Trial · NCT00295854
Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
NCT00295854, Phase 2, Completed, MediciNova; results first posted 2012-01-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis. Trials, record NCT00295854. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00295854
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
- NCT number
- NCT00295854
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 296 participants, actual
- Lead sponsor
- MediciNova
- Conditions
- Interstitial Cystitis
- Interventions
- MN-001 BID, MN-001, Placebo
- First posted
- 2006-02-24
- Last updated
- 2012-01-19
- Results first posted
- 2012-01-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number Subjects at Least "Moderately Improved" for Each Treatment Group in Patient Reported Global Response Assessment (GRA) | 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. |
| Secondary | Number of Responders for GRA Assessment in Their Condition at Week 4. | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Responders for GRA Assessment in Their Condition at Week 4. | 4 weeks | participants | NUMBER | |
| PRIMARY | Number Subjects at Least Moderately Improved for Each Treatment Group in Patient Reported Global Response Assessment (GRA) | 8 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Responders for GRA Assessment in Their Condition at Week 4. | MN-001 500 mg qd | 19 | participants | ||
| Number of Responders for GRA Assessment in Their Condition at Week 4. | MN-001 500 mg BID | 26 | participants | ||
| Number of Responders for GRA Assessment in Their Condition at Week 4. | Placebo | 12 | participants | ||
| Number Subjects at Least Moderately Improved for Each Treatment Group in Patient Reported Global Response Assessment (GRA) | MN-001 500 mg qd | 31 | participants | ||
| Number Subjects at Least Moderately Improved for Each Treatment Group in Patient Reported Global Response Assessment (GRA) | MN-001 500 mg BID | 26 | participants | ||
| Number Subjects at Least Moderately Improved for Each Treatment Group in Patient Reported Global Response Assessment (GRA) | Placebo | 30 | participants |
Source ClinicalTrials.gov
Participant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MN-001 500 mg qd | 95 | |
| Overall Study | STARTED | MN-001 500 mg BID | 108 | |
| Overall Study | STARTED | Placebo | 102 | |
| Overall Study | Safety Population (N=304) | MN-001 500 mg qd | 95 | |
| Overall Study | Safety Population (N=304) | MN-001 500 mg BID | 108 | |
| Overall Study | Safety Population (N=304) | Placebo | 101 | |
| Overall Study | ITT Population (N=296) | MN-001 500 mg qd | 92 | |
| Overall Study | ITT Population (N=296) | MN-001 500 mg BID | 105 | |
| Overall Study | ITT Population (N=296) | Placebo | 99 | |
| Overall Study | COMPLETED | MN-001 500 mg qd | 77 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | MN-001 500 mg qd | 11 | 92 | 12 |
| other | Diarrhea | Gastrointestinal disorders | MN-001 500 mg BID | 24 | 105 | 30 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 5 | 99 | 5 |
| other | Nausea | Gastrointestinal disorders | MN-001 500 mg qd | 10 | 92 | 12 |
| other | Nausea | Gastrointestinal disorders | MN-001 500 mg BID | 11 | 105 | 13 |
| other | Nausea | Gastrointestinal disorders | Placebo | 7 | 99 | 7 |
| other | Loose stools | Gastrointestinal disorders | MN-001 500 mg qd | 5 | 92 | 6 |
| other | Loose stools | Gastrointestinal disorders | MN-001 500 mg BID | 14 | 105 | 16 |
| other | Loose stools | Gastrointestinal disorders | Placebo | 3 | 99 | 4 |
| other | Urinary tract infection | Renal and urinary disorders | MN-001 500 mg qd | 2 | 92 | 2 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MN-001 500 mg qd | ||
| Total, all-cause mortality | MN-001 500 mg BID | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | MN-001 500 mg qd | 48 | 92 |
| Total, other adverse events | MN-001 500 mg BID | 65 | 105 |
| Total, other adverse events | Placebo | 28 | 99 |
| Total, serious adverse events | MN-001 500 mg qd | 1 | 92 |
| Total, serious adverse events | MN-001 500 mg BID | 0 | 105 |
| Total, serious adverse events | Placebo | 1 | 99 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00295854
GET https://conductscience.org/api/trials/v1/NCT00295854/events?page=2