Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295854
Status:
COMPLETED
Last Update Posted:
2012-01-19
First Post:
2006-02-22
Brief Title:
Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
Sponsor:
MediciNova
Organization:
MediciNova
Study Overview
Official Title:
A Phase II Randomized Double-blind Placebo-controlled Multi-center Study to Evaluate the Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
Status:
COMPLETED
Status Verified Date:
2011-12
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:
To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid 500 mg once daily vs placebo in patients with Interstitial Cystitis
Detailed Description:
This is a randomized double-blind placebo-controlled multi-center study to evaluate the efficacy and safety of two dosing regimens of MN-001 in patients with Interstitial Cystitis IC Patients will be screened for study eligibility within seven to nine days of randomization Eligible patients will be randomized in a 111 ratio to receive either 500 mg MN-001 bid 500 mg MN-001 once daily or placebo Patients will be dispensed study drug beginning at Baseline Visit 2 and will return to the study center for Visit 3 28 days 2 days after Baseline and Visit 4 56 days 2 days after Baseline at end of study for safety and efficacy assessments The patient will be contacted by telephone at Week 6 42 days 2 days after Baseline for an interim follow up Study drug will be dispensed at Visits 2 and 3 Safety assessments will include adverse events physical examinations clinical laboratory testing and changes in vital signs Efficacy assessments include percentage of patients at least moderately improved for each treatment group using the patient reported Global Response Assessment GRA see Appendix 1 Secondary assessments include a decrease in bladder painurgency based on change in the patient rating from baseline to endpoint using the GRA see Appendix 1 modified Pelvic Pain and UrgencyFrequency PUF Patient Symptom Scale see Appendix 2 and the OLeary Sant IC Symptom and Problem Index
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