Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis

NCT ID: NCT00295854

Last Updated: 2012-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-10-31

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.

Conditions

Interstitial Cystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MN-001

Group Type: EXPERIMENTAL

MN-001 BID

Intervention Type: DRUG

Eligible patients received 500 mg MN-001 bid

MN-001

Intervention Type: DRUG

Eligible patients received 500 mg MN-001 once daily (qd)

MN-001 once daily

placebo tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Eligible patients received placebo

Interventions

MN-001 BID

Eligible patients received 500 mg MN-001 bid

Intervention Type: DRUG

MN-001

Eligible patients received 500 mg MN-001 once daily (qd)

Intervention Type: DRUG

Placebo

Eligible patients received placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female ≥ 18 years of age with a diagnosis of moderate to severe IC;
• Bladder pain ≥ 6 months prior to baseline;
• Urinary frequency of ≥ 8 ≤ 30 micturitions within 24 hours while awake;
• Nocturia ≥ 2x/night;
• Males and females of child-bearing potential (not surgically sterile or post-menopausal) must be abstinent or agree to use an study-accepted contraceptive regimens throughout the study:
• Female patients of child bearing age must have a negative urine pregnancy test at screening;
• Must provide a signed informed consent.

Exclusion Criteria

• Male or females < 18 years of age;
• Initiation of new IC medication ≤ 30 days prior to baseline;
• Treatment with Elmiron ≤ 120 days prior to baseline;
• Treatment with bladder hydro-distention ≤ 6 months prior to baseline;
• Treatment with intravesical therapy ≤ 60 days prior to baseline;
• History of previous procedure(s) (e.g., augmentation cytoplasty, cystectomy or cystolysis) that has affected bladder function;
• Active genital herpes or vaginitis ≤ 90 days prior to baseline;
• Urinary tract or prostatic infection ≤ 90 days prior to baseline;
• History of urethral diverticulum;
• History of bladder or ureteral calculi;
• History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis;
• History of bladder tumors;
• History of uterine, cervical, vaginal, prostatic or urethral cancer ≤ 5 years prior to baseline;
• Patient is currently pregnant, lactating or likely to become pregnant during the study;
• Participated in another clinical study with an investigational drug or device ≤ 30 days prior to baseline.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MediciNova

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard E Gammans, MD

Role: STUDY_DIRECTOR

MediciNova, Inc.

Locations

MediciNova Investigational Site

Birmingham, Alabama, United States

Citrus Valley Urological Medical Group

Glendora, California, United States

Atlantic Urological Medical Group

Long Beach, California, United States

Mendez Transplant and Urological Medical Group

San Diego, California, United States

Boulder Medical Center, P.C.

Boulder, Colorado, United States

Western Urologic Research Center

Wheat Ridge, Colorado, United States

Segal Institute for Clinical Research

Aventura, Florida, United States

Visions Clinical Research

Boynton Beach, Florida, United States

West Florida Urology

Palm Harbor, Florida, United States

Adult and Pediatric Urology

Plantation, Florida, United States

Georgis Patsias, MD., PA

Wellington, Florida, United States

Shepherd Center, Inc.

Atlanta, Georgia, United States

Center For Advanced Pelvic Surgery

Centralia, Illinois, United States

Evanston Continence Center

Evanston, Illinois, United States

Regional Urology, LLC

Shreveport, Louisiana, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Sheldon J. Freedman, MD, LTD

Las Vegas, Nevada, United States

Associated Urologic Specialists, P.A.

Marlton, New Jersey, United States

Upstate Urology

Albany, New York, United States

Lyndhurst Gynecology Associates

Winston-Salem, North Carolina, United States

Tristate Urologic Services PSC., Inc.

Cincinnati, Ohio, United States

Midwest Regional Center For Chronic Pelvic Pain and Bladder Control

Lima, Ohio, United States

Williamette Women's Healthcare P.C.

Tualatin, Oregon, United States

The Urology Group

Greer, South Carolina, United States

Medical Arts Clinic

Corsicana, Texas, United States

Gant Foundation

Fort Worth, Texas, United States

Brian Heaton, MD

Ogden, Utah, United States

Integrity Medical Research, LLC

Mountlake Terrace, Washington, United States

Countries

United States

Other Identifiers

MN-001-CL-002

Identifier Type: -

Identifier Source: org_study_id