Trial · NCT00545103
Prevention of Recurrence of Diverticulitis
NCT00545103, Phase 3, Completed, Shire; results first posted 2012-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prevention of Recurrence of Diverticulitis. Trials, record NCT00545103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00545103
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prevention of Recurrence of Diverticulitis
- NCT number
- NCT00545103
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 592 participants, actual
- Lead sponsor
- Shire
- Conditions
- Diverticulitis
- Interventions
- SPD476, MMX™ mesalazine, 1.2g extended release tablet, SPD476, MMX™ mesalazine, 2.4g extended release tablet, SPD476, MMX™ mesalazine, 4.8g extended release tablet, Placebo
- First posted
- 2007-10-17
- Last updated
- 2021-06-11
- Other registries' IDs
- eudract:2007-004896-20
- Results first posted
- 2012-12-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Subjects Without Recurrence of Diverticulitis | up to 104 Weeks | Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (\>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences. |
| Secondary | Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis | up to 104 weeks | CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening \>5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences. |
| Secondary | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | up to 104 Weeks | A positive CT scan was defined as a CT scan that showed bowel wall thickening (\>5 mm) and/or fat stranding as read by the central reader. |
| Secondary | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | up to 104 weeks | A negative CT scan was defined as a CT scan that did not show bowel wall thickening (\>5 mm) and/or fat stranding as read by the central reader. |
| Secondary | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | up to 104 weeks | A positive CT scan was defined as a CT scan that showed bowel wall thickening (\>5 mm) and/or fat stranding as read by the central reader. |
| Secondary | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | up to 104 weeks | A negative CT scan was defined as a CT scan that did not show bowel wall thickening (\>5 mm) and/or fat stranding as read by the central reader. |
| Secondary | Percent of Subjects Requiring Surgery for Diverticulitis | up to 104 Weeks |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Subjects Without Recurrence of Diverticulitis | up to 104 Weeks | Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product. | percentage of subjects | NUMBER |
| SECONDARY | Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis | up to 104 weeks | Full Analysis Set | percentage of subjects | NUMBER |
| SECONDARY | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | up to 104 Weeks | Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects. | Number of CT Scans | NUMBER |
| SECONDARY | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | up to 104 weeks | Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects. | Number of CT Scans | NUMBER |
| SECONDARY | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | up to 104 weeks | Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects. | Number of CT Scans | NUMBER |
| SECONDARY | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | up to 104 weeks | Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects. | Number of CT Scans | NUMBER |
| SECONDARY | Percent of Subjects Requiring Surgery for Diverticulitis | up to 104 Weeks | Full Analysis Set | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Subjects Without Recurrence of Diverticulitis | SPD476 (1.2 g) | 62.8 | percentage of subjects | ||
| Percent of Subjects Without Recurrence of Diverticulitis | SPD476 (2.4 g) | 59.2 | percentage of subjects | ||
| Percent of Subjects Without Recurrence of Diverticulitis | SPD476 (4.8 g) | 69.1 | percentage of subjects | ||
| Percent of Subjects Without Recurrence of Diverticulitis | Placebo | 67.6 | percentage of subjects | ||
| Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis | SPD476 (1.2 g) | 62.8 | percentage of subjects | ||
| Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis | SPD476 (2.4 g) | 59.2 | percentage of subjects | ||
| Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis | SPD476 (4.8 g) | 69.1 | percentage of subjects | ||
| Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis | Placebo | 66.9 | percentage of subjects | ||
| Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | SPD476 (1.2 g) | Positive | 49 | Number of CT Scans | |
| Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | SPD476 (2.4 g) | Positive | 45 | Number of CT Scans |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SPD476 (1.2 g) | 148 | |
| Overall Study | STARTED | SPD476 (2.4 g) | 148 | |
| Overall Study | STARTED | SPD476 (4.8 g) | 150 | |
| Overall Study | STARTED | Placebo | 146 | |
| Overall Study | COMPLETED | SPD476 (1.2 g) | 73 | |
| Overall Study | COMPLETED | SPD476 (2.4 g) | 70 | |
| Overall Study | COMPLETED | SPD476 (4.8 g) | 74 | |
| Overall Study | COMPLETED | Placebo | 76 | |
| Overall Study | NOT COMPLETED | SPD476 (1.2 g) | 75 | |
| Overall Study | NOT COMPLETED | SPD476 (2.4 g) | 78 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events308
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 | Abdominal pain | Gastrointestinal disorders | SPD476 (1.2 g) | 19 | 148 | |
| other | Abdominal pain | Gastrointestinal disorders | SPD476 (2.4 g) | 19 | 147 | |
| other | Abdominal pain | Gastrointestinal disorders | SPD476 (4.8 g) | 15 | 149 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 12 | 142 | |
| other | Diarrhea | Gastrointestinal disorders | SPD476 (1.2 g) | 15 | 148 | |
| other | Diarrhea | Gastrointestinal disorders | SPD476 (2.4 g) | 15 | 147 | |
| other | Diarrhea | Gastrointestinal disorders | SPD476 (4.8 g) | 18 | 149 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 12 | 142 | |
| other | Nausea | Gastrointestinal disorders | SPD476 (1.2 g) | 5 | 148 | |
| other | Nausea | Gastrointestinal disorders | SPD476 (2.4 g) | 8 | 147 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD476 (1.2 g) | ||
| Total, all-cause mortality | SPD476 (2.4 g) | ||
| Total, all-cause mortality | SPD476 (4.8 g) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | SPD476 (1.2 g) | 108 | 148 |
| Total, other adverse events | SPD476 (2.4 g) | 111 | 147 |
| Total, other adverse events | SPD476 (4.8 g) | 110 | 149 |
| Total, other adverse events | Placebo | 105 | 142 |
| Total, serious adverse events | SPD476 (1.2 g) | 9 | 148 |
| Total, serious adverse events | SPD476 (2.4 g) | 13 | 147 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25038431 | 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 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/NCT00545103
GET https://conductscience.org/api/trials/v1/NCT00545103/results?page=2