Overactive BladderPhase 2NCT01729819
Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women
A Phase 2 study testing Tolterodine tartrate extended release capsules and Desmopressin orally disintegrating tablets in people with Overactive Bladder, run by Ferring Pharmaceuticals at 24 sites in United States.
Trial summary
The purpose of the trial is to investigate the efficacy of combining tolterodine and desmopressin compared with tolterodine monotherapy in the treatment of women with overactive bladder with nocturia in terms of reduction of nocturnal voids during 3 months of treatment Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Tolterodine tartrate extended release capsules and Desmopressin orally disintegrating tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 24 sitesUnited States
- Study dates
- Jan 2013to Nov 2014
- 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 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, at least 18 years of age (at the time of written consent)
- Nocturia and overactive bladder symptoms present for ≥6 months prior to trial entry (patient-reported)
- At least 2 nocturnal voids each night as documented in 2 diary periods during the screening. A mean of at least 8 daytime voids per day over 3 days with a minimum of at least 6 daytime voids each day as documented in 2 diary periods during the screening. At least 1 urgency episode each 24 hours as documented in 2 diary periods during the screening. Each diary period consists of 3 consecutive days, with at least 14 days between each period.
Who cannot join
- Evidence of severe voiding dysfunction defined as:
- More than 10 nocturnal voids per 24 hours as documented on any of the days in both diary periods during screening.
- More than 20 daytime voids per 24 hours as documented on any of the days in both diary periods during screening.
- Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder related pain, or stone in the bladder and urethra causing symptoms
- Current or a history within 5 years of lower urologic malignancies (e.g., bladder cancer), lower urinary tract surgery, previous pelvic irradiation, or severe neurological disease affecting bladder function or muscle strength (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury, spina bifida)
- Symptoms of severe stress urinary incontinence in the opinion of the investigator
Show all 24Show fewer
- 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) or a mean volume voided per void of 350 mL or more during one or more 24-hour periods as assessed by the screening diaries
- Central or nephrogenic diabetes insipidus
- Syndrome of inappropriate antidiuretic hormone (SIADH)
- Gastric retention
- Myasthenia gravis
- Uncontrolled narrow-angle glaucoma
- Suspicion or evidence of cardiac failure
- Uncontrolled and clinically relevant (in the judgement of the investigator) hypertension or diabetes mellitus
- History and/or current treatment of obstructive sleep apnoea
- Hyponatraemia:Serum sodium level must not be below 135 mmol/L
- Evidence of potential renal impairment:Serum creatinine must be within normal laboratory reference intervals AND estimated glomerular filtration rate must be more than or equal to 50 mL/min
- Hepatic and/or biliary diseases: Aspartate aminotransferase and/or alanine aminotransferase 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
- Pregnancy, breastfeeding, or a plan to become pregnant during the period of the trial. Women of reproductive age must have documentation of a reliable method of contraception. All pre- and perimenopausal women 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 night-time sleep e.g., shift workers; or any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, illiteracy or language barrier which, in the judgement of the investigator, would impair participation in the trial
- Known or suspected hypersensitivity to any active ingredient or excipients in the investigational medicinal products used in the trial
- Previous participation in any desmopressin trial within the last 5 years
- Use of any prohibited therapy, as defined in the protocol
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
The Urological Institute of Northeastern New York
Albany, New York
Parkhurst Research Organization, LLC
Bethany, Oklahoma
Medical University of South Carolina
Charleston, South Carolina
Research Across America
Dallas, Texas
Riverside Clinical Research
Edgewater, Florida
Northshore Center for Gastroenterology
Evanston, Illinois
Advances in Health
Houston, Texas
Pioneer Research Solutions, Inc.
Houston, Texas
NEA Baptist Clinic
Jonesboro, Arkansas
Health Awareness, Inc.
Jupiter, Florida
Lynn Institute of The Ozarks
Little Rock, Arkansas
Moez Khorsandi, DO
Los Angeles, California
Urology Group of Southern California
Los Angeles, California
Coastal Carolina Research Center
Mt. Pleasant, South Carolina
Vanderbilt University Medical Center
Nashville, Tennessee
Clinical Research Associates of Tidewater
Norfolk, Virginia
Pines Clinical Research, Inc.
Pembroke Pines, Florida
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania
Premier Medical Group of the Hudson Valley, P.C.
Poughkeepsie, New York
Remedica, LLC
Rochester, Michigan
Radiant Research
San Antonio, Texas
Seattle Women's: Health, Research, Gynecology
Seattle, Washington
Clinical Research Atlanta
Stockbridge, Georgia
Palm Beach Research Center
West Palm Beach, Florida
About this study
Official title: A Multi-centre, Double-blind, Randomised Trial Investigating the Efficacy and Safety of a Combination Therapy, Desmopressin and Tolterodine, for Treatment of Overactive Bladder With Nocturia in Women
The purpose of the trial is to investigate the efficacy of combining tolterodine and desmopressin compared with tolterodine monotherapy in the treatment of women with overactive bladder with nocturia in terms of reduction of nocturnal voids during 3 months of treatment
- Conditions
- Overactive Bladder
- Being tested
- Tolterodine tartrate extended release capsules, Desmopressin orally disintegrating tablets, Placebo orally disintegrating tablets
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolterodine tartrate extended release capsulesDrug
Desmopressin orally disintegrating tabletsDrug
Placebo orally disintegrating tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Combination | Experimental | Tolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets Receives: Drug: Tolterodine tartrate extended release capsules; Drug: Desmopressin orally disintegrating tablets |
| Tolterodine | Active comparator | Tolterodine tartrate extended release capsules + Placebo orally disintegrating tablets Receives: Drug: Tolterodine tartrate extended release capsules; Drug: Placebo orally disintegrating tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Number of Nocturnal Voids From Baseline
A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary.
Measured: Baseline to 3 months of treatment
Secondary outcomes (5)
Change in Mean Time to First Nocturnal Void From Baseline
The time to first nocturnal 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 the case there is no nocturnal void. The time to first void was calculated as the average over three consecutive 24-hour periods prior to the respective visits.
Measured: Baseline to 3 months of treatment
Change in Mean Nocturnal Urine Volume From Baseline
The mean nocturnal urine volume was derived from the three-day urine volume diary. The nocturnal volume was defined as the sum of the volumes for all nocturnal voids including the volume of the first morning void within 30 min of waking up in the morning.
Measured: Baseline to 3 months of treatment
Responder Status
Responder status was defined as ≥33% decrease in the mean number of nocturnal void and at least one night with no voids out of the 3-day diary period.
Measured: Baseline to 3 months of treatment
Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment
A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary.
Measured: Baseline to 3 months of treatment
Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline
An electronic diary was used in the trial to document the impact on sleep quality (sleep rating scales). The sleep rating scales included three questions that ranged from 0 (poor) to 10 (good). The average of each question for each visit was summarised and the change from baseline was analysed longitudinally during the three months of treatment.
Measured: Baseline to 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2014
- Study completionNov 2014
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 Overactive BladderStudies 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729819
- Sponsor's protocol ID
- 000085
- Status last verified
- Aug 2018
- First submitted
- 15 Nov 2012
- Last updated
- 12 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Double-blind, Randomised Trial Investigating the Efficacy and Safety of a Combination Therapy, Desmopressin and Tolterodine, for Treatment of Overactive Bladder With Nocturia in Women
- ClinicalTrials.gov ID
- NCT01729819
- Acronym / sponsor ID
- 000085
- Conditions
- Overactive Bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Posted 14 Aug 2018
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 the trial is to investigate the efficacy of combining tolterodine and desmopressin compared with tolterodine monotherapy in the treatment of women with overactive bladder with nocturia in terms of reduction of nocturnal voids during 3 months of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination | Experimental | Drug: Tolterodine tartrate extended release capsules, Drug: Desmopressin orally disintegrating tabletsTolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets |
| Tolterodine | Active comparator | Drug: Tolterodine tartrate extended release capsules, Drug: Placebo orally disintegrating tabletsTolterodine tartrate extended release capsules + Placebo orally disintegrating tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent prior to performance of any trial-related activity
- Female sex, at least 18 years of age (at the time of written consent)
- Nocturia and overactive bladder symptoms present for ≥6 months prior to trial entry (patient-reported)
- At least 2 nocturnal voids each night as documented in 2 diary periods during the screening. A mean of at least 8 daytime voids per day over 3 days with a minimum of at least 6 daytime voids each day as documented in 2 diary periods during the screening. At least 1 urgency episode each 24 hours as documented in 2 diary periods during the screening. Each diary period consists of 3 consecutive days, with at least 14 days between each period.
Key exclusion criteria (24 listed)
- Evidence of severe voiding dysfunction defined as:
- More than 10 nocturnal voids per 24 hours as documented on any of the days in both diary periods during screening.
- More than 20 daytime voids per 24 hours as documented on any of the days in both diary periods during screening.
- Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder related pain, or stone in the bladder and urethra causing symptoms
- Current or a history within 5 years of lower urologic malignancies (e.g., bladder cancer), lower urinary tract surgery, previous pelvic irradiation, or severe neurological disease affecting bladder function or muscle strength (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury, spina bifida)
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 |
|---|---|---|
| Tolterodine tartrate extended release capsules | Drug | Combination, Tolterodine |
| Desmopressin orally disintegrating tablets | Drug | Combination |
| Placebo orally disintegrating tablets | Drug | Tolterodine |
Primary outcome
Change in Mean Number of Nocturnal Voids From Baseline
Time frame: Baseline to 3 months of treatment
A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary.
5 secondary outcomes
Change in Mean Time to First Nocturnal Void From Baseline
Time frame: Baseline to 3 months of treatment
Change in Mean Nocturnal Urine Volume From Baseline
Time frame: Baseline to 3 months of treatment
Responder Status
Time frame: Baseline to 3 months of treatment
Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment
Time frame: Baseline to 3 months of treatment
Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline
Time frame: Baseline to 3 months of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- 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.
Clinical Development Support study director
Ferring Pharmaceuticals
24 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 Tolterodine tartrate extended release capsules and Desmopressin orally disintegrating tablets in people with Overactive Bladder, run by Ferring Pharmaceuticals at 24 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 24 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 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
Yes. Results are posted in the registry (first posted 14 Aug 2018). 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 in Mean Number of Nocturnal Voids From Baseline (time frame: Baseline to 3 months of treatment). 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 12 Sep 2018.