Trial · NCT01124149
Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
NCT01124149, Phase 4, Completed, Shire; results first posted 2013-12-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis. Trials, record NCT01124149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01124149
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
- NCT number
- NCT01124149
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 759 participants, actual
- Lead sponsor
- Shire
- Conditions
- Ulcerative Colitis
- Interventions
- MMX mesalamine/ mesalazine
- First posted
- 2010-05-14
- Last updated
- 2021-06-09
- Other registries' IDs
- eudract:2009-017044-13
- Results first posted
- 2013-12-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase | 12 months | Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day). |
| Secondary | Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase | 12 months | Clinical remission was defined as a score of 0 for rectal bleeding and stool frequency. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day). |
| Secondary | Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase | 12 months | Relapse was defined in the Maintenance Phase as the need for alternative treatment for UC (including surgery); subjects were classified as having a relapse if they had withdrawn from the study due to a lack of efficacy. |
| Secondary | Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase | 12 months | Subjects with mucosal healing were defined as subjects who had an endoscopy score \<=1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). |
| Secondary | Improvement in Rectal Bleeding Score During the Acute Phase | 3 and 8 weeks | Improvement was defined as at least a 1-point reduction in the rectal bleeding score from baseline at each assessment point. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). |
| Secondary | Improvement in Stool Frequency Symptoms During the Acute Phase | 3 and 8 weeks | Improvement was defined as at least a 1-point reduction in the stool frequency score from baseline at each assessment point. Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day). |
| Secondary | Percentage of Subjects in Complete Remission at Week 8 of Acute Phase | 8 Weeks | Complete (clinical and endoscopic) remission was defined as a modified UC-DAI \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day). |
| Secondary | Percentage of Subjects in Partial Remission at Week 8 of Acute Phase | 8 weeks | Partial remission was defined as a modified UC-DAI \<=3 with a combined stool frequency and rectal bleeding score of \<=1 and not in complete remission. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase | 12 months | Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase | 12 months | Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment. | percentage of subjects | NUMBER |
| SECONDARY | Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase | 12 months | Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase | 12 months | Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment. | percentage of subjects | NUMBER |
| SECONDARY | Improvement in Rectal Bleeding Score During the Acute Phase | 3 and 8 weeks | Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product. | percentage of subjects | NUMBER |
| SECONDARY | Improvement in Stool Frequency Symptoms During the Acute Phase | 3 and 8 weeks | Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects in Complete Remission at Week 8 of Acute Phase | 8 Weeks | Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects in Partial Remission at Week 8 of Acute Phase | 8 weeks | Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product. | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase | MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase) | 47.8 | percentage of subjects | ||
| Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase | MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase) | 26.0 | percentage of subjects | ||
| Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase | MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase) | 58.8 | percentage of subjects | ||
| Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase | MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase) | 40.4 | percentage of subjects | ||
| Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase | MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase) | 6.0 | percentage of subjects | ||
| Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase | MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase) | 10.5 | percentage of subjects | ||
| Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase | MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase) | 76.4 | percentage of subjects | ||
| Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase | MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase) | 63.5 | percentage of subjects | ||
| Improvement in Rectal Bleeding Score During the Acute Phase | MMX Mesalamine/ Mesalazine | Week 3 | 42.4 | percentage of subjects | |
| Improvement in Rectal Bleeding Score During the Acute Phase | MMX Mesalamine/ Mesalazine | Week 8 | 59.8 | percentage of subjects |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Acute Phase | STARTED | MMX Mesalamine/ Mesalazine | 722 | |
| Acute Phase | COMPLETED | MMX Mesalamine/ Mesalazine | 639 | |
| Acute Phase | NOT COMPLETED | MMX Mesalamine/ Mesalazine | 83 | |
| Maintenance Phase | STARTED | MMX Mesalamine/ Mesalazine | 469 | |
| Maintenance Phase | COMPLETED | MMX Mesalamine/ Mesalazine | 373 | |
| Maintenance Phase | NOT COMPLETED | MMX Mesalamine/ Mesalazine | 96 |
Source ClinicalTrials.gov
Adverse events68
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 | Colitis ulcerative | Gastrointestinal disorders | MMX Mesalamine/ Mesalazine (Acute Phase) | 10 | 717 | |
| other | Colitis ulcerative | Gastrointestinal disorders | MMX Mesalamine/ Mesalazine (Maintenance Phase) | 43 | 461 | |
| other | Drug ineffective | General disorders | MMX Mesalamine/ Mesalazine (Acute Phase) | 50 | 717 | |
| other | Drug ineffective | General disorders | MMX Mesalamine/ Mesalazine (Maintenance Phase) | 22 | 461 | |
| serious | Myocardial infarction | Cardiac disorders | MMX Mesalamine/ Mesalazine (Acute Phase) | 1 | 717 | |
| serious | Myocardial infarction | Cardiac disorders | MMX Mesalamine/ Mesalazine (Maintenance Phase) | 0 | 461 | |
| serious | Colitis ulcerative | Gastrointestinal disorders | MMX Mesalamine/ Mesalazine (Acute Phase) | 2 | 717 | |
| serious | Colitis ulcerative | Gastrointestinal disorders | MMX Mesalamine/ Mesalazine (Maintenance Phase) | 1 | 461 | |
| serious | Pancreatitis acute | Gastrointestinal disorders | MMX Mesalamine/ Mesalazine (Acute Phase) | 1 | 717 | |
| serious | Pancreatitis acute | Gastrointestinal disorders | MMX Mesalamine/ Mesalazine (Maintenance Phase) | 0 | 461 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MMX Mesalamine/ Mesalazine (Acute Phase) | ||
| Total, all-cause mortality | MMX Mesalamine/ Mesalazine (Maintenance Phase) | ||
| Total, other adverse events | MMX Mesalamine/ Mesalazine (Acute Phase) | 60 | 717 |
| Total, other adverse events | MMX Mesalamine/ Mesalazine (Maintenance Phase) | 65 | 461 |
| Total, serious adverse events | MMX Mesalamine/ Mesalazine (Acute Phase) | 13 | 717 |
| Total, serious adverse events | MMX Mesalamine/ Mesalazine (Maintenance Phase) | 14 | 461 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MMX Mesalamine/ Mesalazine (Acute Phase) vs MMX Mesalamine/ Mesalazine (Maintenance Phase): serious adverse events |
Source Trial comparisons
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/NCT01124149
GET https://conductscience.org/api/trials/v1/NCT01124149/events?page=2