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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Interstitial Cystitis | Drug: MN-001 BID Drug: MN-001 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 296 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, 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 |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | October 2006 |
Actual Study Completion Date : | October 2006 |

Arm | Intervention/treatment |
---|---|
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 |
- Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA) [ Time Frame: 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.
- Number of Responders for GRA Assessment in Their Condition at Week 4. [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295854

Study Director: | Richard E Gammans, MD | MediciNova, Inc. |
Responsible Party: | MediciNova |
ClinicalTrials.gov Identifier: | NCT00295854 |
Other Study ID Numbers: |
MN-001-CL-002 |
First Posted: | February 24, 2006 Key Record Dates |
Results First Posted: | January 19, 2012 |
Last Update Posted: | January 19, 2012 |
Last Verified: | December 2011 |
Interstitial Cystitis urgency frequency MN-001 |
Global Response Assessment bladder pain/urgency O'Leary Sant IC Symptom and Problem Index |
Cystitis Cystitis, Interstitial Urinary Bladder Diseases Urologic Diseases |