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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01729819
First received: November 15, 2012
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

The purpose of the study 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


Condition Intervention Phase
Overactive Bladder
Drug: Tolterodine tartrate extended release capsules + Placebo orally disintegrating tablets
Drug: Tolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Change in mean number of nocturnal voids from baseline [ Time Frame: during 3 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean time to first nocturnal void from baseline [ Time Frame: during 3 months of treatment ] [ Designated as safety issue: No ]
  • Change in mean nocturnal urine volume from baseline [ Time Frame: during 3 months of treatment ] [ Designated as safety issue: Yes ]
  • Responder status [ Time Frame: during 3 months of treatment ] [ Designated as safety issue: No ]
  • Change in mean number of nocturnal voids from baseline for each visit [ Time Frame: during 3 months of treatment ] [ Designated as safety issue: No ]
  • Change in the impact on sleep as measured by the sleep rating scales from baseline [ Time Frame: during 3 months of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tolterodine
Tolterodine tartrate extended release capsules + Placebo orally disintegrating tablets
Drug: Tolterodine tartrate extended release capsules + Placebo orally disintegrating tablets
Experimental: Combination
Tolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets
Drug: Tolterodine tartrate extended release capsules + Desmopressin orally disintegrating tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729819

  Show 24 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01729819     History of Changes
Other Study ID Numbers: 000085
Study First Received: November 15, 2012
Last Updated: October 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Deamino Arginine Vasopressin
Phenylpropanolamine
Tolterodine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Anti-Obesity Agents
Antidiuretic Agents
Appetite Depressants
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Coagulants
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Nasal Decongestants
Natriuretic Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2014