Trial Outcomes & Findings for A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis (NCT NCT02692391)
NCT ID: NCT02692391
Last Updated: 2021-04-22
Results Overview
SIRS is a simple clinical score, ranging from 0-4, that utilizes objective, routine clinical parameters (body temperature, heart rate, respiratory rate or arterial carbon dioxide tension and white blood count) that directly reflect the underlying inflammatory response. A lower change in SIRS score (negative number) indicates a better outcome (less inflammation).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
42 participants
Primary outcome timeframe
The change in the SIRS score (48 hours - baseline)
Results posted on
2021-04-22
Participant Flow
Participant milestones
| Measure |
Placebo
6 doses, Q8hrs for a total period of 48 hours
Placebo: Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin
|
Indomethacin Suppository
Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)
Indomethacin: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
18
|
|
Overall Study
COMPLETED
|
24
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis
Baseline characteristics by cohort
| Measure |
Placebo
n=24 Participants
6 doses, Q8hrs for a total period of 48 hours
Placebo: Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin
|
Indomethacin Suppository
n=18 Participants
Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)
Indomethacin: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
n=5 Participants
|
50.8 years
n=7 Participants
|
50.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 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
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 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
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
BMI, continuous
|
31.7 kg/m^2
n=5 Participants
|
27.8 kg/m^2
n=7 Participants
|
30 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: The change in the SIRS score (48 hours - baseline)SIRS is a simple clinical score, ranging from 0-4, that utilizes objective, routine clinical parameters (body temperature, heart rate, respiratory rate or arterial carbon dioxide tension and white blood count) that directly reflect the underlying inflammatory response. A lower change in SIRS score (negative number) indicates a better outcome (less inflammation).
Outcome measures
| Measure |
Placebo
n=24 Participants
6 doses, Q8hrs for a total period of 48 hours
Placebo: Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin
|
Indomethacin Suppository
n=18 Participants
Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)
Indomethacin: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours.
|
|---|---|---|
|
Systemic Inflammatory Response Syndrome (SIRS) Score
|
-0.96 score on a scale
Standard Deviation 0.81
|
-1 score on a scale
Standard Deviation 1.24
|
PRIMARY outcome
Timeframe: 48 hoursCRP levels at 48 hours after enrollment minus CRP levels at enrollment (baseline). A negative number indicates a better outcome (less inflammation).
Outcome measures
| Measure |
Placebo
n=24 Participants
6 doses, Q8hrs for a total period of 48 hours
Placebo: Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin
|
Indomethacin Suppository
n=18 Participants
Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)
Indomethacin: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours.
|
|---|---|---|
|
C-Reactive Protein (CRP) Levels.
|
-1.43 mg/dL
Standard Deviation 8.73
|
-2.08 mg/dL
Standard Deviation 12.55
|
SECONDARY outcome
Timeframe: 7 daysIncluding respiratory, renal and cardiovascular failures defined as modified Marshal score of equal and greater than 2. The minimum and maximum values in the modified Marshal score for each organ failure range from 0 to 4 with a higher value representing worse outcomes.
Outcome measures
| Measure |
Placebo
n=24 Participants
6 doses, Q8hrs for a total period of 48 hours
Placebo: Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin
|
Indomethacin Suppository
n=18 Participants
Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)
Indomethacin: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours.
|
|---|---|---|
|
Number of Participants Who Development of Organ Failure
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 monthEnrolled subjects that died. A death indicates a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
6 doses, Q8hrs for a total period of 48 hours
Placebo: Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin
|
Indomethacin Suppository
n=18 Participants
Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)
Indomethacin: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours.
|
|---|---|---|
|
Mortality
|
1 Participants
|
0 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Indomethacin Suppository
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=24 participants at risk
6 doses, Q8hrs for a total period of 48 hours
Placebo: Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin
|
Indomethacin Suppository
n=18 participants at risk
Loading dose :100mg Maintenance dose: 50 mg, Q8hrs for a total period of 48 hours (5 doses)
Indomethacin: Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours.
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
4.2%
1/24 • Number of events 1 • 1 month
|
0.00%
0/18 • 1 month
|
|
Gastrointestinal disorders
GI Bleed
|
4.2%
1/24 • Number of events 1 • 1 month
|
0.00%
0/18 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place