Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)

Study acronym: IC01
StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Secondary endpoints: details revised at 1 of 4 entriesv12
  2. Results first posted: Oct 7, 2025
    • Secondary endpoints: 5 to 4
    • Publications: details revised at 1 of 2 entries
    v11
  3. Trial status: Active, Not Recruiting to Completedv10
  4. 2 versions Re-verified since Mar 2, 2010, no change to tracked fieldsv8-v9
  5. Trial status: Recruiting to Active, Not Recruitingv7 Show 8 more changesShow less
    • Enrollment target: estimated 270 to confirmed 271
    • Primary completion date: Apr 2008
    • Study completion date: May 2007 to Dec 2008
    • Interventions: Amitriptyline (Drug) to Amitriptyline (Drug), Placebo (Other)
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised at 10 of 10 sites
    • Study arms: 0 to 2
    • Collaborators expanded, about 3 words
Show 5 earlier versionsHide 5 earlier versions
  1. 4 versions Re-verified since Jan 3, 2006, no change to tracked fieldsv3-v6
  2. Secondary endpoints revised (5)
    • Study description revised
    • Eligibility criteria expanded, about 2 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized clinical trial study to test the efficacy and safety of amitriptyline in the treatment of patients newly diagnosed with painful bladder syndrome (PBS). PBS is defined by symptoms--frequent urination day and night and increasing pain as the bladder fills--according to the International Continence Society. The syndrome includes interstitial cystitis (IC), which has been estimated to affect as many as 700,000 people, mostly women. Estimates for PBS vary widely, but as many as 10 million people may suffer from this condition. Although amitriptyline is a Food and Drug Administration (FDA)-approved medication used for depression, the way it works makes it useful for treating the pain of fibromyalgia, multiple sclerosis, and other chronic pain syndromes. Prior small studies in interstitial cystitis (IC) suggested the drug may be a wise choice for this syndrome as well, because it blocks nerve signals that trigger pain and may also decrease muscle spasms in the bladder, helping to relieve the symptoms of pain and frequent urination.
Trial Details
NCT Number NCT00124306
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators: University of Pennsylvania
Conditions
(from sponsor)		 Bladder Diseases, Interstitial Cystitis
Related terms Cystitis, Interstitial, Urinary Bladder Diseases
Enrollment 271 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov