NocturiaPhase 3COMFORTNCT01223937

Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients

A Phase 3 study testing Desmopressin in people with Nocturia, run by Ferring Pharmaceuticals at 45 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to investigate the safety and efficacy of desmopressin oral melt tablets against placebo during 3 months of treatment in adult females with nocturia. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Nocturia
What is being tested?: Desmopressin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 268 participants
Where: 45 sitesin 2 countries
Study dates: Nov 2010to Nov 2011
Phase: Phase 3
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent prior to performance of any trial-related activity
Female sex 18 years of age or older
At least 2 voids every night in a consecutive 3-day period during the screening period

Who cannot join

Evidence of severe daytime voiding dysfunction defined as:
Urge urinary incontinence (more than 1 episode/day in the 3-day diary period)
Urgency (more than 1 episode/day in the 3-day diary period)
Frequency (more than 8 daytime voids/day in the 3-day diary period)
Interstitial cystitis
Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention

Show all 26Show fewer

Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours)
Central or nephrogenic diabetes insipidus
Syndrome of inappropriate anti-diuretic hormone secretion
Current or a history of urologic malignancies e.g. bladder cancer
Genitourinary tract pathology e.g., infection or stone in the bladder and urethra causing symptoms
Neurogenic detrusor activity (detrusor overactivity).
Suspicion or evidence of cardiac failure
Uncontrolled hypertension
Uncontrolled diabetes mellitus
Hyponatraemia: Serum sodium level must be within normal limits
Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min
Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL
History of obstructive sleep apnea
Previous desmopressin treatment for nocturia
Treatment with another investigational product within 3 months prior to screening
Concomitant treatment with any prohibited medication e.g., loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
Pregnancy, breastfeeding, or a plan to become pregnant during the period of the clinical trial. Subjects of reproductive age must have documentation of a reliable method of contraception. All pre-and perimenopausal subjects have to perform pregnancy tests. Amenorrhea of more than 12 months' duration based on the reported date of the last menstrual period is sufficient documentation of post-menopausal status and does not require a pregnancy test
Known alcohol or substance abuse
Work or lifestyle that may interfere with regular nighttime sleep e.g., shift workers
Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the Investigator, would impair participation in the trial

Trial locations and contacts

45 sites in 2 countries.

Country

City, postcode or hospital

45 sites in 2 countries

United States41 sites

Radiant Research, Inc.
Akron, Ohio
South Florida Medical Research
Aventura, Florida
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania
Radiant Research Inc.
Chicago, Illinois
Community Research
Cincinnati, Ohio
Women's Medical Research Group, LLC
Clearwater, Florida
Southeastern Institute
Columbus, Georgia
Southeastern Medical Research Institute
Columbus, Georgia
Complete HealthCare for Women
Columbus, Ohio
Radiant Research Inc.
Dallas, Texas
Avail Clinical Research, LLC
DeLand, Florida
Downtown Woman's Health Care
Denver, Colorado
Radiant Research, Inc.
Edina, Minnesota
Anderson & Collins Clinical Research Inc
Edison, New Jersey
HWC Women's Research Center
Englewood, Ohio
NorthShore University HealthSystem
Evanston, Illinois
Family Medical Center
Foothill Ranch, California
ACCUMED Research Associates
Garden City, New York
Radiant Research, Inc.
Greer, South Carolina
Medical Affiliated Research Center Inc.
Huntsville, Alabama
FPA Clinical Research
Kissimmee, Florida
Radiant Research
Las Vegas, Nevada
Sunrise Medical Research
Lauderdale Lakes, Florida
Axis Clinical Trials
Los Angeles, California
Exemplar Research Inc.
Morgantown, West Virginia
Carolina Urologic Research Center
Myrtle Beach, South Carolina
Beyer Research
Paw Paw, Michigan
Accelovance
Peoria, Illinois
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania
DMI Research
Pinellas Park, Florida
Remedica, LLC
Rochester, Michigan
Quality Research, Inc.
San Antonio, Texas
Radiant Research, Inc.
San Antonio, Texas
Radiant Research Inc.
Santa Rosa, California
Radiant Research Inc.
Scottsdale, Arkansas
Accelovance
South Bend, Indiana
FutureCare Studies
Springfield, Massachusetts
Radiant Research, Inc.
St Louis, Missouri
Bay State Clinical Trials, Inc.
Watertown, Massachusetts
Front Range Clinical Research
Wheat Ridge, Colorado
Center for Urologic Research of WNY, LLC
Williamsville, New York

Other trials in United States

Canada4 sites

The Male/Female Health Research Center
Barrie, Ontario
Urology Associates/Urologic Medical Research
Kitchener, Ontario
Investigational site
North Bay, Ontario
CanMed Clinical Research Inc.
Victoria, British Columbia

Other trials in Canada

About this study

Official title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablet for the Treatment of Nocturia in Adult Females

Conditions: Nocturia
Being tested: Desmopressin, Placebo
Medical subject headings: Nocturia

What participants receive

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

DesmopressinDrug
Also called FE992026, MINIRIN®, Nocturin®
PlaceboDrug

Study groups in NCT01223937
Study group	Role	What they receive
Desmopressin 25 μg	Experimental	Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period. Receives: Drug: Desmopressin
Placebo	Placebo comparator	Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period. Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period
The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.
Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints.
Measured: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)
Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3
Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.
This was the second co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints.
Measured: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)

Secondary outcomes (7)

Change From Baseline in Mean Number of Nocturnal Voids at Month 3
The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Month 3 for this outcome) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.
Secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed.
Measured: Day 1 (Baseline), Month 3
Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3
Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed.
Measured: Day 1 (Baseline), Month 3
Change From Baseline in Mean Time to First Nocturnal Void at Month 3
The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in cases where there was no nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed.
Measured: Day 1 (Baseline), Month 3
Change From Baseline in Nocturnal Urine Volume at Month 3
The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed.
Measured: Day 1 (Baseline), Month 3
Change From Baseline in 24-Hour Urine Volume at Month 3
Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed.
Measured: Day 1 (Baseline), Month 3
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day of the last dose of desmopressin. An adverse drug reaction (ADR) was any AE assessed by the Investigator as possibly/probably related to study drug.
Measured: Day 1 up to 3 months
Minimum Post-Treatment Serum Sodium Levels
Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.
Measured: Day 1 up to 3 months

Timeline

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

Nov 2010Nov 2011

First posted19 Oct 2010 (estimated)
Study startNov 2010
Primary completionNov 2011
Study completionNov 2011

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for NocturiaStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 268 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01223937
Sponsor's protocol ID: FE992026 CS40
Acronym: COMFORT
Status last verified: Sep 2015
First submitted: 18 Oct 2010
Last updated: 15 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sand PK, Dmochowski RR, Reddy J, van der Meulen EA. Efficacy and safety of low dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013 Sep;190(3):958-64. doi: 10.1016/j.juro.2013.02.037. Epub 2013 Feb 20.
PubMed 23454404
Juul KV, Malmberg A, van der Meulen E, Walle JV, Norgaard JP. Low-dose desmopressin combined with serum sodium monitoring can prevent clinically significant hyponatraemia in patients treated for nocturia. BJU Int. 2017 May;119(5):776-784. doi: 10.1111/bju.13718. Epub 2016 Dec 10.
PubMed 27862898

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?

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Study at a glance

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

Official title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablet for the Treatment of Nocturia in Adult Females
ClinicalTrials.gov ID: NCT01223937
Acronym / sponsor ID: COMFORT / FE992026 CS40
Conditions: Nocturia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 268 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 19 Oct 2010 (estimated)
Results: Posted 15 Oct 2015

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
Desmopressin 25 μg	Experimental	Drug: DesmopressinParticipants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
Placebo	Placebo comparator	Drug: PlaceboParticipants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Written informed consent prior to performance of any trial-related activity
Female sex 18 years of age or older
At least 2 voids every night in a consecutive 3-day period during the screening period

Key exclusion criteria (26 listed)

Evidence of severe daytime voiding dysfunction defined as:
Interstitial cystitis
Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours)
Central or nephrogenic diabetes insipidus

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
DesmopressinAlso: FE992026, MINIRIN®, Nocturin®	Drug	Desmopressin 25 μg
Placebo	Drug	Placebo

Primary outcome

Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period
Time frame: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)
The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below. Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints.
Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3
Time frame: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)
Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. This was the second co-primary endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints.

7 secondary outcomes

Change From Baseline in Mean Number of Nocturnal Voids at Month 3
Time frame: Day 1 (Baseline), Month 3
Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3
Time frame: Day 1 (Baseline), Month 3
Change From Baseline in Mean Time to First Nocturnal Void at Month 3
Time frame: Day 1 (Baseline), Month 3
Change From Baseline in Nocturnal Urine Volume at Month 3
Time frame: Day 1 (Baseline), Month 3
Change From Baseline in 24-Hour Urine Volume at Month 3
Time frame: Day 1 (Baseline), Month 3
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 up to 3 months
Minimum Post-Treatment Serum Sodium Levels
Time frame: Day 1 up to 3 months

Results and safety

Results posted to the registry on 15 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	131	114
Desmopressin 25 μg	137	119

Primary outcome: Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period

Time frame: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period). Mean (Standard Deviation). Unit: nocturnal voids

Measure	Placebo n = 128	Desmopressin 25 μg n = 133
Week 1 (n=124, 128)	-1 (0.94)	-1.21 (0.957)
Month 1 (n=121, 126)	-1.25 (1.12)	-1.47 (1)
Month 2 (n=116, 121)	-1.36 (1.12)	-1.57 (1.03)
Month 3 (n=107, 113)	-1.38 (1.13)	-1.69 (0.978)

Placebo vs Desmopressin 25 μg: Mean Difference (Final Values): -0.22 (95% CI -0.42 to -0.02), p = 0.0280, ANCOVA

Population analysed: Full analysis set (FAS).

Primary outcome: Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3

Time frame: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period). Number. Unit: probability

Measure	Placebo n = 128	Desmopressin 25 μg n = 133
Value	0.64	0.76

Placebo vs Desmopressin 25 μg: Odds Ratio (OR): 1.85 (95% CI 1.19 to 2.86), p = 0.0061, Generalized Estimating Equation (GEE)

Population analysed: Full analysis set (FAS).

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 126 (1.6%)	14 of 126 (11.1%)	Not reported
Desmopressin 25 μg	0 of 135 (0%)	12 of 135 (8.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23454404Sand PK, Dmochowski RR, Reddy J, van der Meulen EA. Efficacy and safety of low dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013 Sep;190(3):958-64. doi: 10.1016/j.juro.2013.02.037. Epub 2013 Feb 20.
Derived from this study: PubMed 27862898Juul KV, Malmberg A, van der Meulen E, Walle JV, Norgaard JP. Low-dose desmopressin combined with serum sodium monitoring can prevent clinically significant hyponatraemia in patients treated for nocturia. BJU Int. 2017 May;119(5):776-784. doi: 10.1111/bju.13718. Epub 2016 Dec 10.

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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.

Clinical Development Support study director

Ferring Pharmaceuticals

45 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Desmopressin in people with Nocturia, run by Ferring Pharmaceuticals at 45 sites in 2 countries.

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 3 inclusion and 26 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 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 15 Oct 2015). 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?

Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period (time frame: Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)). 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?

On the ClinicalTrials.gov record for NCT01223937, which also lists 2 linked publications.

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 Oct 2015.