Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT00295854 |
Date of registration:
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22/02/2006 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
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Scientific title:
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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 |
Date of first enrolment:
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May 2005 |
Target sample size:
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296 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00295854 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Richard E Gammans, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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MediciNova, Inc. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Interstitial Cystitis
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Intervention(s)
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Drug: Placebo
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Drug: MN-001 BID
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Drug: MN-001
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Primary Outcome(s)
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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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Secondary Outcome(s)
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Number of Responders for GRA Assessment in Their Condition at Week 4.
[Time Frame: 4 weeks]
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Secondary ID(s)
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MN-001-CL-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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