Trial Outcomes & Findings for Trial of Indomethacin in Chronic Pancreatitis (NCT NCT04207060)
NCT ID: NCT04207060
Last Updated: 2024-09-04
Results Overview
Mean change in PGE2 concentrations in pancreas fluid before and after intervention
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline, 28 days
Results posted on
2024-09-04
Participant Flow
Participant milestones
| Measure |
Indomethacin
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.
Indomethacin: One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
Placebo
Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days.
Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.
Placebo: One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
|
Overall Study
COMPLETED
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Indomethacin
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.
Indomethacin: One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
Placebo
Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days.
Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.
Placebo: One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Trial of Indomethacin in Chronic Pancreatitis
Baseline characteristics by cohort
| Measure |
Indomethacin
n=13 Participants
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.
Indomethacin: One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
Placebo
n=14 Participants
Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days.
Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.
Placebo: One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 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
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Baseline PGE2 Level
|
812.4 pg/ml
STANDARD_DEVIATION 581.4 • n=5 Participants
|
991.6 pg/ml
STANDARD_DEVIATION 1000.3 • n=7 Participants
|
905.3 pg/ml
STANDARD_DEVIATION 790.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 28 daysMean change in PGE2 concentrations in pancreas fluid before and after intervention
Outcome measures
| Measure |
Indomethacin
n=13 Participants
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.
Indomethacin: One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
Placebo
n=14 Participants
Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days.
Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.
Placebo: One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
|---|---|---|
|
Change in Prostaglandin E2 (PGE2) Concentrations
|
-457.7 pg/ml
Standard Deviation 489.8
|
-840.4 pg/ml
Standard Deviation 865.6
|
SECONDARY outcome
Timeframe: Baseline, 28 daysMeasured using the self reported Brief Pain Inventory questionnaire. The pain interference subscale includes 7 items which each utilize a 11-point scale from 0-10, with 10 representing the worst outcome (highest level of pain). The scores from the 7 items are summed to create a total score. Thus, the total score can range from 0-70. The total pain interference score at baseline was then subtracted from the total pain interference score at 28 days to calculate the change in pain interference score.
Outcome measures
| Measure |
Indomethacin
n=13 Participants
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.
Indomethacin: One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
Placebo
n=14 Participants
Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days.
Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.
Placebo: One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
|---|---|---|
|
Changes in Pain Interference Score
|
-2.9 score on a scale
Standard Deviation 3.6
|
-0.4 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline, 28 daysMeasured using the self reported PROMIS-10 instrument. The PROMIS-10 instrument includes 4 items for mental health, which each have 1-5 scale, with 5 representing the worst outcome. T-scores are then calculated from the raw scores. A mean T-score of 50 represents average health with a standard deviation of 10. Higher scores denote a worse outcome. The mean T-score at baseline was then subtracted from the mean T-score at 28 days to derive the change in mental quality of life..
Outcome measures
| Measure |
Indomethacin
n=13 Participants
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.
Indomethacin: One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
Placebo
n=14 Participants
Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days.
Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.
Placebo: One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
|---|---|---|
|
Change in Quality of Life (Mental Health)
|
-3.8 T-score
Standard Deviation 10
|
0.1 T-score
Standard Deviation 6
|
SECONDARY outcome
Timeframe: Baseline, 28 daysAssessed using the Brief Pain Inventory (BPI) scale. The pain composite score includes 4 questions from the BPI, each of which is scored on a 0-10 scale with 10 representing the worst outcome (highest level of pain) and 0 representing the best outcome (no pain). The 4 questions assess 1) worst pain, 2) least pain, 3) average pain, and 4) current pain. The mean score of the responses to these 4 questions is calculated to derive the pain composite score. Thus, the pain composite score will also range from 0-10. The mean pain composite score at baseline was then subtracted from the mean pain composite score at 28 days to calculate the change in pain composite score.
Outcome measures
| Measure |
Indomethacin
n=13 Participants
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.
Indomethacin: One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
Placebo
n=14 Participants
Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days.
Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.
Placebo: One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
|---|---|---|
|
Change in Pain Composite Score
|
-1.3 score on a scale
Standard Deviation 1.5
|
-0.5 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, 28 daysQuality of life measured using the self reported PROMIS-10 instrument. The PROMIS-10 instrument includes 4 items for physical health, which each have a 1-5 scale, with 5 representing the worst outcome. T-scores are then calculated from the raw scores. A T-score of 50 indicates the population mean with a standard deviation of 10. Higher T-scores represent worse outcomes. The mean T-score at baseline was then subtracted from the mean T-score at 28 days to derive the change in physical quality of life.
Outcome measures
| Measure |
Indomethacin
n=13 Participants
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.
Indomethacin: One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
Placebo
n=14 Participants
Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days.
Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.
Placebo: One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
|---|---|---|
|
Change in Quality of Life (Physical Health)
|
1.6 T-score
Standard Deviation 5.4
|
1.4 T-score
Standard Deviation 5.2
|
Adverse Events
Indomethacin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Indomethacin
n=13 participants at risk
The study intervention is oral indomethacin. Indomethacin is an FDA approved, commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Commercially available indomethacin will be utilized in this study. Subjects randomized to the indomethacin arm will take one capsule of 50 mg of Indomethacin orally twice a day for 28 days. Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medications.
Indomethacin: One capsule of 50 mg of indomethacin will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
Placebo
n=14 participants at risk
Participants in both study arms will receive study medication, one capsule orally twice a day for 28 days. Those in the placebo arm will take placebo capsules (one capsule) twice a day for a total of 28 days.
Participants will be advised not to make up missed doses. They will be advised to take a dose of study medication on the morning of their follow-up endoscopy, 2 hours prior to their scheduled procedure time, with a sip of water. At the time of follow-up endoscopy they will return any unused study medication.
Placebo: One capsule of lactose not containing active study drug will be taken orally twice a day for a total of 28 days.
Endoscopy for Pancreatic Function Testing: All subjects in the study (regardless of which treatment arm they are randomized to) will undergo an upper endoscopy during which they will receive an endoscopic pancreatic function test. An upper endoscopy will be performed during the baseline visit and at the follow-up visit at day 28 of the treatment (2 endoscopies total per each subject). Specifically, during the upper endoscopy, secretin will be administered intravenously at a weight-based dose of 0.2 mcg/kg over 1 minute. Fluid will be aspirated from the duodenum through the endoscope from 0-10 minutes and 10-20 minutes following secretin administration. The collected fluid will then be sent to the laboratory for analysis.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea and Vomiting
|
7.7%
1/13 • Number of events 1 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
7.1%
1/14 • Number of events 1 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
0.00%
0/14 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
0.00%
0/13 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
7.1%
1/14 • Number of events 1 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
|
Gastrointestinal disorders
Bloating
|
7.7%
1/13 • Number of events 1 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
0.00%
0/14 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
|
Endocrine disorders
Hot Flashes
|
0.00%
0/13 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
7.1%
1/14 • Number of events 1 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
0.00%
0/14 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
|
Nervous system disorders
Drowsiness
|
0.00%
0/13 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
7.1%
1/14 • Number of events 1 • Adverse Events were collected from initiation of the study intervention to 30 days after completion of the intervention. The follow-up time points were specifically at 7 days, 14 days, 21 days and 58 days following study intervention initiation.
Adverse events and serious adverse events were defined as defined by clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place