Trial Outcomes & Findings for A Randomized Study of Sulindac in Oral Premalignant Lesions (NCT NCT00299195)
NCT ID: NCT00299195
Last Updated: 2020-11-19
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
after 24 weeks of study drug
Results posted on
2020-11-19
Participant Flow
Participant milestones
| Measure |
Cohort 1
sulindac
sulindac: Sulindac 150 mg po bid x 24 weeks
|
Cohort 2
placebo
Placebo: Placebo bid x 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
|
Overall Study
COMPLETED
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Study of Sulindac in Oral Premalignant Lesions
Baseline characteristics by cohort
| Measure |
Cohort 1
n=30 Participants
sulindac
sulindac: Sulindac 150 mg po bid x 24 weeks
|
Cohort 2
n=33 Participants
placebo
Placebo: Placebo bid x 24 weeks
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
n=5 Participants
|
58.6 years
n=7 Participants
|
56.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after 24 weeks of study drugPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 24 weeks of study drugPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and after 24 weeksPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 4, 8, 12, 16, 20 and 24Population: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 24 weeksPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1
Serious events: 2 serious events
Other events: 13 other events
Deaths: 1 deaths
Cohort 2
Serious events: 4 serious events
Other events: 13 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Cohort 1
n=30 participants at risk
sulindac
sulindac: Sulindac 150 mg po bid x 24 weeks
|
Cohort 2
n=33 participants at risk
placebo
Placebo: Placebo bid x 24 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal, other
|
3.3%
1/30 • 2 years
|
9.1%
3/33 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
3.3%
1/30 • 2 years
|
0.00%
0/33 • 2 years
|
|
General disorders
Death not assoc w CTCAE term- Death NOS
|
0.00%
0/30 • 2 years
|
3.0%
1/33 • 2 years
|
Other adverse events
| Measure |
Cohort 1
n=30 participants at risk
sulindac
sulindac: Sulindac 150 mg po bid x 24 weeks
|
Cohort 2
n=33 participants at risk
placebo
Placebo: Placebo bid x 24 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
3.3%
1/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • 2 years
|
0.00%
0/33 • 2 years
|
|
Endocrine disorders
Endocrine, other
|
0.00%
0/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.3%
1/30 • 2 years
|
0.00%
0/33 • 2 years
|
|
Gastrointestinal disorders
Gastritis (incl bile reflux gastritis)
|
0.00%
0/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
0.00%
0/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
Injury, poisoning and procedural complications
Hemorrhage/Bleeding, other
|
0.00%
0/30 • 2 years
|
6.1%
2/33 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Inf norm ANC/gr1/2 neut-Bronchitis NOS
|
0.00%
0/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
Gastrointestinal disorders
Inf norm ANC/gr1/2 neut-Gingivitis(oral-gums)
|
3.3%
1/30 • 2 years
|
0.00%
0/33 • 2 years
|
|
Immune system disorders
Lymphatics - Other (specify)
|
0.00%
0/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
Gastrointestinal disorders
Mucositis (Clin exam)- Oral cavity
|
3.3%
1/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
Eye disorders
Ocular/Visual - Other (specify)
|
3.3%
1/30 • 2 years
|
0.00%
0/33 • 2 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
3.3%
1/30 • 2 years
|
0.00%
0/33 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
0.00%
0/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
Nervous system disorders
Pain - Head/headache
|
3.3%
1/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
3.3%
1/30 • 2 years
|
0.00%
0/33 • 2 years
|
|
Gastrointestinal disorders
Pain - Oral cavity
|
0.00%
0/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
General disorders
Pain - Other (specify)
|
6.7%
2/30 • 2 years
|
0.00%
0/33 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulm/upp respiratory - Other (spec)
|
0.00%
0/30 • 2 years
|
3.0%
1/33 • 2 years
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
3.3%
1/30 • 2 years
|
0.00%
0/33 • 2 years
|
Additional Information
Dr. Jay Boyle, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-2906
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place