Trial · NCT00151892
Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
NCT00151892, Phase 3, Completed, Shire; results first posted 2010-09-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis. Trials, record NCT00151892. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00151892
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
- NCT number
- NCT00151892
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 829 participants, actual
- Lead sponsor
- Shire
- Conditions
- Ulcerative Colitis
- Interventions
- SPD476, Asacol
- First posted
- 2005-09-09
- Last updated
- 2021-06-14
- Other registries' IDs
- eudract:2004-004184-29
- Results first posted
- 2010-09-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months | 6 Months | Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal \[intact vascular pattern; no friability or granulation\], 1 = mild \[erythema; decreased vascular pattern; minimal granularity\], 2 = moderate \[marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations\], 3 = severe \[ulceration; spontaneous bleeding\]. |
| Secondary | Withdrawal Due to Relapse of UC | Over 6 Months | Relapse is defined as withdrawal from the study due to lack of efficacy. |
| Secondary | Endoscopic Remission of UC With No or Mild Symptoms at 6 Months | 6 Months | Endoscopic remission with no or mild symptoms is defined as an endoscopy score of less than or equal to 1 and a combined symptom score (stool frequency plus rectal bleeding) of less than or equal to 1. 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 | Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months | Baseline and 6 months | The modified UCDAI 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. |
| Secondary | Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score | 6 Months | Quality of life (QoL) was assessed using the SIBDQ. SIBDQ total score is calculated from the sum of 10 questions. Each question is scored on a scale from 1 (poor QoL) to 7 (good QoL) with total scores ranging from 10 to 70. Higher scores indicate better QoL. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months | 6 Months | Per Protocol Population (PP) defined as all subjects who either completed the study or withdrew for reasons related to efficacy or AEs and who were deemed to be protocol-compliant. | percent of participants | NUMBER |
| SECONDARY | Withdrawal Due to Relapse of UC | Over 6 Months | PP | percent of participants | NUMBER |
| SECONDARY | Endoscopic Remission of UC With No or Mild Symptoms at 6 Months | 6 Months | PP | percent of participants | NUMBER |
| SECONDARY | Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months | Baseline and 6 months | PP | Units on a scale | MEAN |
| SECONDARY | Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score | 6 Months | Intent to treat (ITT) population defined as all randomized subjects who received at least 1 dose of investigational product. Analysis includes patients who completed an SIBDQ questionnaire at 6 months. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months | SPD476 | 83.7 | percent of participants | ||
| Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months | Asacol | 81.5 | percent of participants | ||
| Withdrawal Due to Relapse of UC | SPD476 | 12.8 | percent of participants | ||
| Withdrawal Due to Relapse of UC | Asacol | 14.6 | percent of participants | ||
| Endoscopic Remission of UC With No or Mild Symptoms at 6 Months | SPD476 | 79.0 | percent of participants | ||
| Endoscopic Remission of UC With No or Mild Symptoms at 6 Months | Asacol | 75.6 | percent of participants | ||
| Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months | SPD476 | 0.061 | Standard Deviation 1.1516 | Units on a scale | |
| Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months | Asacol | 0.059 | Standard Deviation 1.2394 | Units on a scale | |
| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score | SPD476 | 59.523 | Standard Deviation 8.7582 | Units on a scale | |
| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score | Asacol | 59.664 | Standard Deviation 7.7440 | Units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SPD476 | 416 | |
| Overall Study | STARTED | Asacol | 413 | |
| Overall Study | COMPLETED | SPD476 | 340 | |
| Overall Study | COMPLETED | Asacol | 330 | |
| Overall Study | NOT COMPLETED | SPD476 | 76 | |
| Overall Study | NOT COMPLETED | Asacol | 83 |
Source ClinicalTrials.gov
Adverse events20
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 | Colitis | Gastrointestinal disorders | SPD476 | 1 | 415 | |
| serious | Colitis | Gastrointestinal disorders | Asacol | 0 | 411 | |
| serious | Colitis ulcerative | Gastrointestinal disorders | SPD476 | 1 | 415 | |
| serious | Colitis ulcerative | Gastrointestinal disorders | Asacol | 1 | 411 | |
| serious | Appendicitis | Infections and infestations | SPD476 | 1 | 415 | |
| serious | Appendicitis | Infections and infestations | Asacol | 0 | 411 | |
| serious | Bronchitis | Infections and infestations | SPD476 | 1 | 415 | |
| serious | Bronchitis | Infections and infestations | Asacol | 0 | 411 | |
| serious | Fallopian tube perforation | Injury, poisoning and procedural complications | SPD476 | 0 | 415 | |
| serious | Fallopian tube perforation | Injury, poisoning and procedural complications | Asacol | 1 | 411 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD476 | ||
| Total, all-cause mortality | Asacol | ||
| Total, other adverse events | SPD476 | 0 | 415 |
| Total, other adverse events | Asacol | 0 | 411 |
| Total, serious adverse events | SPD476 | 6 | 415 |
| Total, serious adverse events | Asacol | 3 | 411 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| SPD476 vs Asacol: 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/NCT00151892
GET https://conductscience.org/api/trials/v1/NCT00151892/registered