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

Interstitial Cystitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295854
• Other study ID #: MN-001-CL-002
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2006
• Last updated: December 16, 2011
• Start date: May 2005
• Est. completion date: October 2006

Study information

• Verified date: December 2011
• Source: MediciNova
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Drug:
• MN-001 BID
Eligible patients received 500 mg MN-001 bid
• MN-001
Eligible patients received 500 mg MN-001 once daily (qd)
• Placebo
Eligible patients received placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MediciNova

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No