Abdominal Contour DefectsPhase 2LIPO-102-CL-11NCT01712451
Dose-ranging Study
A Phase 2 study testing salmeterol xinafoate, fluticasone propionate and salmeterol xinafoate in people with Abdominal Contour Defects, run by Neothetics, Inc at 6 sites in United States.
Trial summary
Dose ranging study Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Contour Defects
- What is being tested?
- salmeterol xinafoate, fluticasone propionate and salmeterol xinafoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2011to Oct 2012
- Phase
- Phase 2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 - 45 years of age inclusive
- abdominal contour defect
- BMI <25 kg/msq
- Stable diet and exercise and body weight
Who cannot join
- Prior treatment of abdominal contour defects (liposuction, abdominoplasty, etc)
- Known hypersensitivity to study drugs
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Beverly Hills, California
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Plano, Texas
Study site
Raleigh, North Carolina
Study site
San Diego, California
About this study
Official title: Dose-ranging Study of the Safety and Efficacy of Fluticasone Propionate and Salmeterol Xinafoate in Healthy Patients With Abdominal Contour Defects
Dose ranging study
- Conditions
- Abdominal Contour Defects
- Being tested
- salmeterol xinafoate, fluticasone propionate, Placebo, salmeterol xinafoate
- Keywords
- adiposity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salmeterol xinafoate, fluticasone propionateDrug
Also called LIPO-102
LIPO-102
PlaceboDrug
Placebo
salmeterol xinafoateDrug
Salmeterol
| Study group | Role | What they receive |
|---|---|---|
| LIPO-102, Low | Experimental | Not described Receives: Drug: salmeterol xinafoate, fluticasone propionate |
| LIPO-102, Mid | Experimental | Not described Receives: Drug: salmeterol xinafoate, fluticasone propionate |
| LIPO-102, High | Experimental | Not described Receives: Drug: salmeterol xinafoate, fluticasone propionate |
| LIPO-102; Placebo | Experimental | Not described Receives: Drug: Placebo |
| salmeterol xinafoate | Experimental | Not described Receives: Drug: salmeterol xinafoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events
Measured: 8 weeks treatment
Change in abdominal circumference
abdominal circumference
Measured: Baseline to 9 weeks
Secondary outcomes (4)
Change in global clinician scale score
Measured: Baseline to 9 weeks
Change in global patient scale score
Measured: Baseline to 9 weeks
Change in Photonumeric scale score
Measured: Baseline to 9 weeks
Change in Patient Reported Outcome Score
Measured: Baseline to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Contour DefectsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neothetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Murray Maytom, Study director, Neothetics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712451
- Sponsor's protocol ID
- LIPO-102-CL-11
- Acronym
- LIPO-102-CL-11
- Status last verified
- Mar 2015
- First submitted
- 16 Oct 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-ranging Study of the Safety and Efficacy of Fluticasone Propionate and Salmeterol Xinafoate in Healthy Patients With Abdominal Contour Defects
- ClinicalTrials.gov ID
- NCT01712451
- Acronym / sponsor ID
- LIPO-102-CL-11 / LIPO-102-CL-11
- Conditions
- Abdominal Contour Defects
- Keywords
- adiposity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Neothetics, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 23 Oct 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.
Dose ranging study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| LIPO-102, Low | Experimental | Drug: salmeterol xinafoate, fluticasone propionate |
| LIPO-102, Mid | Experimental | Drug: salmeterol xinafoate, fluticasone propionate |
| LIPO-102, High | Experimental | Drug: salmeterol xinafoate, fluticasone propionate |
| LIPO-102; Placebo | Experimental | Drug: Placebo |
| salmeterol xinafoate | Experimental | Drug: salmeterol xinafoate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 - 45 years of age inclusive
- abdominal contour defect
- BMI <25 kg/msq
- Stable diet and exercise and body weight
Key exclusion criteria (2 listed)
- Prior treatment of abdominal contour defects (liposuction, abdominoplasty, etc)
- Known hypersensitivity to study drugs
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 |
|---|---|---|
| salmeterol xinafoate, fluticasone propionateAlso: LIPO-102LIPO-102 | Drug | LIPO-102, High, LIPO-102, Low, LIPO-102, Mid |
| PlaceboPlacebo | Drug | LIPO-102; Placebo |
| salmeterol xinafoateSalmeterol | Drug | salmeterol xinafoate |
Primary outcome
Safety
Time frame: 8 weeks treatment
physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events
Change in abdominal circumference
Time frame: Baseline to 9 weeks
abdominal circumference
4 secondary outcomes
Change in global clinician scale score
Time frame: Baseline to 9 weeks
Change in global patient scale score
Time frame: Baseline to 9 weeks
Change in Photonumeric scale score
Time frame: Baseline to 9 weeks
Change in Patient Reported Outcome Score
Time frame: Baseline to 9 weeks
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 26 Mar 2015.
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.
Murray Maytom study director
Neothetics, Inc
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing salmeterol xinafoate, fluticasone propionate and salmeterol xinafoate in people with Abdominal Contour Defects, run by Neothetics, Inc at 6 sites in United States.
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 4 inclusion and 2 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 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety (time frame: 8 weeks treatment). The study lists 2 primary outcomes in all. 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 26 Mar 2015.