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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 22, 2006 | ||||
| Last Updated Date | February 22, 2006 | ||||
| Start Date ICMJE | May 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Percentage of subjects at least “moderately improved” for each treatment group in patient reported Global Response Assessment (GRA) questionnaire at endpoint. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Decrease in bladder pain/urgency based on change in the subject rating scale from baseline to endpoint. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Phase II Study to Evaluate the Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg once daily vs. placebo in patients with Interstitial Cystitis. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Interstitial Cystitis | ||||
| Intervention ICMJE | Drug: MN-001 | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 291 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00295854 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | MN-001-CL-002 | ||||
| Study Sponsor ICMJE | MediciNova | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE | |||||
| Information Provided By | MediciNova | ||||
| Verification Date | February 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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