Clinical trial NCT00295854: Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Interstitial Cystitis
Keywords: Interstitial Cystitis
urgency
frequency
MN-001
Global Response Assessment
bladder pain/urgency
O'Leary Sant IC Symptom and Problem Index
Lead sponsor: MediciNova
Sponsor class: INDUSTRY
First posted: 2006-02-24
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA)
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Responders for GRA Assessment in Their Condition at Week 4.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: MediciNova Investigational Site
state: Alabama
city: Glendora
country: United States
facility: Citrus Valley Urological Medical Group
state: California
city: Long Beach
country: United States
facility: Atlantic Urological Medical Group
state: California
city: San Diego
country: United States
facility: Mendez Transplant and Urological Medical Group
state: California
city: Boulder
country: United States
facility: Boulder Medical Center, P.C.
state: Colorado
city: Wheat Ridge
country: United States
facility: Western Urologic Research Center
state: Colorado
city: Aventura
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Palm Harbor
country: United States
facility: West Florida Urology
state: Florida
city: Plantation
country: United States
facility: Adult and Pediatric Urology
state: Florida
city: Wellington
country: United States
facility: Georgis Patsias, MD., PA
state: Florida
city: Atlanta
country: United States
facility: Shepherd Center, Inc.
state: Georgia
city: Centralia
country: United States
facility: Center For Advanced Pelvic Surgery
state: Illinois
city: Evanston
country: United States
facility: Evanston Continence Center
state: Illinois
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Las Vegas
country: United States
facility: Sheldon J. Freedman, MD, LTD
state: Nevada
city: Marlton
country: United States
facility: Associated Urologic Specialists, P.A.
state: New Jersey
city: Albany
country: United States
facility: Upstate Urology
state: New York
city: Winston-Salem
country: United States
facility: Lyndhurst Gynecology Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Tristate Urologic Services PSC., Inc.
state: Ohio
city: Lima
country: United States
facility: Midwest Regional Center For Chronic Pelvic Pain and Bladder Control
state: Ohio
city: Tualatin
country: United States
facility: Williamette Women's Healthcare P.C.
state: Oregon
city: Greer
country: United States
facility: The Urology Group
state: South Carolina
city: Corsicana
country: United States
facility: Medical Arts Clinic
state: Texas
city: Fort Worth
country: United States
facility: Gant Foundation
state: Texas
city: Ogden
country: United States
facility: Brian Heaton, MD
state: Utah
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research, LLC
state: Washington
Study officials:
affiliation: MediciNova, Inc.
name: Richard E Gammans, MD
role: STUDY_DIRECTOR
References: