Trial Outcomes & Findings for Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP) (NCT NCT01483144)
NCT ID: NCT01483144
Last Updated: 2021-06-08
Results Overview
Progression of disease by evaluation of FAP-related events over the course of study treatment
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
171 participants
Primary outcome timeframe
Up to 48 months from the start of treatment
Results posted on
2021-06-08
Participant Flow
Participant milestones
| Measure |
Eflornithine Plus Sulindac
Eflornithine 750 mg and Sulindac 150 mg
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
Eflornithine Plus Sulindac Placebo
Eflornithine 750 mg and Placebo
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac placebo: Sulindac placebo \[one tablet orally once a day\]
|
Sulindac Plus Eflornithine Placebo
Sulindac 150 mg and Placebo
Eflornithine Placebo: Eflornithine placebo \[three tablets orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
57
|
58
|
|
Overall Study
COMPLETED
|
41
|
44
|
43
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
15
|
Reasons for withdrawal
| Measure |
Eflornithine Plus Sulindac
Eflornithine 750 mg and Sulindac 150 mg
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
Eflornithine Plus Sulindac Placebo
Eflornithine 750 mg and Placebo
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac placebo: Sulindac placebo \[one tablet orally once a day\]
|
Sulindac Plus Eflornithine Placebo
Sulindac 150 mg and Placebo
Eflornithine Placebo: Eflornithine placebo \[three tablets orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
5
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
1
|
|
Overall Study
Protocol Violation
|
3
|
3
|
3
|
Baseline Characteristics
Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)
Baseline characteristics by cohort
| Measure |
Eflornithine Plus Sulindac
n=56 Participants
Eflornithine 750 mg and Sulindac 150 mg
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
Eflornithine Plus Sulindac Placebo
n=57 Participants
Eflornithine 750 mg and Placebo
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac placebo: Sulindac placebo \[one tablet orally once a day\]
|
Sulindac Plus Eflornithine Placebo
n=58 Participants
Sulindac 150 mg and Placebo
Eflornithine Placebo: Eflornithine placebo \[three tablets orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 13.35 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 14.76 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 13.66 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 13.88 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
42 participants
n=5 Participants
|
103 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 48 months from the start of treatmentPopulation: Intent to treat population with 171 subjects. Intent to treat population with lower GI anatomy (ower GI population) to evaluate lower GI FAP related events with 158 subjects.
Progression of disease by evaluation of FAP-related events over the course of study treatment
Outcome measures
| Measure |
Eflornithine Plus Sulindac
n=56 Participants
Eflornithine 750 mg and Sulindac 150 mg
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
Eflornithine Plus Sulindac Placebo
n=57 Participants
Eflornithine 750 mg and Placebo
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac placebo: Sulindac placebo \[one tablet orally once a day\]
|
Sulindac Plus Eflornithine Placebo
n=58 Participants
Sulindac 150 mg and Placebo
Eflornithine Placebo: Eflornithine placebo \[three tablets orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
|---|---|---|---|
|
Number of Subjects With Any FAP-related Event.
Number with FAP-related events
|
18 Participants
|
23 Participants
|
22 Participants
|
|
Number of Subjects With Any FAP-related Event.
Number with Lower GI FAP-related events
|
2 Participants
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: through month 12 assessmentGlobal assessment of change in upper GI polyp burden. These are binary outcomes derived from scores assigned by the investigator during each procedure, using a scale (-2, -1, 0, +1, +2) which corresponds, respectively, to the investigator's overall qualitative assessment of: much worse, worse, no change, improved, much improved. Summarizes the corresponding 6- and 12-month investigator change scores according to whether or not there was any positive improvement at either month 6 (compared to baseline) or at month 12 (compared to baseline or month 6), under the condition that there be no worsening at either timepoint.
Outcome measures
| Measure |
Eflornithine Plus Sulindac
n=56 Participants
Eflornithine 750 mg and Sulindac 150 mg
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
Eflornithine Plus Sulindac Placebo
n=57 Participants
Eflornithine 750 mg and Placebo
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac placebo: Sulindac placebo \[one tablet orally once a day\]
|
Sulindac Plus Eflornithine Placebo
n=58 Participants
Sulindac 150 mg and Placebo
Eflornithine Placebo: Eflornithine placebo \[three tablets orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
|---|---|---|---|
|
Improvement in Investigator Upper GI Assessment
Improved
|
11 Participants
|
10 Participants
|
10 Participants
|
|
Improvement in Investigator Upper GI Assessment
Not Improved
|
45 Participants
|
47 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: through month 12 assessmentGlobal assessment of change in lower GI polyp burden. These are binary outcomes derived from scores assigned by the investigator during each procedure, using a scale (-2, -1, 0, +1, +2) which corresponds, respectively, to the investigator's overall qualitative assessment of: much worse, worse, no change, improved, much improved. Summarizes the corresponding 6- and 12-month investigator change scores according to whether or not there was any positive improvement at either month 6 (compared to baseline) or at month 12 (compared to baseline or month 6), under the condition that there be no worsening at either timepoint.
Outcome measures
| Measure |
Eflornithine Plus Sulindac
n=56 Participants
Eflornithine 750 mg and Sulindac 150 mg
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
Eflornithine Plus Sulindac Placebo
n=57 Participants
Eflornithine 750 mg and Placebo
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac placebo: Sulindac placebo \[one tablet orally once a day\]
|
Sulindac Plus Eflornithine Placebo
n=58 Participants
Sulindac 150 mg and Placebo
Eflornithine Placebo: Eflornithine placebo \[three tablets orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
|---|---|---|---|
|
Improvement in Investigator Lower GI Assessment
Improved
|
22 Participants
|
16 Participants
|
22 Participants
|
|
Improvement in Investigator Lower GI Assessment
Not Improved
|
34 Participants
|
41 Participants
|
36 Participants
|
Adverse Events
Eflornithine Plus Sulindac
Serious events: 11 serious events
Other events: 52 other events
Deaths: 0 deaths
Eflornithine Plus Sulindac Placebo
Serious events: 14 serious events
Other events: 49 other events
Deaths: 0 deaths
Sulindac Plus Eflornithine Placebo
Serious events: 11 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eflornithine Plus Sulindac
n=56 participants at risk
Eflornithine 750 mg and Sulindac 150 mg
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
Eflornithine Plus Sulindac Placebo
n=56 participants at risk
Eflornithine 750 mg and Placebo
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac placebo: Sulindac placebo \[one tablet orally once a day\]
|
Sulindac Plus Eflornithine Placebo
n=57 participants at risk
Sulindac 150 mg and Placebo
Eflornithine Placebo: Eflornithine placebo \[three tablets orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
|---|---|---|---|
|
Renal and urinary disorders
renal failure acute
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary mass
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
small intestinal obstruction
|
3.6%
2/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
3.5%
2/57 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
abdominal pain
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
ileus
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
gastrointestinal hemorrhage
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
inguinal hernia
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
pancreatitis acute
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
rectal hemorrhage
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Hepatobiliary disorders
biliary colic
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Injury, poisoning and procedural complications
alcohol poisoning
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Injury, poisoning and procedural complications
anastomotic stenosis
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Injury, poisoning and procedural complications
post procedural hemorrhage
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Injury, poisoning and procedural complications
post operative ileus
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Injury, poisoning and procedural complications
procedural pain
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Injury, poisoning and procedural complications
seroma
|
1.8%
1/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Injury, poisoning and procedural complications
upper limb fracture
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Injury, poisoning and procedural complications
wound complication
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Injury, poisoning and procedural complications
wound dehiscence
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Musculoskeletal and connective tissue disorders
bursitis
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Musculoskeletal and connective tissue disorders
intervertebral disc protrusion
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
chronic myeloid leukaemia
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung adenocarcinoma
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
renal cell carcinoma
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
thyroid neoplasm
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Nervous system disorders
migraine
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Reproductive system and breast disorders
abortion spontaneous
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Psychiatric disorders
depression
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Psychiatric disorders
psychotic disorder
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Renal and urinary disorders
nephritis
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
Other adverse events
| Measure |
Eflornithine Plus Sulindac
n=56 participants at risk
Eflornithine 750 mg and Sulindac 150 mg
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
Eflornithine Plus Sulindac Placebo
n=56 participants at risk
Eflornithine 750 mg and Placebo
Eflornithine: Eflornithine \[250 mg tablet, three tablets (750 mg) orally once a day\]
Sulindac placebo: Sulindac placebo \[one tablet orally once a day\]
|
Sulindac Plus Eflornithine Placebo
n=57 participants at risk
Sulindac 150 mg and Placebo
Eflornithine Placebo: Eflornithine placebo \[three tablets orally once a day\]
Sulindac 150 MG: Sulindac \[one tablet orally once a day\]
|
|---|---|---|---|
|
Blood and lymphatic system disorders
iron deficiency anaemia
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Ear and labyrinth disorders
ear pain
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
7.0%
4/57 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
diarrhoea
|
12.5%
7/56 • Number of events 8 • Up to 4 years
Review of adverse events monthly
|
14.3%
8/56 • Number of events 12 • Up to 4 years
Review of adverse events monthly
|
10.5%
6/57 • Number of events 9 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
nausea
|
21.4%
12/56 • Number of events 18 • Up to 4 years
Review of adverse events monthly
|
16.1%
9/56 • Number of events 14 • Up to 4 years
Review of adverse events monthly
|
21.1%
12/57 • Number of events 21 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
abdominal pain
|
14.3%
8/56 • Number of events 13 • Up to 4 years
Review of adverse events monthly
|
7.1%
4/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
14.0%
8/57 • Number of events 10 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
vomiting
|
10.7%
6/56 • Number of events 8 • Up to 4 years
Review of adverse events monthly
|
12.5%
7/56 • Number of events 10 • Up to 4 years
Review of adverse events monthly
|
17.5%
10/57 • Number of events 23 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
abdominal pain upper
|
12.5%
7/56 • Number of events 8 • Up to 4 years
Review of adverse events monthly
|
7.1%
4/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
dyspepsia
|
3.6%
2/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
8.9%
5/56 • Number of events 5 • Up to 4 years
Review of adverse events monthly
|
8.8%
5/57 • Number of events 6 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
rectal haemorrhage
|
12.5%
7/56 • Number of events 8 • Up to 4 years
Review of adverse events monthly
|
7.1%
4/56 • Number of events 7 • Up to 4 years
Review of adverse events monthly
|
12.3%
7/57 • Number of events 8 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
haematochezia
|
10.7%
6/56 • Number of events 10 • Up to 4 years
Review of adverse events monthly
|
10.7%
6/56 • Number of events 8 • Up to 4 years
Review of adverse events monthly
|
3.5%
2/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
constipation
|
5.4%
3/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
8.9%
5/56 • Number of events 7 • Up to 4 years
Review of adverse events monthly
|
3.5%
2/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
abdominal distension
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
8.9%
5/56 • Number of events 6 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
flatulence
|
8.9%
5/56 • Number of events 5 • Up to 4 years
Review of adverse events monthly
|
5.4%
3/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
pouchitis
|
5.4%
3/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
3.5%
2/57 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
frequent bowel movements
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
5.4%
3/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
small bowel obstruction
|
5.4%
3/56 • Number of events 6 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
3.5%
2/57 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
|
Gastrointestinal disorders
gastritis erosive
|
5.4%
3/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
General disorders
fatigue
|
7.1%
4/56 • Number of events 5 • Up to 4 years
Review of adverse events monthly
|
14.3%
8/56 • Number of events 11 • Up to 4 years
Review of adverse events monthly
|
14.0%
8/57 • Number of events 9 • Up to 4 years
Review of adverse events monthly
|
|
General disorders
influenza like illness
|
8.9%
5/56 • Number of events 7 • Up to 4 years
Review of adverse events monthly
|
8.9%
5/56 • Number of events 7 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
|
General disorders
oedema peripheral
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
5.4%
3/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Immune system disorders
seasonal allergy
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
5.4%
3/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Infections and infestations
nasopharyngitis
|
10.7%
6/56 • Number of events 12 • Up to 4 years
Review of adverse events monthly
|
17.9%
10/56 • Number of events 14 • Up to 4 years
Review of adverse events monthly
|
7.0%
4/57 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
|
Infections and infestations
upper respiratory tract infection
|
14.3%
8/56 • Number of events 14 • Up to 4 years
Review of adverse events monthly
|
3.6%
2/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
14.0%
8/57 • Number of events 10 • Up to 4 years
Review of adverse events monthly
|
|
Infections and infestations
sinusitis
|
7.1%
4/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
8.9%
5/56 • Number of events 5 • Up to 4 years
Review of adverse events monthly
|
3.5%
2/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Infections and infestations
influenza
|
7.1%
4/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
5.4%
3/56 • Number of events 5 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Infections and infestations
urinary tract infection
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
7.1%
4/56 • Number of events 5 • Up to 4 years
Review of adverse events monthly
|
3.5%
2/57 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
|
Infections and infestations
bronchitis
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Infections and infestations
gastroenteritis
|
12.5%
7/56 • Number of events 9 • Up to 4 years
Review of adverse events monthly
|
7.1%
4/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
8.8%
5/57 • Number of events 6 • Up to 4 years
Review of adverse events monthly
|
|
Infections and infestations
gastroenteritis viral
|
5.4%
3/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Injury, poisoning and procedural complications
procedural pain
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
5.4%
3/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Injury, poisoning and procedural complications
contusion
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
5.4%
3/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Investigations
weight increased
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
5.4%
3/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Investigations
platelet count decreased
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
|
Metabolism and nutrition disorders
decreased appetite
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
7.1%
4/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
8.8%
5/57 • Number of events 5 • Up to 4 years
Review of adverse events monthly
|
|
Metabolism and nutrition disorders
vitamin D deficiency
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Musculoskeletal and connective tissue disorders
back pain
|
8.9%
5/56 • Number of events 8 • Up to 4 years
Review of adverse events monthly
|
8.9%
5/56 • Number of events 6 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
7.1%
4/56 • Number of events 6 • Up to 4 years
Review of adverse events monthly
|
8.9%
5/56 • Number of events 8 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
7.1%
4/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
7.1%
4/56 • Number of events 5 • Up to 4 years
Review of adverse events monthly
|
3.5%
2/57 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
5.4%
3/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Nervous system disorders
headache
|
14.3%
8/56 • Number of events 11 • Up to 4 years
Review of adverse events monthly
|
8.9%
5/56 • Number of events 6 • Up to 4 years
Review of adverse events monthly
|
19.3%
11/57 • Number of events 12 • Up to 4 years
Review of adverse events monthly
|
|
Nervous system disorders
dizziness
|
7.1%
4/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
10.7%
6/56 • Number of events 11 • Up to 4 years
Review of adverse events monthly
|
7.0%
4/57 • Number of events 6 • Up to 4 years
Review of adverse events monthly
|
|
Nervous system disorders
disturbance in attention
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Psychiatric disorders
depression
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
7.0%
4/57 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
|
Psychiatric disorders
anxiety
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
7.0%
4/57 • Number of events 6 • Up to 4 years
Review of adverse events monthly
|
|
Psychiatric disorders
insomnia
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
7.0%
4/57 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
5.4%
3/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
10.7%
6/56 • Number of events 6 • Up to 4 years
Review of adverse events monthly
|
7.0%
4/57 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
8.9%
5/56 • Number of events 6 • Up to 4 years
Review of adverse events monthly
|
8.9%
5/56 • Number of events 5 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/57 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Skin and subcutaneous tissue disorders
rash
|
10.7%
6/56 • Number of events 6 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
3.5%
2/57 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
|
Skin and subcutaneous tissue disorders
pruritus
|
5.4%
3/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
7.0%
4/57 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
|
Skin and subcutaneous tissue disorders
alopecia
|
3.6%
2/56 • Number of events 2 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
5.3%
3/57 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
|
Skin and subcutaneous tissue disorders
urticaria
|
5.4%
3/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Skin and subcutaneous tissue disorders
dry skin
|
5.4%
3/56 • Number of events 3 • Up to 4 years
Review of adverse events monthly
|
1.8%
1/56 • Number of events 1 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
|
Skin and subcutaneous tissue disorders
eczema
|
0.00%
0/56 • Up to 4 years
Review of adverse events monthly
|
5.4%
3/56 • Number of events 4 • Up to 4 years
Review of adverse events monthly
|
0.00%
0/57 • Up to 4 years
Review of adverse events monthly
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60