Trial Outcomes & Findings for Effect of Secretin in Functional Dyspepsia and Healthy Subjects (NCT NCT03617861)
NCT ID: NCT03617861
Last Updated: 2020-06-11
Results Overview
Thirty (30) minutes after ingesting the meal of 300 mL radio-labeled Ensure drink, an additional Ensure drink was ingested at a constant rate of 30 mL/min until maximum tolerated volume was reached.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
60 minutes
Results posted on
2020-06-11
Participant Flow
Participant milestones
| Measure |
Healthy Controls: Secretin Then Placebo
Healthy subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 2.
|
Healthy Controls: Placebo Then Secretin
Healthy subjects first receive placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.
|
Functional Dyspepsia: Secretin Then Placebo
Functional Dyspepsia subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 2.
|
Functional Dyspepsia: Placebo Then Secretin
Functional Dyspepsia subjects first receive placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.
|
|---|---|---|---|---|
|
First Intervention (1 Day)
STARTED
|
5
|
5
|
5
|
5
|
|
First Intervention (1 Day)
COMPLETED
|
5
|
5
|
5
|
5
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (1 to 4 Weeks)
STARTED
|
5
|
5
|
5
|
5
|
|
Washout (1 to 4 Weeks)
COMPLETED
|
5
|
5
|
5
|
5
|
|
Washout (1 to 4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
5
|
5
|
5
|
5
|
|
Second Intervention (1 Day)
COMPLETED
|
5
|
5
|
4
|
5
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Healthy Controls: Secretin Then Placebo
Healthy subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 2.
|
Healthy Controls: Placebo Then Secretin
Healthy subjects first receive placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.
|
Functional Dyspepsia: Secretin Then Placebo
Functional Dyspepsia subjects first receive human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 2.
|
Functional Dyspepsia: Placebo Then Secretin
Functional Dyspepsia subjects first receive placebo treatment (normal saline matching Secretin dose) via IV over 1 min on Visit Day 1. After a 1 to 4 week washout period, they received the human Secretin 0.2 mcg/kg via IV over 1 min on Visit Day 2.
|
|---|---|---|---|---|
|
Second Intervention (1 Day)
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Effect of Secretin in Functional Dyspepsia and Healthy Subjects
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=10 Participants
Healthy controls were randomly assigned to secretin or placebo allocation before treatment. After a 1 to 4 week washout period, they received the alternate treatment from that administered on Day 1.
|
Functional Dyspepsia
n=10 Participants
Functional Dyspepsia subjects were randomly assigned to secretin or placebo allocation before treatment. After a 1 to 4 week washout period, they received the alternate treatment from that administered on Day 1.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.0 years
n=99 Participants
|
50.5 years
n=107 Participants
|
47.0 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 60 minutesThirty (30) minutes after ingesting the meal of 300 mL radio-labeled Ensure drink, an additional Ensure drink was ingested at a constant rate of 30 mL/min until maximum tolerated volume was reached.
Outcome measures
| Measure |
Healthy Controls: Secretin
n=10 Participants
Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
|
Healthy Controls: Placebo
n=10 Participants
Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
|
Functional Dyspepsia: Secretin
n=10 Participants
Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
|
Functional Dyspepsia: Placebo
n=10 Participants
Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
|
|---|---|---|---|---|
|
Maximum Satiation
|
892.5 mL
Interval 892.5 to 1011.0
|
951.75 mL
Interval 892.5 to 1129.5
|
655.5 mL
Interval 537.0 to 774.0
|
892.5 mL
Interval 655.5 to 1011.0
|
PRIMARY outcome
Timeframe: BaselineGastric fasting volume was measured prior to a meal of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).
Outcome measures
| Measure |
Healthy Controls: Secretin
n=10 Participants
Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
|
Healthy Controls: Placebo
n=10 Participants
Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
|
Functional Dyspepsia: Secretin
n=10 Participants
Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
|
Functional Dyspepsia: Placebo
n=10 Participants
Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
|
|---|---|---|---|---|
|
Fasting Gastric Volume
|
171.28 mL
Interval 146.17 to 189.39
|
152.96 mL
Interval 145.5 to 161.04
|
227 mL
Interval 186.7 to 251.2
|
210.2 mL
Interval 179.38 to 240.54
|
PRIMARY outcome
Timeframe: 15 minutesPostprandial volume was measured 15 minutes after ingestion of 300 mL standardized radio-labeled Ensure drink using an intravenous injection of Technetium Tc-99m pertechnetate and noninvasive single photon emission-computed tomography (SPECT).
Outcome measures
| Measure |
Healthy Controls: Secretin
n=10 Participants
Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
|
Healthy Controls: Placebo
n=10 Participants
Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
|
Functional Dyspepsia: Secretin
n=10 Participants
Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
|
Functional Dyspepsia: Placebo
n=10 Participants
Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
|
|---|---|---|---|---|
|
Postprandial Volume
|
435.85 mL
Interval 384.7 to 647.71
|
457.43 mL
Interval 329.39 to 495.01
|
593.80 mL
Interval 557.85 to 637.9
|
582.36 mL
Interval 546.51 to 631.33
|
PRIMARY outcome
Timeframe: Baseline, 30 minutesThe change in gastric accommodation was measured in mL using the difference between the fasting gastric volume and the postprandial volume.
Outcome measures
| Measure |
Healthy Controls: Secretin
n=10 Participants
Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
|
Healthy Controls: Placebo
n=10 Participants
Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
|
Functional Dyspepsia: Secretin
n=10 Participants
Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
|
Functional Dyspepsia: Placebo
n=10 Participants
Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
|
|---|---|---|---|---|
|
Change in Gastric Accommodation
|
270.44 mL
Interval 221.97 to 468.01
|
271.01 mL
Interval 194.74 to 343.62
|
378.6 mL
Interval 339.42 to 404.18
|
370.2 mL
Interval 339.09 to 382.06
|
PRIMARY outcome
Timeframe: 30 minutesGastric emptying was measured via scintigraphy 30 minutes after ingestion of 300 mL of radio-labeled Ensure drink and was reported as the percentage of the radio-labeled liquid meal emptied from the stomach.
Outcome measures
| Measure |
Healthy Controls: Secretin
n=10 Participants
Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
|
Healthy Controls: Placebo
n=10 Participants
Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
|
Functional Dyspepsia: Secretin
n=10 Participants
Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
|
Functional Dyspepsia: Placebo
n=10 Participants
Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
|
|---|---|---|---|---|
|
Gastric Emptying
|
7.0 percentage of gastric emptying
Interval 0.0 to 10.0
|
19.0 percentage of gastric emptying
Interval 15.0 to 26.0
|
0 percentage of gastric emptying
Interval 0.0 to 0.0
|
8.0 percentage of gastric emptying
Interval 2.0 to 9.0
|
PRIMARY outcome
Timeframe: Baseline, 30 minutes30 minutes after ingesting a meal of 300 mL of Ensure drink postprandial symptoms of fullness, nausea, bloating and pain were measured using a horizontal visual analog scales from 0 to 100, where 0 was 'none' and 100 was 'worst ever'.
Outcome measures
| Measure |
Healthy Controls: Secretin
n=10 Participants
Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
|
Healthy Controls: Placebo
n=10 Participants
Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
|
Functional Dyspepsia: Secretin
n=10 Participants
Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min on either the first or second study visit day.
|
Functional Dyspepsia: Placebo
n=10 Participants
Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
|
|---|---|---|---|---|
|
Change in Postprandial Symptoms
Nausea
|
1.5 score on a scale
Interval 0.0 to 3.0
|
1.5 score on a scale
Interval 0.0 to 2.0
|
10 score on a scale
Interval 8.0 to 28.0
|
4 score on a scale
Interval 4.0 to 11.0
|
|
Change in Postprandial Symptoms
Fullness
|
7 score on a scale
Interval 3.0 to 10.0
|
4.5 score on a scale
Interval 2.0 to 6.0
|
31 score on a scale
Interval 22.0 to 42.0
|
11 score on a scale
Interval 5.0 to 33.0
|
|
Change in Postprandial Symptoms
Bloating
|
1.5 score on a scale
Interval 0.0 to 7.0
|
1.5 score on a scale
Interval 0.0 to 3.0
|
24 score on a scale
Interval 6.0 to 34.0
|
26 score on a scale
Interval 8.0 to 28.0
|
|
Change in Postprandial Symptoms
Abdominal pain
|
1 score on a scale
Interval 0.0 to 2.0
|
2 score on a scale
Interval 0.0 to 3.0
|
5 score on a scale
Interval 2.0 to 19.0
|
10 score on a scale
Interval 5.0 to 21.0
|
Adverse Events
Healthy Controls: Secretin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Functional Dyspepsia: Secretin
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Functional Dyspepsia: Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Controls: Secretin
n=10 participants at risk
Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min.
|
Healthy Controls: Placebo
n=10 participants at risk
Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min.
|
Functional Dyspepsia: Secretin
n=10 participants at risk
Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min.
|
Functional Dyspepsia: Placebo
n=10 participants at risk
Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
10.0%
1/10 • Number of events 1 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
10.0%
1/10 • Number of events 1 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
10.0%
1/10 • Number of events 1 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
50.0%
5/10 • Number of events 5 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
40.0%
4/10 • Number of events 4 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
20.0%
2/10 • Number of events 2 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
30.0%
3/10 • Number of events 3 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
|
General disorders
Abdominal pain
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
20.0%
2/10 • Number of events 2 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
10.0%
1/10 • Number of events 1 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
|
Gastrointestinal disorders
Postprandial fullness
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
10.0%
1/10 • Number of events 1 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
10.0%
1/10 • Number of events 1 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
|
General disorders
Headache
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
10.0%
1/10 • Number of events 1 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
30.0%
3/10 • Number of events 3 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
|
General disorders
Dizziness
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
10.0%
1/10 • Number of events 1 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
0.00%
0/10 • Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place