Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124306
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
2005-07-13
Brief Title:
Efficacy of Amitriptyline for Painful Bladder Syndrome PBS
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IC01
Brief 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 700000 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
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 ICThe centers make up the Interstitial Cystitis Clinical Research Network sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases NIDDK at NIH
Ten medical centers in the United States and Canada are recruiting adults newly diagnosed with either painful bladder syndrome PBS or interstitial cystitis ICThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None