Trial · NCT00073021
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
NCT00073021, Phase 3, Completed, Warner Chilcott; results first posted 2011-07-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis. Trials, record NCT00073021. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00073021
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
- NCT number
- NCT00073021
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 386 participants, actual
- Lead sponsor
- Warner Chilcott
- Conditions
- Ulcerative Colitis
- Interventions
- Asacol 800 mg (mesalamine), Asacol 400 mg (mesalamine)
- First posted
- 2003-11-17
- Last updated
- 2015-06-29
- Results first posted
- 2011-07-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population | 6 Weeks | Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment \[stool frequency, rectal bleeding, PFA, sigmoidoscopy\] and no worsening in any other clinical assessments) |
| Secondary | Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population | 6 weeks | UCDAI - sum of clinical assessment scores (stool frequency score \[0=normal, 1=1-2 stools \> normal/day, 2=3-4 stools \> normal/day, 3=5 or more stools \> normal/day\], rectal bleeding score \[0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed and PGA score \[0=quiescent disease, 1=mild, 2=moderate, 3=severe\]) and sigmoidoscopy score \[0=normal, 1=mild, 2=moderate, 3=severe\] |
| Secondary | Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population | 6 Weeks | Rectal Bleeding - 0=no blood seen, 1=streaks of blood w/stool less than half of the time, 2=obvious blood w/stool most of the time, 3=blood alone passed Sigmoidoscopy Assessment Score - 0=normal (intact vascular pattern, no friability or granularity), 1=mild (erythema, diminished or absent vascular markings; mild granularity; friability), 2=moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations) 3=severe (spontaneous bleeding, ulcerations) |
| Secondary | Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population | 6 Weeks | Sigmoidoscopy Assessment Score (0=normal intact vascular pattern, no friability or granularity, 1=mild erythema; diminished or absent vascular markings; mild granularity; friability, 2=moderate marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations, 3=severe spontaneous bleeding, ulcerations) |
| Secondary | Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6 | 6 Weeks | 0=Normal stool frequency per day, 1=1-2 stools greater than normal per day, 2=3-4 stools greater than normal per day, 3=5 or more stools greater than normal per day |
| Secondary | Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6 | 6 Weeks | Rectal Bleeding (0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed) |
| Secondary | Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6 | 6 Weeks | PFA - 0=generally well, 1=fair, 2=poor, 3=terrible |
| Secondary | Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6 | 6 Weeks | PGA -Physician's Global Assessment - 0=quiescent disease (all parameters 0), 1=mild disease (parameters mostly 1's) 2=moderate (parameters mostly 2's), 3=severe (parameters mostly 3's) \[parameters: combination of stool frequency, rectal bleeding, PFA \& sigmoidoscopy findings\] If scoring equal default to physician judgement. |
| Secondary | Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients | 3 Weeks | IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32 - 224 - higher score better. |
| Secondary | Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients | 6 Weeks | IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32-224 - higher score better. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population | 6 Weeks | ITT Population with Moderate Disease \[PGA = 2\] at Baseline | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population | 6 weeks | ITT Population with Moderate Disease \[PGA = 2\] at Baseline. | Scores on a Scale | MEAN |
| SECONDARY | Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population | 6 Weeks | ITT Patients with Moderate Disease \[PGA=2\] at Baseline. Percentage of patients whose rectal bleeding AND sigmoidoscopy scores BOTH improved from baseline at Week 6 | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population | 6 Weeks | ITT Population with Moderate Disease \[PGA=2\] at Baseline | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6 | 6 Weeks | ITT Patients with Moderate Disease \[PGA=2\] at Baseline | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6 | 6 Weeks | ITT Population with Moderate Disease \[PGA=2\] at Baseline | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6 | 6 Weeks | ITT Population with Moderate Disease \[PGA=2\] at Baseline | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6 | 6 Weeks | ITT Population with Moderate Disease \[PGA=2\] at Baseline | Percentage of Participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients | 3 Weeks | All Randomized Patients with Moderate Disease\[PGA=2\] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social. | Scores on a Scale | MEAN |
| SECONDARY | Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients | 6 Weeks | All Randomized Patients with Moderate Disease \[PGA=2\] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social. | Scores on a Scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population | Asacol 2.4 g/Day | 59.2 | Percentage of Participants | ||
| Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population | Asacol 4.8 g/Day | 71.8 | Percentage of Participants | ||
| Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population | Asacol 2.4 g/Day | -3.2 | Standard Error 0.27 | Scores on a Scale | |
| Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population | Asacol 4.8 g/Day | -3.7 | Standard Error 0.27 | Scores on a Scale | |
| Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population | Asacol 2.4 g/Day | 59.8 | Percentage of Participants | ||
| Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population | Asacol 4.8 g/Day | 63.6 | Percentage of Participants | ||
| Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population | Asacol 2.4 g/Day | 69.0 | Percentage of Participants | ||
| Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population | Asacol 4.8 g/Day | 75.2 | Percentage of Participants | ||
| Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6 | Asacol 2.4 g/Day | 71.3 | Percentage of Participants | ||
| Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6 | Asacol 4.8 g/Day | 74.0 | Percentage of Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Asacol 2.4 g/Day | 139 | |
| Overall Study | STARTED | Asacol 4.8 g/Day | 129 | |
| Overall Study | COMPLETED | Asacol 2.4 g/Day | 113 | |
| Overall Study | COMPLETED | Asacol 4.8 g/Day | 113 | |
| Overall Study | NOT COMPLETED | Asacol 2.4 g/Day | 26 | |
| Overall Study | NOT COMPLETED | Asacol 4.8 g/Day | 16 |
Source ClinicalTrials.gov
Adverse events54
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 | Headache | Nervous system disorders | Asacol 2.4 g/Day | 15 | 195 | |
| other | Headache | Nervous system disorders | Asacol 4.8 g/Day | 16 | 191 | |
| other | Pain, Abdominal | Gastrointestinal disorders | Asacol 2.4 g/Day | 11 | 195 | |
| other | Pain, Abdominal | Gastrointestinal disorders | Asacol 4.8 g/Day | 7 | 191 | |
| other | Infection | Infections and infestations | Asacol 2.4 g/Day | 5 | 195 | |
| other | Infection | Infections and infestations | Asacol 4.8 g/Day | 9 | 191 | |
| other | Rhinitis | Respiratory, thoracic and mediastinal disorders | Asacol 2.4 g/Day | 7 | 195 | |
| other | Rhinitis | Respiratory, thoracic and mediastinal disorders | Asacol 4.8 g/Day | 1 | 191 | |
| other | Diarrhea | Gastrointestinal disorders | Asacol 2.4 g/Day | 6 | 195 | |
| other | Diarrhea | Gastrointestinal disorders | Asacol 4.8 g/Day | 8 | 191 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Asacol 2.4 g/Day | ||
| Total, all-cause mortality | Asacol 4.8 g/Day | ||
| Total, other adverse events | Asacol 2.4 g/Day | 72 | 195 |
| Total, other adverse events | Asacol 4.8 g/Day | 81 | 191 |
| Total, serious adverse events | Asacol 2.4 g/Day | 4 | 139 |
| Total, serious adverse events | Asacol 4.8 g/Day | 1 | 129 |
Source ClinicalTrials.gov
Papers2
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 |
|---|
| Asacol 2.4 g/Day vs Asacol 4.8 g/Day: 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/NCT00073021
GET https://conductscience.org/api/trials/v1/NCT00073021/results?page=2