Conditions: Interstitial Cystitis
Keywords: Interstitial Cystitis urgency frequency MN-001 Global Response Assessment bladder pain/urgency O'Leary Sant IC Symptom and Problem Index
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 296
Healthy volunteers: no

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 1:1:1 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 pain/urgency based on change in the patient rating from baseline to endpoint using the GRA (see Appendix 1), modified Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale (see Appendix 2) and the O'Leary Sant IC Symptom and Problem Index.

Arms:
arm 1: None arm 2: placebo tablets

Interventions: intervention 1: MN-001 BID intervention 2: MN-001 intervention 3: Placebo
Intervention descriptions: intervention 1: Eligible patients received 500 mg MN-001 bid intervention 2: Eligible patients received 500 mg MN-001 once daily (qd) intervention 3: Eligible patients received placebo

Protocol document: