Trial · NCT00217022
Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
NCT00217022, Phase 2, Phase 3, Terminated, Mayo Clinic; results first posted 2012-04-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis. Trials, record NCT00217022. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00217022
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
- NCT number
- NCT00217022
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 16 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Lymphocytic Colitis, Diarrhea
- Interventions
- Placebo, Budesonide
- First posted
- 2005-09-22
- Last updated
- 2021-11-02
- Results first posted
- 2012-04-12
- Limitations and caveats
- Study closed early, because of low enrollment. Primary physician for patients with lymphocytic colitis would prescribe Budesonide off label for them. Subjects not interested in placebo trial.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks | Three out of last four weeks that the subject was on the study | Subjects were asked if they felt they had satisfactory control of their diarrhea, along with the number of stools and type of stool (loose, water, formed, hard) the patient were experiencing. The rating of "satisfactory control" of diarrhea was therefore a partially subjective measure. This outcome measure was to be recorded for three out of the last four weeks that a subject was on the study; subjects were to take part in the study approximately 8 weeks. |
| Secondary | Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies | Baseline (day 1 of study) and at eight weeks (approximately) | The histopathology scoring system included epithelial damage, lamina propria cellularity and intraepithelial lymphocytosis, each scored on a four point scale ("normal" (0), "mildly increased" (1), "moderately increased" (2), "severely increased" (3)). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks | Three out of last four weeks that the subject was on the study | participants | NUMBER | |
| SECONDARY | Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies | Baseline (day 1 of study) and at eight weeks (approximately) | Only 8 of the subjects on the budesonide arm returned for the biopsy, so only those subjects on that arm were analyzed for this outcome measure. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks | Budesonide | 11 | participants | ||
| Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks | Placebo | 4 | participants | ||
| Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies | Budesonide | 7 | participants | ||
| Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies | Placebo | 1 | participants |
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 | Budesonide | 12 | |
| Overall Study | STARTED | Placebo | 4 | |
| Overall Study | COMPLETED | Budesonide | 11 | |
| Overall Study | COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Budesonide | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Budesonide | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Budesonide | 0 | 11 |
| Total, other adverse events | Placebo | 0 | 4 |
| Total, serious adverse events | Budesonide | 0 | 11 |
| Total, serious adverse events | Placebo | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1RR024150 | Mayo Clinic Center for Translational Science Activities | RIZZA, ROBERT A. | MAYO CLINIC ROCHESTER | NATIONAL CENTER FOR RESEARCH RESOURCES | 2006 to 2011 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Budesonide vs Placebo: Satisfactory Control of Diarrhea During at Least Three of the Last Four Weeks | Trial comparisons |
| Budesonide vs Placebo: Histologic Improvement in Post Treatment Colon Biopsies Compared to Baseline Biopsies | Trial comparisons |
| Budesonide vs Placebo: 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/NCT00217022
GET https://conductscience.org/api/trials/v1/NCT00217022/registered