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
1 other identifier
interventional
296
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2005
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 22, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedResults Posted
Study results publicly available
January 19, 2012
CompletedJanuary 19, 2012
December 1, 2011
1.4 years
February 22, 2006
February 16, 2011
December 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Number of Responders for GRA Assessment in Their Condition at Week 4.
4 weeks
Study Arms (2)
MN-001
EXPERIMENTALMN-001 once daily
PLACEBO COMPARATORplacebo tablets
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MediciNovalead
Study Sites (28)
MediciNova Investigational Site
Birmingham, Alabama, 35294, United States
Citrus Valley Urological Medical Group
Glendora, California, 91741, United States
Atlantic Urological Medical Group
Long Beach, California, 90806, United States
Mendez Transplant and Urological Medical Group
San Diego, California, 92103, United States
Boulder Medical Center, P.C.
Boulder, Colorado, 80304, United States
Western Urologic Research Center
Wheat Ridge, Colorado, 80033, United States
Segal Institute for Clinical Research
Aventura, Florida, 33180, United States
Visions Clinical Research
Boynton Beach, Florida, 33437, United States
West Florida Urology
Palm Harbor, Florida, 34684, United States
Adult and Pediatric Urology
Plantation, Florida, 33317, United States
Georgis Patsias, MD., PA
Wellington, Florida, 33414, United States
Shepherd Center, Inc.
Atlanta, Georgia, 30309, United States
Center For Advanced Pelvic Surgery
Centralia, Illinois, 62801, United States
Evanston Continence Center
Evanston, Illinois, 60201, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Sheldon J. Freedman, MD, LTD
Las Vegas, Nevada, 89109, United States
Associated Urologic Specialists, P.A.
Marlton, New Jersey, 08053, United States
Upstate Urology
Albany, New York, 12206, United States
Lyndhurst Gynecology Associates
Winston-Salem, North Carolina, 27103, United States
Tristate Urologic Services PSC., Inc.
Cincinnati, Ohio, 45212, United States
Midwest Regional Center For Chronic Pelvic Pain and Bladder Control
Lima, Ohio, 45805, United States
Williamette Women's Healthcare P.C.
Tualatin, Oregon, 97062, United States
The Urology Group
Greer, South Carolina, 29650, United States
Medical Arts Clinic
Corsicana, Texas, 75110, United States
Gant Foundation
Fort Worth, Texas, 76104, United States
Brian Heaton, MD
Ogden, Utah, 84403, United States
Integrity Medical Research, LLC
Mountlake Terrace, Washington, 98043, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard E. Gammans PhD Chief Developing Officer
- Organization
- Medicinova Inc
Study Officials
- STUDY DIRECTOR
Richard E Gammans, MD
MediciNova, Inc.
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2006
First Posted
February 24, 2006
Study Start
May 1, 2005
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
January 19, 2012
Results First Posted
January 19, 2012
Record last verified: 2011-12