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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women

Overview

Status
Completed
Phase
Phase 2
Enrollment
106 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jan 2013
Primary completion
Nov 2014
Completion
Nov 2014
First posted
20 Nov 2012 (estimated)
Last update posted
12 Sept 2018
Conditions
Overactive Bladder

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 2

    Interventional Clinical Trial in Patients in Overactive Bladder With Nocturia in Women

    NCT01729819

    Jan 2013 to Nov 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Tolterodine tartrate extended release capsulesDrug
  • Desmopressin orally disintegrating tabletsDrug
  • Placebo orally disintegrating tabletsDrug

Arms2

  • Experimental

    Combination

    Tolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets

  • Active comparator

    Tolterodine

    Tolterodine tartrate extended release capsules + Placebo orally disintegrating tablets

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Mean Number of Nocturnal Voids From Baseline

    Time frame · Baseline to 3 months of treatment

    Registry 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.

Secondary outcomes(5)
  1. Change in Mean Time to First Nocturnal Void From Baseline

    Time frame · Baseline to 3 months of treatment

    Registry 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.

  2. Change in Mean Nocturnal Urine Volume From Baseline

    Time frame · Baseline to 3 months of treatment

    Registry 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.

  3. Responder Status

    Time frame · Baseline to 3 months of treatment

    Registry 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.

  4. 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

    Registry 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.

  5. Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline

    Time frame · Baseline to 3 months of treatment

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline to 3 months of treatment

Change in Mean Number of Nocturnal Voids From Baseline

GroupValue (Voids)
Combination-1.63
Tolterodine-1.29
Secondary and other outcome results(5)
Secondary outcomeLeast squares mean· Baseline to 3 months of treatment

Change in Mean Time to First Nocturnal Void From Baseline

GroupValue (Minutes)
Combination118.19
Tolterodine100.19
Secondary outcomeLeast squares mean· Baseline to 3 months of treatment

Change in Mean Nocturnal Urine Volume From Baseline

GroupValue (mL)
Combination-156.6
Tolterodine-92.46
Secondary outcomeNumber· Baseline to 3 months of treatment

Responder Status

GroupValue (Proportion of responders)
Combination0.40
Tolterodine0.29
Secondary outcomeLeast squares mean· 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

GroupValue (Voids)
Treatment Difference (Combination-tolterodine)-0.19
Secondary outcomeLeast squares mean· Baseline to 3 months of treatment

Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline

GroupValue (Score on scale)
Combination1.76
Tolterodine1.33

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
CombinationTolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets Tolterodine tartrate extended release capsules Desmopressin orally disintegrating tablets0 / 480 / 483 / 48
TolterodineTolterodine tartrate extended release capsules + Placebo orally disintegrating tablets Tolterodine tartrate extended release capsules Placebo orally disintegrating tablets0 / 550 / 559 / 55

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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