 mg orlistat
orlistat experimental doseDrug
experimental
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | 60 mg orlistat Receives: Drug: 60 mg orlistat |
| Arm 2 | Active comparator | 120 mg orlistat (2 X 60 mg capsules) Receives: Drug: 120 mg orlistat |
| Arm 3 | Experimental | orlistat experimental formulation Receives: Drug: orlistat experimental dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal fat excretion
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionMar 2009
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
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT01550926
- Sponsor's protocol ID
- W3680604
- Status last verified
- Apr 2012
- First submitted
- 17 Nov 2011
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
- ClinicalTrials.gov ID
- NCT01550926
- Acronym / sponsor ID
- W3680604
- Conditions
- Overweight
- Keywords
- orlistat, overweight, bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Mar 2012 (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.
The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: 60 mg orlistat60 mg orlistat |
| Arm 2 | Active comparator | Drug: 120 mg orlistat120 mg orlistat (2 X 60 mg capsules) |
| Arm 3 | Experimental | Drug: orlistat experimental doseorlistat experimental formulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age: 18-60 years
- Body Mass Index: 25-33
Key exclusion criteria (6 listed)
- gastrointestinal disease
- organ transplant
- HIV, hepatitis B or C
- food allergies
- alcohol or other substance abuse
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 |
|---|---|---|
| 120 mg orlistat2 X60 mg capsule | Drug | Arm 2 |
| 60 mg orlistat60 mg orlistat | Drug | Arm 1 |
| orlistat experimental doseexperimental | Drug | Arm 3 |
Primary outcome
Fecal fat excretion
Time frame: 9 days
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 28 Jan 2013.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 120 mg orlistat, 60 mg orlistat and orlistat experimental dose in people with Overweight, run by GlaxoSmithKline at 1 site in United Kingdom.
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 2 inclusion and 6 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 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fecal fat excretion (time frame: 9 days). 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 28 Jan 2013.