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

Purpose

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.

Condition	Intervention	Phase
Interstitial Cystitis	Drug: MN-001 BID Drug: MN-001 Drug: Placebo	Phase 2


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

Resource links provided by NLM:

MedlinePlus related topics: Interstitial Cystitis

U.S. FDA Resources

Further study details as provided by MediciNova:

Primary Outcome Measures:

Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Number of Responders for GRA Assessment in Their Condition at Week 4. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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.


Enrollment:	296
Study Start Date:	May 2005
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MN-001	Drug: MN-001 BID Eligible patients received 500 mg MN-001 bid Drug: MN-001 Eligible patients received 500 mg MN-001 once daily (qd)
Placebo Comparator: MN-001 once daily placebo tablets	Drug: Placebo Eligible patients received placebo

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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295854

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Sponsors and Collaborators

MediciNova

Investigators


Study Director:	Richard E Gammans, MD	MediciNova, Inc.

More Information

No publications provided


Responsible Party:	MediciNova
ClinicalTrials.gov Identifier:	NCT00295854 History of Changes
Other Study ID Numbers:	MN-001-CL-002
Study First Received:	February 22, 2006
Results First Received:	February 16, 2011
Last Updated:	December 16, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by MediciNova:


Interstitial Cystitis urgency frequency MN-001	Global Response Assessment bladder pain/urgency O'Leary Sant IC Symptom and Problem Index

Additional relevant MeSH terms:


Cystitis Cystitis, Interstitial Urinary Bladder Diseases Urologic Diseases

ClinicalTrials.gov processed this record on February 27, 2015