Trial · NCT00075023
Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis
NCT00075023, Phase 2, Terminated, National Institute of Nursing Research (NINR); results first posted 2015-11-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis. Trials, record NCT00075023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00075023
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis
- NCT number
- NCT00075023
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Conditions
- Graft-versus-Host Disease, Stomatitis
- Interventions
- Thalidomide Gel, Placebo Gel
- First posted
- 2003-12-31
- Last updated
- 2015-11-04
- Results first posted
- 2015-11-04
- Limitations and caveats
- Small sample size due to difficult enrollment
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percentage Change in Total Surface Area of Oral Ulceration. | baseline to 4 weeks | Mean percentage change in total surface area of oral ulceration |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Percentage Change in Total Surface Area of Oral Ulceration. | baseline to 4 weeks | percentage change | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percentage Change in Total Surface Area of Oral Ulceration. | Thalidomide Gel | -66 | Standard Deviation NA | percentage change | |
| Mean Percentage Change in Total Surface Area of Oral Ulceration. | Placebo | -59 | Standard Deviation NA | percentage change |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pilot Study | STARTED | Thalidomide Gel | 5 | |
| Pilot Study | STARTED | Placebo | 5 | |
| Pilot Study | COMPLETED | Thalidomide Gel | 3 | |
| Pilot Study | COMPLETED | Placebo | 3 | |
| Pilot Study | NOT COMPLETED | Thalidomide Gel | 2 | |
| Pilot Study | NOT COMPLETED | Placebo | 2 | |
| Part Two | STARTED | Thalidomide Gel | 0 | |
| Part Two | STARTED | Placebo | 0 | |
| Part Two | COMPLETED | Thalidomide Gel | 0 | |
| Part Two | COMPLETED | Placebo | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events42
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 | Increase in oral pain | General disorders | Thalidomide Gel | 1 | 5 | |
| other | Increase in oral pain | General disorders | Placebo | 1 | 5 | |
| other | Increase in oral pain | General disorders | Adverse Events for All Participants | 0 | 0 | |
| other | Spouse pregnancy | Social circumstances | Thalidomide Gel | 0 | 5 | |
| other | Spouse pregnancy | Social circumstances | Placebo | 1 | 5 | |
| other | Spouse pregnancy | Social circumstances | Adverse Events for All Participants | 0 | 0 | |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Thalidomide Gel | 1 | 5 | |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 5 | |
| other | Pneumonia | Respiratory, thoracic and mediastinal disorders | Adverse Events for All Participants | 0 | 0 | |
| other | Dyspnea on exertion | Respiratory, thoracic and mediastinal disorders | Thalidomide Gel | 0 | 0 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Thalidomide Gel | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Adverse Events for All Participants | ||
| Total, other adverse events | Thalidomide Gel | 2 | 5 |
| Total, other adverse events | Placebo | 2 | 5 |
| Total, other adverse events | Adverse Events for All Participants | 6 | 10 |
| Total, serious adverse events | Thalidomide Gel | 0 | 5 |
| Total, serious adverse events | Placebo | 0 | 5 |
| Total, serious adverse events | Adverse Events for All Participants | 0 | 0 |
Source ClinicalTrials.gov
Papers4
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 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/NCT00075023
GET https://conductscience.org/api/trials/v1/NCT00075023/events?page=2