Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)

Interstitial Cystitis Clinical Trial

— IC01  

Official title:

A Randomized Multicenter Clinical Trial to Evaluate the Efficacy of Amitriptyline for the Treatment of Painful Bladder Syndrome (PBS) in Newly Diagnosed Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00124306
• Other study ID #: ICCRN (IND)
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2005
• Last updated: October 28, 2013
• Start date: February 2005
• Est. completion date: December 2008

Study information

• Verified date: October 2013
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: December 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bladder Diseases
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Urinary Bladder Diseases

Intervention

Drug:
• Amitriptyline
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.

Other:
• Placebo
Placebo will be dosed exactly as active arm.

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario
United States	University of Maryland	Baltimore	Maryland
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Iowa Hospitals and Clinic	Iowa City	Iowa
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Rochester Medical Center	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University of Washington	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	University of Pennsylvania

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Response Assessment (GRA)		12 Weeks	Yes
Secondary	Quality of life measures		12 Weeks	Yes
Secondary	Urinary symptoms measures		12 Weeks	No
Secondary	Urinary biomarkers		12 Weeks	No
Secondary	Adherence to urinary educational/behavioral program		12 weeks	No
Secondary	Adverse events		12 Weeks	Yes