Trial · NCT00505778
A Comparison of Once a Day Dose Compared to 2 Doses/Day
NCT00505778, Phase 3, Completed, Warner Chilcott; results first posted 2011-05-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Comparison of Once a Day Dose Compared to 2 Doses/Day. Trials, record NCT00505778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00505778
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of Once a Day Dose Compared to 2 Doses/Day
- NCT number
- NCT00505778
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,027 participants, actual
- Lead sponsor
- Warner Chilcott
- Conditions
- Ulcerative Colitis
- Interventions
- Mesalamine Once-Daily, Mesalamine Twice-Daily
- First posted
- 2007-07-23
- Last updated
- 2013-04-22
- Results first posted
- 2011-05-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) | 6 months | Remission defined as SCCAI \<5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation). |
| Secondary | Percentage of Patients Remaining in Remission at Month 3, ITT Population | 3 months | Remission defined as SCCAI \< 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation). |
| Secondary | Percentage of Patients Remaining in Remission at Month 12, ITT Population | 12 months | Remission defined as SCCAI score \< 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation). |
| Secondary | Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population | 6 months | Relapse/flare is defined as SCCAI \>= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation). |
| Secondary | Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6 | 6 months | MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45. |
| Secondary | Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6 | 6 months | Is your ulcerative colitis in remission (not active)? Y/N |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) | 6 months | ITT Population | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Patients Remaining in Remission at Month 3, ITT Population | 3 months | ITT Population | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Patients Remaining in Remission at Month 12, ITT Population | 12 months | ITT Population | Percentage of Participants | NUMBER |
| SECONDARY | Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population | 6 months | ITT Population | Participants | NUMBER |
| SECONDARY | Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6 | 6 months | ITT Population | MARS Score | MEAN |
| SECONDARY | Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6 | 6 months | ITT Population | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) | Mesalamine Once-Daily | 90.5 | Percentage of Participants | ||
| Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) | Mesalamine Twice-Daily | 91.8 | Percentage of Participants | ||
| Percentage of Patients Remaining in Remission at Month 3, ITT Population | Mesalamine Once-Daily | 94.8 | Percentage of Participants | ||
| Percentage of Patients Remaining in Remission at Month 3, ITT Population | Mesalamine Twice-Daily | 95.6 | Percentage of Participants | ||
| Percentage of Patients Remaining in Remission at Month 12, ITT Population | Mesalamine Once-Daily | 85.4 | Percentage of Participants | ||
| Percentage of Patients Remaining in Remission at Month 12, ITT Population | Mesalamine Twice-Daily | 85.4 | Percentage of Participants | ||
| Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population | Mesalamine Once-Daily | 45 | Participants | ||
| Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population | Mesalamine Twice-Daily | 39 | Participants | ||
| Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6 | Mesalamine Once-Daily | 42.3 | Standard Error 0.23 | MARS Score | |
| Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6 | Mesalamine Twice-Daily | 41.8 | Standard Error 0.24 | MARS Score |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mesalamine Once-Daily | 514 | |
| Overall Study | STARTED | Mesalamine Twice-Daily | 513 | |
| Overall Study | Intent to Treat (ITT) Population | Mesalamine Once-Daily | 512 | |
| Overall Study | Intent to Treat (ITT) Population | Mesalamine Twice-Daily | 511 | |
| Overall Study | COMPLETED | Mesalamine Once-Daily | 380 | |
| Overall Study | COMPLETED | Mesalamine Twice-Daily | 378 | |
| Overall Study | NOT COMPLETED | Mesalamine Once-Daily | 134 | |
| Overall Study | NOT COMPLETED | Mesalamine Twice-Daily | 135 |
Source ClinicalTrials.gov
Adverse events72
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 |
|---|---|---|---|---|---|---|
| serious | Abdominal Pain | Gastrointestinal disorders | Mesalamine Once-Daily | 0 | 512 | |
| serious | Abdominal Pain | Gastrointestinal disorders | Mesalamine Twice-Daily | 1 | 511 | |
| serious | Ascites | Gastrointestinal disorders | Mesalamine Once-Daily | 0 | 512 | |
| serious | Ascites | Gastrointestinal disorders | Mesalamine Twice-Daily | 1 | 511 | |
| serious | Constipation | Gastrointestinal disorders | Mesalamine Once-Daily | 0 | 512 | |
| serious | Constipation | Gastrointestinal disorders | Mesalamine Twice-Daily | 1 | 511 | |
| serious | Rectal Haemorrhage | Gastrointestinal disorders | Mesalamine Once-Daily | 0 | 512 | |
| serious | Rectal Haemorrhage | Gastrointestinal disorders | Mesalamine Twice-Daily | 1 | 511 | |
| serious | Anal fistula | Gastrointestinal disorders | Mesalamine Once-Daily | 1 | 512 | |
| serious | Anal fistula | Gastrointestinal disorders | Mesalamine Twice-Daily | 0 | 511 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mesalamine Once-Daily | ||
| Total, all-cause mortality | Mesalamine Twice-Daily | ||
| Total, other adverse events | Mesalamine Once-Daily | 0 | 512 |
| Total, other adverse events | Mesalamine Twice-Daily | 0 | 511 |
| Total, serious adverse events | Mesalamine Once-Daily | 18 | 512 |
| Total, serious adverse events | Mesalamine Twice-Daily | 9 | 511 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20064514 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mesalamine Once-Daily vs Mesalamine Twice-Daily: Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population | Trial comparisons |
| Mesalamine Once-Daily vs Mesalamine Twice-Daily: serious adverse events | 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/NCT00505778
GET https://conductscience.org/api/trials/v1/NCT00505778/events?page=2