Status:
COMPLETED
Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
Lead Sponsor:
MediciNova
Conditions:
Interstitial Cystitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT00295854
Start Date
May 1 2005
End Date
October 1 2006
Last Update
January 19 2012
Active Locations (28)
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1
MediciNova Investigational Site
Birmingham, Alabama, United States, 35294
2
Citrus Valley Urological Medical Group
Glendora, California, United States, 91741
3
Atlantic Urological Medical Group
Long Beach, California, United States, 90806
4
Mendez Transplant and Urological Medical Group
San Diego, California, United States, 92103