- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00124306
Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS) (IC01)
A Randomized Multicenter Clinical Trial to Evaluate the Efficacy of Amitriptyline for the Treatment of Painful Bladder Syndrome (PBS) in Newly Diagnosed Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current trial is recruiting newly diagnosed adults who have not yet received treatment. Approximately 270 participants will be randomly assigned to take up to 75 milligrams of amitriptyline or a placebo each day for 14 to 26 weeks. All participants will be given techniques to practice suppressing the urge to urinate for increasingly longer stretches until they can wait 3 or 4 hours before going to the bathroom. Participants will also regulate when and how much they drink and avoid bladder irritants such as alcohol, acidic foods and carbonated or caffeinated drinks. Staff and patients will find out who received the amitriptyline when the study is finished. Medications and tests are free to participants.
Ten medical centers in the United States and Canada are recruiting adults newly diagnosed with either painful bladder syndrome (PBS) or interstitial cystitis (IC).The centers make up the Interstitial Cystitis Clinical Research Network, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at NIH.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L 2Y7
- Queen's University
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-
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California
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Stanford, California, United States, 94305
- Stanford University Medical Center
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinic
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
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New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participant must report bladder pain/discomfort score of 3 or greater on a 0-10 Likert scale over the previous 4 weeks.
- Participant must report a symptom score of abnormal urinary frequency of 3 or greater on a 0-10 Likert scale over the previous 4 weeks.
- Symptoms of abnormal urinary frequency and bladder pain/discomfort must have been present for at least six weeks prior to screening visit.
Exclusion Criteria:
- Known allergy or intolerance to amitriptyline or any of its components.
- Currently receives treatment with amitriptyline or other tricyclic antidepressant, selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), or monoamine oxidase (MAO) inhibitor antidepressants.
- Previous treatment with amitriptyline or other tricyclics, hydroxyzine or other antihistamines for bladder symptoms; pentosanpolysulfate; DMSO or any other intravesical therapy, biofeedback or pelvic floor physical therapy for PBS symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Amitryptiline
|
Amitriptyline will be titrated over a 6-week period as tolerated, to a maximum dose of 75mg.
During the 6-week titration period, the patient who cannot tolerate a scheduled increased dose may adjust the medication dose for tolerance by tapering down one 25mg tablet.
|
Placebo Comparator: 2
Placebo will be dosed exactly as active arm.
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Placebo will be dosed exactly as active arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Global Response Assessment (GRA)
Time Frame: 12 Weeks
|
12 Weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life measures
Time Frame: 12 Weeks
|
12 Weeks
|
Urinary symptoms measures
Time Frame: 12 Weeks
|
12 Weeks
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Urinary biomarkers
Time Frame: 12 Weeks
|
12 Weeks
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Adherence to urinary educational/behavioral program
Time Frame: 12 weeks
|
12 weeks
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Adverse events
Time Frame: 12 Weeks
|
12 Weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Leroy M. Nyberg, Jr., Ph.D, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publications and helpful links
General Publications
- Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
- Foster HE Jr, Hanno PM, Nickel JC, Payne CK, Mayer RD, Burks DA, Yang CC, Chai TC, Kreder KJ, Peters KM, Lukacz ES, FitzGerald MP, Cen L, Landis JR, Propert KJ, Yang W, Kusek JW, Nyberg LM; Interstitial Cystitis Collaborative Research Network. Effect of amitriptyline on symptoms in treatment naive patients with interstitial cystitis/painful bladder syndrome. J Urol. 2010 May;183(5):1853-8. doi: 10.1016/j.juro.2009.12.106. Epub 2010 Mar 29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Cystitis
- Cystitis, Interstitial
- Urinary Bladder Diseases
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Adrenergic Uptake Inhibitors
- Amitriptyline
Other Study ID Numbers
- ICCRN (IND)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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