Trial Outcomes & Findings for Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis (NCT NCT00295854)

NCT ID: NCT00295854

Last Updated: 2012-01-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 296 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2012-01-19

Participant Flow

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).

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.

Participant milestones

Measure	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.
Overall Study STARTED	95	108	102
Overall Study Safety Population (N=304)	95	108	101
Overall Study ITT Population (N=296)	92	105	99
Overall Study COMPLETED	77	87	87
Overall Study NOT COMPLETED	18	21	15

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	7	7	6
Overall Study Protocol Violation	1	1	1
Overall Study Lost to Follow-up	2	0	1
Overall Study Withdrawal by Subject	3	7	4
Overall Study did not continue to meet criteria	1	1	2
Overall Study required a prohibited medication	1	0	0
Overall Study Other	3	5	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	MN-001 500 mg qd n=95 Participants 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 n=108 Participants 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 n=102 Participants 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.	Total n=305 Participants Total of all reporting groups
Age Continuous	45.2 years STANDARD_DEVIATION 12.87 • n=5 Participants	43.5 years STANDARD_DEVIATION 13.95 • n=7 Participants	43.4 years STANDARD_DEVIATION 13.97 • n=5 Participants	44 years STANDARD_DEVIATION 13.6 • n=4 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	97 Participants n=7 Participants	92 Participants n=5 Participants	271 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	34 Participants n=4 Participants
Region of Enrollment United States	95 participants n=5 Participants	108 participants n=7 Participants	102 participants n=5 Participants	305 participants n=4 Participants
diagnosis of moderate to severe interstitial cystitis (IC) with bladder pain for ≥ 6 months <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
diagnosis of moderate to severe interstitial cystitis (IC) with bladder pain for ≥ 6 months Over 18 years old	95 participants n=5 Participants	108 participants n=7 Participants	102 participants n=5 Participants	305 participants n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Measure	MN-001 500 mg qd n=95 Participants 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 n=108 Participants 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 n=102 Participants 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.
Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA)	31 participants	26 participants	30 participants

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Measure	MN-001 500 mg qd n=92 Participants 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 n=105 Participants 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 n=99 Participants 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.
Number of Responders for GRA Assessment in Their Condition at Week 4.	19 participants	26 participants	12 participants

Adverse Events

MN-001 500 mg qd

Serious events: 1 serious events

Other events: 48 other events

Deaths: 0 deaths

MN-001 500 mg BID

Serious events: 0 serious events

Other events: 65 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	MN-001 500 mg qd n=92 participants at risk 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 n=105 participants at risk 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 n=99 participants at risk 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.
Pregnancy, puerperium and perinatal conditions Pregnancy	1.1% 1/92 • Number of events 1 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	0.00% 0/105 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	0.00% 0/99 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.
Skin and subcutaneous tissue disorders infected epidermal cyst	0.00% 0/92 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	0.00% 0/105 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	1.0% 1/99 • Number of events 1 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.

Other adverse events

Measure	MN-001 500 mg qd n=92 participants at risk 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 n=105 participants at risk 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 n=99 participants at risk 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.
Nervous system disorders Headache	9.8% 9/92 • Number of events 10 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	8.6% 9/105 • Number of events 10 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	4.0% 4/99 • Number of events 4 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.
Gastrointestinal disorders Diarrhea	12.0% 11/92 • Number of events 12 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	22.9% 24/105 • Number of events 30 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	5.1% 5/99 • Number of events 5 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.
Gastrointestinal disorders Nausea	10.9% 10/92 • Number of events 12 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	10.5% 11/105 • Number of events 13 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	7.1% 7/99 • Number of events 7 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.
Gastrointestinal disorders Loose stools	5.4% 5/92 • Number of events 6 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	13.3% 14/105 • Number of events 16 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	3.0% 3/99 • Number of events 4 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.
Renal and urinary disorders Urinary tract infection	2.2% 2/92 • Number of events 2 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	5.7% 6/105 • Number of events 8 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	3.0% 3/99 • Number of events 3 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.
Nervous system disorders Dizziness	6.5% 6/92 • Number of events 7 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	0.95% 1/105 • Number of events 1 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	2.0% 2/99 • Number of events 2 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.
Renal and urinary disorders Interstitial Cystitis	5.4% 5/92 • Number of events 5 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	0.00% 0/105 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.	4.0% 4/99 • Number of events 4 • The mean days of exposure to study drug was similar in the three treatment groups and ranged between 1 to 69 days. Adverse event reporting started on Day 1 of study drug exposure for each patient who received study drug or placebo. Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.

Additional Information

Richard E. Gammans PhD Chief Developing Officer

Medicinova Inc

Phone: 848-373-1500

Email: gammans@medicinova.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60