Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness

This study has been withdrawn prior to enrollment.
(Study was cancelled due to lack of enrollment)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Cognitive Research Corporation
ClinicalTrials.gov Identifier:
NCT01018225
First received: November 20, 2009
Last updated: July 27, 2010
Last verified: July 2010
  Purpose

The purpose of this study is to evaluate the efficacy of darifenacin in the treatment of moderate to severe nocturia in patients with overactive bladder and who do not have non-urologic causes of nocturia.


Condition Intervention Phase
Nocturia
Drug: darifenacin
Drug: Placebo
Phase 4

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Cognitive Research Corporation:

Estimated Enrollment: 24
Study Start Date: November 2009
Estimated Study Completion Date: July 2010
Arms Assigned Interventions
Experimental: darifenacin Drug: darifenacin
7.5 or 15 mg darifenacin, once a day for 6 weeks
Other Name: Enablex
Placebo Comparator: Sugar Pill Drug: Placebo
Placebo pill, once a day, for six weeks

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be aged 21-70, inclusive.
  • Subject mush have given written, personally signed and dated informed consent.
  • Subject must be diagnosed with overactive bladder.
  • Subject must have a nocturia frequency of greater than or equal to 3 episodes a night.
  • Subject must be male or non-pregnant, non-lactating female who agrees to comply with applicable contraceptive requirements.
  • Subject understands and is able, will a nd and likely to fully comply with study procedures and restrictions.

Exclusion Criteria:

  • Subject has any concurrent chronic or acute illness or unstable medical condition either treated or untreated that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
  • The subject has a known or suspected allergy, hypersensitivity, or other medical contraindications to darifenacin (Enablex®) (or its components).
  • The subject has concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, bladder obstruction, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, toxic megacolon, and patients who are at risk for these conditions.
  • Subject is taking another drug which is considered to have significant anticholinergic activity.
  • Use of drugs known to effect cognition, alertness or drowsiness, such as benzodiazepines, sedating antihistamines, opioids, or other sedative hypnotic drugs.
  • Subject has moderate to severe obstructive sleep apnea (Apnea/Hypopnea Index ≥ 15)
  • Subject has a medical condition other than OAB that is the most likely cause of the subject's nocturia (e.g., primary sleep disorder, polydipsia, polyuria).
  • Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
  • The female subject is pregnant or lactating.
  • Subjects with a urine drug screen positive for stimulants, barbiturates, hallucinogens, opiates, cocaine, cannabis, or amphetamines
  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.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01018225     History of Changes
Other Study ID Numbers: CRC090001
Study First Received: November 20, 2009
Last Updated: July 27, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Darifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014