Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
19 February 2015 |
Main ID: |
NCT00124306 |
Date of registration:
|
13/07/2005 |
Prospective Registration:
|
No |
Primary sponsor: |
|
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. |
Address:
|
|
Telephone:
|
|
Email:
|
|
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
|
Interstitial Cystitis
|
Bladder Diseases
|
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]
|
Adverse events
[Time Frame: 12 Weeks]
|
Urinary biomarkers
[Time Frame: 12 Weeks]
|
Adherence to urinary educational/behavioral program
[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
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|