ObesityPhase 2NCT01235741

A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects

A Phase 2 study testing Pramlintide+Metreleptin in people with Obesity, run by AstraZeneca at 18 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Obesity
What is being tested?: Pramlintide+Metreleptin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 213 participants
Where: 18 sitesUnited States
Study dates: Jan 2011to Sep 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is obese with a BMI ≥35 to ≤45 kg/m2.
Has stable body weight (not varying by >5% within 3 months prior to study start).
Meets certain requirements with respect to concomitant medications.
Has not smoked or used nicotine-containing products for at least 12 months prior to study start.

Who cannot join

Has not been enrolled in a weight loss program within 2 months prior to study start.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Research Site
Arlington, Virginia
Research Site
Austin, Texas
Research Site
Baton Rouge, Louisiana
Research Site
Boston, Massachusetts
Research Site
Butte, Montana
Research Site
Chicago, Illinois
Research Site
Denver, Colorado
Research Site
Greenbrae, California
Research Site
Hyattsville, Maryland
Research Site
La Jolla, California
Research Site
New York, New York
Research Site
Norfolk, Virginia
Research Site
Philadelphia, Pennsylvania
Research Site
Richmond, Virginia
Research Site
Salt Lake City, Utah
Research Site
St Louis, Missouri
Research Site
Tulsa, Oklahoma
Research Site
Winter Park, Florida

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controled, Multicenter Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects Following A Low-Calorie Diet Lead-In

Following screening, eligible subjects will be enrolled into a 6-week Low Calorie Diet (LCD) lead-in period. Subjects who lose at least 2% of their body weight at the end of the 6-week LCD lead-in period will be randomized to 1 of 2 treatment arms (pramlintide+metreleptin or placebo) to begin a 16-week treatment period during which the effect on body weight of treatment with pramlintide+metreleptin will be compared to placebo. Following the 16 week blinded core treatment period, subjects will discontinue study medication for a period of 12 weeks. Following the 12 week off-drug follow-up period, subjects in both groups will initiate a 12 week open-label treatment period with Pramlintide+Metreleptin. During the 12 week off-drug and 12 week open label treatment periods, subjects will continue to participate in a Lifestyle Intervention (LSI) program.

Conditions: Obesity
Being tested: Pramlintide+Metreleptin, Placebo
Keywords: Pramlintide, Metreleptin, Obesity, Amylin, Takeda
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pramlintide+MetreleptinDrug
Group A: Subcutaneous Injection once a day (QD): Pramlintide 360 mcg+Metreleptin 5.0 mg for 1 week followed by Pramlintide 360 mcg+Metreleptin 5.0 mg twice a day (BID) for 15 weeks.
PlaceboDrug
Group B: Subcutaneous Injection-twice a day (BID): Placebo equivalent volumes to active doses.

Study groups in NCT01235741
Study group	Role	What they receive
Group A	Experimental	Pramlintide+Metreleptin Receives: Drug: Pramlintide+Metreleptin
Group B	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population
Treatment-Emergent Adverse Events are defined as those with an onset date and time on or after the first dose of randomized study medication and on or before the last dose of randomized study medication. Post-treatment Adverse Events are defined as those with an onset date after the date of last dose (imputed if not available) of randomized study medication. Participants experiencing multiple episodes of a given adverse event are counted once.
Measured: Day 1 up to Month 6 Follow-Up
Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population
Participants who received metreleptin were analyzed; no placebo treated participants were analyzed. Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Leptin was measured in nanograms per milliliter (ng/mL).
Measured: Baseline to Month 6 Follow Up
Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population
Anti-leptin antibodies measured at Weeks 1 and 2 of drug treatment, early termination visit, and at Months 2, 4, and 6 post treatment follow-up in participants who received metreleptin.
Measured: Week 1 to Month 6 Follow-Up
Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin
In vitro assays were conducted to determine if neutralizing activity to metreleptin developed in participants treated with at least one dose of the drug during the study. Baseline is Day 1 of the Randomization Period, prior to administration of metreleptin.
Measured: Baseline to Month 6 Follow-Up
Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population
Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large.
Measured: Screening to 6 Month Follow-Up
Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population
Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L; bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL.
Measured: Screening to Month 6 Follow-Up
Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population
Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow-up was up to 6 months post treatment. Blood pressure included systolic and diastolic pressures measured in millimeters of mercury (mmHg).
Measured: Baseline to Month 6 Follow-Up
Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population
Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Heart rate was measured in beats per minute (beats/min).
Measured: Baseline up to Month 6 Follow-Up
Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population
Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Fasting glucose measured in milligrams per deciliter (mg/dL).
Measured: Baseline to 6 Month Follow-Up
Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population
Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Insulin measured in milliunits per liter (mU/L).
Measured: Baseline up to Month 6 Follow-Up
Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population
Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Lipids measured included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides. Lipids were measured in milligrams per deciliter (mg/dL).
Measured: Baseline up to Month 6 Follow-Up

Secondary outcomes (1)

Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population
Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication.
Measured: Baseline up to Month 6 Follow-Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Sep 2011

First posted8 Nov 2010 (estimated)
Study startJan 2011
Primary completionSep 2011
Study completionSep 2011

Why it stopped: Results from previous study DFA102 demonstrated neutralizing activity to metreleptin in invitro assay in 2 participants.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01235741
Sponsor's protocol ID: DFA104
Status last verified: Mar 2015
First submitted: 2 Nov 2010
Last updated: 15 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controled, Multicenter Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects Following A Low-Calorie Diet Lead-In
ClinicalTrials.gov ID: NCT01235741
Acronym / sponsor ID: DFA104
Conditions: Obesity
Keywords: Pramlintide, Metreleptin, Obesity, Amylin, Takeda
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Results from previous study DFA102 demonstrated neutralizing activity to metreleptin in invitro assay in 2 participants.
Enrolment: 213 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Takeda Pharmaceuticals North America, Inc.
Study start: Jan 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 8 Nov 2010 (estimated)
Results: Posted 9 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Drug: Pramlintide+MetreleptinPramlintide+Metreleptin
Group B	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Is obese with a BMI ≥35 to ≤45 kg/m2.
Has stable body weight (not varying by >5% within 3 months prior to study start).
Meets certain requirements with respect to concomitant medications.
Has not smoked or used nicotine-containing products for at least 12 months prior to study start.

Key exclusion criteria (1 listed)

Has not been enrolled in a weight loss program within 2 months prior to study start.

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
Pramlintide+MetreleptinGroup A: Subcutaneous Injection once a day (QD): Pramlintide 360 mcg+Metreleptin 5.0 mg for 1 week followed by Pramlintide 360 mcg+Metreleptin 5.0 mg twice a day (BID) for 15 weeks.	Drug	Group A
PlaceboGroup B: Subcutaneous Injection-twice a day (BID): Placebo equivalent volumes to active doses.	Drug	Group B

Primary outcome

Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population
Time frame: Day 1 up to Month 6 Follow-Up
Treatment-Emergent Adverse Events are defined as those with an onset date and time on or after the first dose of randomized study medication and on or before the last dose of randomized study medication. Post-treatment Adverse Events are defined as those with an onset date after the date of last dose (imputed if not available) of randomized study medication. Participants experiencing multiple episodes of a given adverse event are counted once.
Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population
Time frame: Baseline to Month 6 Follow Up
Participants who received metreleptin were analyzed; no placebo treated participants were analyzed. Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Leptin was measured in nanograms per milliliter (ng/mL).
Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population
Time frame: Week 1 to Month 6 Follow-Up
Anti-leptin antibodies measured at Weeks 1 and 2 of drug treatment, early termination visit, and at Months 2, 4, and 6 post treatment follow-up in participants who received metreleptin.
Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin
Time frame: Baseline to Month 6 Follow-Up
In vitro assays were conducted to determine if neutralizing activity to metreleptin developed in participants treated with at least one dose of the drug during the study. Baseline is Day 1 of the Randomization Period, prior to administration of metreleptin.
Number of Participants With Hematology and Urinalysis Laboratory Values of Potential Clinical Importance - Intent to Treat Population
Time frame: Screening to 6 Month Follow-Up
Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Platelets high (H) >500,000/µL; low (L) <75,000/µL. Hematocrit males <36%, females <30%. Hemoglobin males <12 g/dL, females <10 g/dL. White blood cell count (WBC) H >18,000/µL; L <1,500/µL. Urine protein H >= 3+ or >= 500 mg/dL. Urine glucose H >= 3+ or >= 500 mg/dL. Urine ketones >= 3+ or Large.
Number of Participants With Chemistry Laboratory Value of Potential Clinical Importance - Intent to Treat Population
Time frame: Screening to Month 6 Follow-Up
Criteria for laboratory values of potential clinical importance for obese and overweight (BMI >= 25 kg/m^2) participants: Total bilirubin High (H) > 2 mg/dL; Plasma or serum glucose fasting or non-fasting H > 200 mg/dL, low (L) < 60 mg/dL; Albumin L <2.5 g/dL; Creatine kinase H > 3*Upper limit of Normal (ULN); Sodium L <130 milliequivalents per liter (mEq/L), H > 150 mEq/L; potassium L<3.0 mEq/L, H> 5.5 mEq/L; bicarbonate L<18 mEq/L, H>35 mEq/L;calcium L <8mg/dL, H> 11 mg/dL; triglycerides H> 500 mg/dL; Cholesterol L < 100 mg/dL, H > 350 mg/dL; Alkaline phosphatase H > 3*ULN; Gamma-glutamyltransferase H>3*ULN; creatinine males > 1.6 mg/dL, females > 1.4 mg/dL; alanine aminotransferase H > 3*ULN; aspartate aminotransferase H > 3*ULN; urea nitrogen H > 45 mg/dL; uric acid males > 10.0 mg/dL, females > 8.0 mg/dL; Phosphorus L < 1.0 mg/dL H > 6.0 mg/dL.
Mean Change From Baseline to Month 6 Follow-Up in Blood Pressure - Intent to Treat Population
Time frame: Baseline to Month 6 Follow-Up
Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow-up was up to 6 months post treatment. Blood pressure included systolic and diastolic pressures measured in millimeters of mercury (mmHg).
Mean Change From Baseline to Month 6 Follow-Up in Heart Rate - Intent to Treat Population
Time frame: Baseline up to Month 6 Follow-Up
Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Heart rate was measured in beats per minute (beats/min).
Mean Change From Baseline to 6 Month Follow-Up in Fasting Plasma Glucose - Intent to Treat Population
Time frame: Baseline to 6 Month Follow-Up
Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Fasting glucose measured in milligrams per deciliter (mg/dL).
Mean Change From Baseline to Month 6 Follow-Up in Insulin - Intent to Treat Population
Time frame: Baseline up to Month 6 Follow-Up
Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Insulin measured in milliunits per liter (mU/L).
Mean Change From Baseline to Month 6 Follow-Up in Lipids - Intent to Treat Population
Time frame: Baseline up to Month 6 Follow-Up
Baseline was Day 1 measurement or the last measurement taken prior to first dose of randomized study medication, if Day 1 measure was missing. Follow up was 6 months post last dose of randomized study medication. Lipids measured included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, and triglycerides. Lipids were measured in milligrams per deciliter (mg/dL).

1 secondary outcome

Percent Change From Baseline to Week 1 and From Baseline to Month 6 Follow-up in Body Weight - Intent to Treat Population
Time frame: Baseline up to Month 6 Follow-Up

Results and safety

Results posted to the registry on 9 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Calorie Diet Only	213	72
Placebo	0	0
Pramlintide + Metreleptin	0	0

Primary outcome: Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population

Time frame: Day 1 up to Month 6 Follow-Up. Number. Unit: participants

Measure	On Treatment Placebo n = 36	On Treatment Pramlintide + Metreleptin n = 36	Post Treatment Placebo Arm n = 36	Post Treatment Pramlintide + Metreleptin Arm n = 36
Value	6	13	13	16

Population analysed: The intent to treat (ITT) population received at least one dose of randomized study treatment.

Primary outcome: Change From Baseline to Week 2, and to Follow up Months 2, 4, 6 in Fasting Leptin Concentration - Intent to Treat Population

Time frame: Baseline to Month 6 Follow Up. Mean (Standard Deviation). Unit: ng/mL

Measure	Pramlintide + Metreleptin n = 36
Change from baseline to Week 2 of treatment	223.38 (512.088)
Change from baseline to Month 2 Follow up	15.46 (34.885)
Change from baseline to Month 4 Follow up	20.08 (35.732)
Month 6 Follow up	10.70 (18.913)

Population analysed: All participants who received a dose of metreleptin and provided a sample were analyzed. Number of participants analyzed for Week 2, and follow up Months 2, 4, 6 were 6, and 33, 29, 29, respectively.

Primary outcome: Number of Participants With Anti-leptin Antibodies Who Received Metreleptin - Intent to Treat Population

Time frame: Week 1 to Month 6 Follow-Up. Number. Unit: participants

Measure	Pramlintide + Metreleptin n = 36
Week 1	0
Week 2	1
Early Termination	9
Month 2 Follow-Up	15
Month 4 Follow-Up	10
Month 6 Follow-Up	8

Population analysed: All participants who received at least one dose of metreleptin and provided a sample to analyze; number analyzed (n) for Week 1, Week 2, early termination, Month 2, Month 4, Month 6 Follow-up were: n=22, 5, 35, 32, 25, 28.

Primary outcome: Number of Participants With Neutralizing Activity to Metreleptin at Early Termination or During Post Treatment Follow-Up - Intent to Treat Population Who Received Metreleptin

Time frame: Baseline to Month 6 Follow-Up. Number. Unit: participants

Measure	Pramlintide + Metreleptin n = 36
Value	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events (AEs) and Serious AEs (SAEs): onset date/ time on or after first dose of randomized study medication and on or before the last dose of randomized study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo-P + Placebo-M	0 of 36 (0%)	1 of 36 (2.8%)	Not reported
Pramlintide + Metreleptin	1 of 36 (2.8%)	14 of 36 (38.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Senior Vice President, Research & Development study director

Amylin Pharmaceuticals, LLC.

18 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 Pramlintide+Metreleptin in people with Obesity, run by AstraZeneca at 18 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 1 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: stopped early, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 9 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment Emergent Adverse Events and Number With Post Treatment Adverse Events - Intent to Treat Population (time frame: Day 1 up to Month 6 Follow-Up). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01235741.

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 15 Apr 2015.