Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004316
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
1999-10-18
Brief Title:
Phase III Randomized Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-09
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:
None
Brief Summary:
OBJECTIVES I Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis
II Evaluate the efficacy of 0025 topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis
III Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin
IV Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin
II Evaluate the efficacy of 0025 topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis
III Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin
IV Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin
Detailed Description:
PROTOCOL OUTLINE This is a randomized study Patients with interstitial cystitis are randomly assigned to 1 of 3 pain control therapies
The first group is treated with capsaicin A second group is given individually titrated doses of capsaicin the dose is increased as tolerated or until symptomatic response is acceptable A control group receives a placebo Therapy for all groups is administered intravesically every week for 5 weeks
Patients with vulvar vestibulitis are randomly assigned to 1 of 2 pain control therapies One group applies topical capsaicin cream to the painful area 4 times a day for 6 weeks The dose is individually titrated if burning discomfort persists and the patient is compliant with the application schedule The control group applies a placebo
Patients with vulvar vestibulitis may continue or cross to capsaicin for 6 additional weeks
The first group is treated with capsaicin A second group is given individually titrated doses of capsaicin the dose is increased as tolerated or until symptomatic response is acceptable A control group receives a placebo Therapy for all groups is administered intravesically every week for 5 weeks
Patients with vulvar vestibulitis are randomly assigned to 1 of 2 pain control therapies One group applies topical capsaicin cream to the painful area 4 times a day for 6 weeks The dose is individually titrated if burning discomfort persists and the patient is compliant with the application schedule The control group applies a placebo
Patients with vulvar vestibulitis may continue or cross to capsaicin for 6 additional weeks
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UPMC-950666 | None | None | None |