Trial Outcomes & Findings for Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis (NCT NCT00075023)
NCT ID: NCT00075023
Last Updated: 2015-11-04
Results Overview
Mean percentage change in total surface area of oral ulceration
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
baseline to 4 weeks
Results posted on
2015-11-04
Participant Flow
Participant milestones
| Measure |
Thalidomide Gel
Thalidomide Gel
|
Placebo
Placebo Gel
|
|---|---|---|
|
Pilot Study
STARTED
|
5
|
5
|
|
Pilot Study
COMPLETED
|
3
|
3
|
|
Pilot Study
NOT COMPLETED
|
2
|
2
|
|
Part Two
STARTED
|
0
|
0
|
|
Part Two
COMPLETED
|
0
|
0
|
|
Part Two
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Thalidomide Gel
Thalidomide Gel
|
Placebo
Placebo Gel
|
|---|---|---|
|
Pilot Study
Physician Decision
|
1
|
2
|
|
Pilot Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Effectiveness of Topical Thalidomide to Treat Chronic Graft-Versus-Host-Disease Related Stomatitis
Baseline characteristics by cohort
| Measure |
Thalidomide Gel
n=5 Participants
Thalidomide Gel
|
Placebo
n=5 Participants
Placebo Gel
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
27-60 yrs
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=93 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=93 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline to 4 weeksMean percentage change in total surface area of oral ulceration
Outcome measures
| Measure |
Thalidomide Gel
n=3 Participants
Thalidomide Gel
|
Placebo
n=3 Participants
Placebo Gel
|
|---|---|---|
|
Mean Percentage Change in Total Surface Area of Oral Ulceration.
|
-66 percentage change
Standard Deviation NA
Not available due to unavailable records
|
-59 percentage change
Standard Deviation NA
Not available due to unavailable records
|
Adverse Events
Thalidomide Gel
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Adverse Events for All Participants
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Thalidomide Gel
n=5 participants at risk
Thalidomide Gel
|
Placebo
n=5 participants at risk
Placebo Gel
|
Adverse Events for All Participants
n=10 participants at risk
These are adverse events for participants as reported to the DSMB, without information related to treatment arm
|
|---|---|---|---|
|
General disorders
Increase in oral pain
|
20.0%
1/5
|
20.0%
1/5
|
—
0/0
|
|
Social circumstances
Spouse pregnancy
|
0.00%
0/5
|
20.0%
1/5
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
—
0/0
|
—
0/0
|
20.0%
2/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on exertion
|
—
0/0
|
—
0/0
|
10.0%
1/10
|
|
General disorders
thrush
|
—
0/0
|
—
0/0
|
20.0%
2/10
|
|
General disorders
Oral pain
|
—
0/0
|
—
0/0
|
20.0%
2/10
|
|
General disorders
Sore throat
|
—
0/0
|
—
0/0
|
20.0%
2/10
|
|
General disorders
headache
|
—
0/0
|
—
0/0
|
10.0%
1/10
|
|
General disorders
tired
|
—
0/0
|
—
0/0
|
10.0%
1/10
|
|
General disorders
peripheral neuropathy
|
—
0/0
|
—
0/0
|
10.0%
1/10
|
|
Gastrointestinal disorders
loss of appetite
|
—
0/0
|
—
0/0
|
10.0%
1/10
|
|
General disorders
somnolence
|
—
0/0
|
—
0/0
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
rash
|
—
0/0
|
—
0/0
|
10.0%
1/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place