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Trial record 54 of 158 for:    interstitial cystitis

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

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ClinicalTrials.gov Identifier: NCT00295854
Recruitment Status : Completed
First Posted : February 24, 2006
Results First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
MediciNova

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Interstitial Cystitis
Interventions Drug: MN-001 BID
Drug: MN-001
Drug: Placebo
Enrollment 296
Recruitment Details 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 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.
Arm/Group Title MN-001 500 mg qd MN-001 500 mg BID Placebo
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title MN-001 500 mg qd MN-001 500 mg BID Placebo Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 95 108 102 305
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 108 participants 102 participants 305 participants
45.2  (12.87) 43.5  (13.95) 43.4  (13.97) 44  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 108 participants 102 participants 305 participants
Female
82
  86.3%
97
  89.8%
92
  90.2%
271
  88.9%
Male
13
  13.7%
11
  10.2%
10
   9.8%
34
  11.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 95 participants 108 participants 102 participants 305 participants
95 108 102 305
diagnosis of moderate to severe interstitial cystitis (IC) with bladder pain for ≥ 6 months   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 95 participants 108 participants 102 participants 305 participants
<=18 years 0 0 0 0
Over 18 years old 95 108 102 305
[1]
Measure Description: 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.Primary Outcome
Title Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA)
Hide Description 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.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MN-001 500 mg qd MN-001 500 mg BID Placebo
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 95 108 102
Measure Type: Number
Unit of Measure: participants
31 26 30
2.Secondary Outcome
Title Number of Responders for GRA Assessment in Their Condition at Week 4.
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MN-001 500 mg qd MN-001 500 mg BID Placebo
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 92 105 99
Measure Type: Number
Unit of Measure: participants
19 26 12
Time Frame 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.
Adverse Event Reporting Description Safety assessments included adverse events (AEs), physical examinations, vital signs, 12 lead ECGs and clinical laboratory testing.
 
Arm/Group Title MN-001 500 mg qd MN-001 500 mg BID Placebo
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
MN-001 500 mg qd MN-001 500 mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MN-001 500 mg qd MN-001 500 mg BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/92 (1.09%)      0/105 (0.00%)      1/99 (1.01%)    
Pregnancy, puerperium and perinatal conditions       
Pregnancy * 1 [1]  1/92 (1.09%)  1 0/105 (0.00%)  0 0/99 (0.00%)  0
Skin and subcutaneous tissue disorders       
infected epidermal cyst * 1 [2]  0/92 (0.00%)  0 0/105 (0.00%)  0 1/99 (1.01%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (7.1)
[1]
22 y.o. patient notified site of pregnancy.Female infant reported to have a severe coloboma of retina, iris.Event was continuing at the time of report.No further information available. P.I. opinion: event was possibly related to the study medication.
[2]
56 y.o. female,epidermal cyst of R thigh,incision,drainage.Hospitalized for worsening cellulitis and had repeat incision,drainage,excision of the cyst, treated with ABs. Recovered from SAE 2 mo later.TEAE considered possibly related to study drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MN-001 500 mg qd MN-001 500 mg BID Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/92 (52.17%)      65/105 (61.90%)      28/99 (28.28%)    
Gastrointestinal disorders       
Diarrhea  1  11/92 (11.96%)  12 24/105 (22.86%)  30 5/99 (5.05%)  5
Nausea  1  10/92 (10.87%)  12 11/105 (10.48%)  13 7/99 (7.07%)  7
Loose stools  1  5/92 (5.43%)  6 14/105 (13.33%)  16 3/99 (3.03%)  4
Nervous system disorders       
Headache  1  9/92 (9.78%)  10 9/105 (8.57%)  10 4/99 (4.04%)  4
Dizziness  1  6/92 (6.52%)  7 1/105 (0.95%)  1 2/99 (2.02%)  2
Renal and urinary disorders       
Urinary tract infection  1  2/92 (2.17%)  2 6/105 (5.71%)  8 3/99 (3.03%)  3
Interstitial Cystitis  1  5/92 (5.43%)  5 0/105 (0.00%)  0 4/99 (4.04%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Richard E. Gammans PhD Chief Developing Officer
Organization: Medicinova Inc
Phone: 848-373-1500
Responsible Party: MediciNova
ClinicalTrials.gov Identifier: NCT00295854     History of Changes
Other Study ID Numbers: MN-001-CL-002
First Submitted: February 22, 2006
First Posted: February 24, 2006
Results First Submitted: February 16, 2011
Results First Posted: January 19, 2012
Last Update Posted: January 19, 2012