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

Completed · Phase 2 · Has a placebo group

Conditions studied: Interstitial Cystitis

In brief

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.

Key facts

Study ID

NCT00295854

Run by

MediciNova

People needed

296

Starts

2005-05-01

Expected to finish

2006-10-01

Last updated by the study team

2012-01-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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