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

This study has been completed.

Study NCT00295854 Information provided by MediciNova

First Received on February 22, 2006. Last Updated on December 16, 2011 History of Changes

Results First Received: February 16, 2011

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
Condition:	Interstitial Cystitis
Interventions:	Drug: MN-001 BID Drug: MN-001 Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were screened for study eligibility within 7-9 days of randomization. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments prior to randomization at Visit 2 (Baseline Visit, Day 0).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible patients were randomized in a 1:1:1 ratio to receive 500 mg MN-001 twice daily (BID), 500 mg MN-001 once daily (QD), or placebo. Patients returned to the study center at Visit 3 (Day 28) and at Visit 4 (Week 8, Day 64) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3.

Reporting Groups

	Description
MN-001 500 mg qd	This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
MN-001 500 mg BID	Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
Placebo	Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.

Participant Flow: Overall Study

	MN-001 500 mg qd	MN-001 500 mg BID	Placebo
STARTED	95	108	102
Safety Population (N=304)	95	108	101
ITT Population (N=296)	92	105	99
COMPLETED	77	87	87
NOT COMPLETED	18	21	15
Adverse Event	7	7	6
Protocol Violation	1	1	1
Lost to Follow-up	2	0	1
Withdrawal by Subject	3	7	4
did not continue to meet criteria	1	1	2
required a prohibited medication	1	0	0
not specified	3	5	1

Baseline Characteristics

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Reporting Groups

	Description
MN-001 500 mg qd	This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
MN-001 500 mg BID	Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
Placebo	Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.

Baseline Measures

	MN-001 500 mg qd	MN-001 500 mg BID	Placebo	Total
Number of Participants [units: participants]	95	108	102	305
Age [units: years] Mean ± Standard Deviation	45.2 ± 12.87	43.5 ± 13.95	43.4 ± 13.97	44 ± 13.6
Gender [units: participants]
Female	82	97	92	271
Male	13	11	10	34
Region of Enrollment [units: participants]
United States	95	108	102	305
diagnosis of moderate to severe interstitial cystitis (IC) with bladder pain for ≥ 6 months ^[1] [units: participants]
<=18 years	0	0	0	0
Over 18 years old	95	108	102	305

[1]	Diagnosis of moderate to severe interstitial cystitis (IC) with bladder pain for ≥ 6 months prior to Baseline, a score of ≥ 15 on the Modified Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale, a score of ≥ 12 on the O’Leary Sant IC Symptom and Problem Index, urinary frequency of ≥ 8 ≤ 30 micturitions within 24 hours while awake, and a history of nocturia ≥ 2 x/night over an 8-hour period prior to screening or Baseline.

[1]

Diagnosis of moderate to severe interstitial cystitis (IC) with bladder pain for ≥ 6 months prior to Baseline, a score of ≥ 15 on the Modified Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale, a score of ≥ 12 on the O’Leary Sant IC Symptom and Problem Index, urinary frequency of ≥ 8 ≤ 30 micturitions within 24 hours while awake, and a history of nocturia ≥ 2 x/night over an 8-hour period prior to screening or Baseline.

Outcome Measures

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1. Primary:

Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA) [ Time Frame: 8 weeks ]

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2. Secondary:

Number of Responders for GRA Assessment in Their Condition at Week 4. [ Time Frame: 4 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Richard E. Gammans PhD Chief Developing Officer
Organization: Medicinova Inc
phone: 848-373-1500
e-mail: gammans@medicinova.com

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