Back to resultsInterventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tolterodine tartrate extended release capsules
Desmopressin orally disintegrating tablets
Placebo orally disintegrating tablets
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
- NEA Baptist Clinic
- Lynn Institute of The Ozarks
- Moez Khorsandi, DO
- Urology Group of Southern California
- Riverside Clinical Research
- Health Awareness, Inc.
- Pines Clinical Research, Inc.
- Palm Beach Research Center
- Clinical Research Atlanta
- Northshore Center for Gastroenterology
- Remedica, LLC
- The Urological Institute of Northeastern New York
- Premier Medical Group of the Hudson Valley, P.C.
- Parkhurst Research Organization, LLC
- Philadelphia Clinical Research, LLC
- Medical University of South Carolina
- Coastal Carolina Research Center
- Vanderbilt University Medical Center
- Research Across America
- Advances in Health
- Pioneer Research Solutions, Inc.
- Radiant Research
- Clinical Research Associates of Tidewater
- Seattle Women's: Health, Research, Gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Combination
Tolterodine
Arm Description
Tolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets
Tolterodine tartrate extended release capsules + Placebo orally disintegrating tablets
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01729819
First Posted
November 15, 2012
Last Updated
August 16, 2018
Sponsor
Ferring Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01729819
Brief Title
Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination
Arm Type
Experimental
Arm Description
Tolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets
Arm Title
Tolterodine
Arm Type
Active Comparator
Arm Description
Tolterodine tartrate extended release capsules + Placebo orally disintegrating tablets
Intervention Type
Drug
Intervention Name(s)
Tolterodine tartrate extended release capsules
Intervention Type
Drug
Intervention Name(s)
Desmopressin orally disintegrating tablets
Intervention Type
Drug
Intervention Name(s)
Placebo orally disintegrating tablets
Primary Outcome Measure Information:
Title
Change in Mean Number of Nocturnal Voids From Baseline
Description
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.
Time Frame
Baseline to 3 months of treatment
Secondary Outcome Measure Information:
Title
Change in Mean Time to First Nocturnal Void From Baseline
Description
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.
Time Frame
Baseline to 3 months of treatment
Title
Change in Mean Nocturnal Urine Volume From Baseline
Description
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.
Time Frame
Baseline to 3 months of treatment
Title
Responder Status
Description
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.
Time Frame
Baseline to 3 months of treatment
Title
Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment
Description
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.
Time Frame
Baseline to 3 months of treatment
Title
Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline
Description
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.
Time Frame
Baseline to 3 months of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
Country
United States
Facility Name
Lynn Institute of The Ozarks
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Moez Khorsandi, DO
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Urology Group of Southern California
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
Country
United States
Facility Name
Health Awareness, Inc.
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
Pines Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
Country
United States
Facility Name
Northshore Center for Gastroenterology
City
Evanston
State/Province
Illinois
Country
United States
Facility Name
Remedica, LLC
City
Rochester
State/Province
Michigan
Country
United States
Facility Name
The Urological Institute of Northeastern New York
City
Albany
State/Province
New York
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley, P.C.
City
Poughkeepsie
State/Province
New York
Country
United States
Facility Name
Parkhurst Research Organization, LLC
City
Bethany
State/Province
Oklahoma
Country
United States
Facility Name
Philadelphia Clinical Research, LLC
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Advances in Health
City
Houston
State/Province
Texas
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
Country
United States
Facility Name
Radiant Research
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Seattle Women's: Health, Research, Gynecology
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women
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