Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00124306
• Date of registration: 13/07/2005
• Prospective Registration: No
• Primary sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Public title: Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS) IC01
• Scientific title: A Randomized Multicenter Clinical Trial to Evaluate the Efficacy of Amitriptyline for the Treatment of Painful Bladder Syndrome (PBS) in Newly Diagnosed Patients
• Date of first enrolment: February 2005
• Target sample size: 271
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00124306
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Leroy M. Nyberg, Jr., Ph.D, M.D.
• Affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bladder Diseases

Interstitial Cystitis

Intervention(s)

Drug: Amitriptyline

Other: Placebo

Primary Outcome(s)

Global Response Assessment (GRA) [Time Frame: 12 Weeks]

Secondary Outcome(s)

Urinary symptoms measures [Time Frame: 12 Weeks]

Adherence to urinary educational/behavioral program [Time Frame: 12 weeks]

Adverse events [Time Frame: 12 Weeks]

Urinary biomarkers [Time Frame: 12 Weeks]

Quality of life measures [Time Frame: 12 Weeks]

Secondary ID(s)

ICCRN (IND)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Pennsylvania