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

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

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis
• Intervention / Treatment: Drug: MN-001 BID; Drug: MN-001; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • MediciNova Investigational Site
  • California
    • Glendora, California, United States, 91741
      • Citrus Valley Urological Medical Group
    • Long Beach, California, United States, 90806
      • Atlantic Urological Medical Group
    • San Diego, California, United States, 92103
      • Mendez Transplant and Urological Medical Group
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Boulder Medical Center, P.C.
    • Wheat Ridge, Colorado, United States, 80033
      • Western Urologic Research Center
  • Florida
    • Aventura, Florida, United States, 33180
      • Segal Institute for Clinical Research
    • Boynton Beach, Florida, United States, 33437
      • Visions Clinical Research
    • Palm Harbor, Florida, United States, 34684
      • West Florida Urology
    • Plantation, Florida, United States, 33317
      • Adult and Pediatric Urology
    • Wellington, Florida, United States, 33414
      • Georgis Patsias, MD., PA
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center, Inc.
  • Illinois
    • Centralia, Illinois, United States, 62801
      • Center For Advanced Pelvic Surgery
    • Evanston, Illinois, United States, 60201
      • Evanston Continence Center
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Sheldon J. Freedman, MD, LTD
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Associated Urologic Specialists, P.A.
  • New York
    • Albany, New York, United States, 12206
      • Upstate Urology
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Gynecology Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Tristate Urologic Services PSC., Inc.
    • Lima, Ohio, United States, 45805
      • Midwest Regional Center For Chronic Pelvic Pain and Bladder Control
  • Oregon
    • Tualatin, Oregon, United States, 97062
      • Williamette Women's Healthcare P.C.
  • South Carolina
    • Greer, South Carolina, United States, 29650
      • The Urology Group
  • Texas
    • Corsicana, Texas, United States, 75110
      • Medical Arts Clinic
    • Fort Worth, Texas, United States, 76104
      • Gant Foundation
  • Utah
    • Ogden, Utah, United States, 84403
      • Brian Heaton, MD
  • Washington
    • Mountlake Terrace, Washington, United States, 98043
      • Integrity Medical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MN-001	Drug: MN-001 BID; Eligible patients received 500 mg MN-001 bid; Drug: MN-001; Eligible patients received 500 mg MN-001 once daily (qd)
Placebo Comparator: MN-001 once daily; placebo tablets	Drug: Placebo; Eligible patients received placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA)	The primary endpoint was the GRA overall change "in their condition" at Week 8. Each patient completed the questionnaire that rated the improvement in their IC symptoms based on responses to the GRA questions. Each question asked the patient to describe the OVERALL CHANGE in pain, urgency, frequency or overall change in their problem compared to the status before taking the study medication. Each parameter was rated on a 7 point scale: markedly worse, moderately worse, mildly worse, same, mildly improved, moderately improved and markedly improved.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Responders for GRA Assessment in Their Condition at Week 4.	Responders were defined as patients who were 'moderately improved' or 'markedly improved' and non-responders were defined as patients who were 'markedly worse', 'moderately worse', 'mildly worse', no change, or 'mildly improved' on the GRA assessments.	4 weeks

Collaborators and Investigators

• Sponsor: MediciNova
• Investigators: Study Director: Richard E Gammans, MD, MediciNova, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: February 22, 2006
• First Submitted That Met QC Criteria: February 22, 2006
• First Posted (Estimate): February 24, 2006

Study Record Updates

• Last Update Posted (Estimate): January 19, 2012
• Last Update Submitted That Met QC Criteria: December 16, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Interstitial Cystitis; urgency; frequency; MN-001; Global Response Assessment; bladder pain/urgency; O'Leary Sant IC Symptom and Problem Index
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial
• Other Study ID Numbers: MN-001-CL-002