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Effect of Secretin in Functional Dyspepsia and Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03617861
Recruitment Status : Completed
First Posted : August 7, 2018
Results First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Michael Camilleri, MD, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Dyspepsia
Healthy
Interventions Drug: Human Secretin
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Controls: Secretin Then Placebo Healthy Controls: Placebo Then Secretin Functional Dyspepsia: Secretin Then Placebo Functional Dyspepsia: Placebo Then Secretin
Hide Arm/Group Description 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 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 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 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.
Period Title: First Intervention (1 Day)
Started 5 5 5 5
Completed 5 5 5 5
Not Completed 0 0 0 0
Period Title: Washout (1 to 4 Weeks)
Started 5 5 5 5
Completed 5 5 5 5
Not Completed 0 0 0 0
Period Title: Second Intervention (1 Day)
Started 5 5 5 5
Completed 5 5 4 5
Not Completed 0 0 1 0
Reason Not Completed
Adverse Event             0             0             1             0
Arm/Group Title Healthy Controls Functional Dyspepsia Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
45.0
(38.0 to 49.0)
50.5
(42.0 to 55.0)
47.0
(40.0 to 52.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
8
  80.0%
7
  70.0%
15
  75.0%
Male
2
  20.0%
3
  30.0%
5
  25.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
10
 100.0%
8
  80.0%
18
  90.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
  20.0%
2
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Maximum Satiation
Hide Description 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.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Controls: Secretin Healthy Controls: Placebo Functional Dyspepsia: Secretin Functional Dyspepsia: Placebo
Hide Arm/Group Description:
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 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 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 subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
Overall Number of Participants Analyzed 10 10 10 10
Median (Inter-Quartile Range)
Unit of Measure: mL
892.5
(892.5 to 1011)
951.75
(892.5 to 1129.5)
655.5
(537 to 774)
892.5
(655.5 to 1011)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo
Comments Healthy Controls Secretin vs Healthy Controls Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Healthy Controls vs Functional Dyspepsia
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0574
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Fasting Gastric Volume
Hide Description Gastric 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Controls: Secretin Healthy Controls: Placebo Functional Dyspepsia: Secretin Functional Dyspepsia: Placebo
Hide Arm/Group Description:
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 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 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 subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
Overall Number of Participants Analyzed 10 10 10 10
Median (Inter-Quartile Range)
Unit of Measure: mL
171.28
(146.17 to 189.39)
152.96
(145.5 to 161.04)
227
(186.7 to 251.2)
210.2
(179.38 to 240.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo
Comments Healthy Controls Secretin vs Healthy Controls Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Healthy Controls vs Functional Dyspepsia
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1451
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Postprandial Volume
Hide Description Postprandial 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).
Time Frame 15 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Controls: Secretin Healthy Controls: Placebo Functional Dyspepsia: Secretin Functional Dyspepsia: Placebo
Hide Arm/Group Description:
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 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 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 subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
Overall Number of Participants Analyzed 10 10 10 10
Median (Inter-Quartile Range)
Unit of Measure: mL
435.85
(384.70 to 647.71)
457.43
(329.39 to 495.01)
593.80
(557.85 to 637.90)
582.36
(546.51 to 631.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo
Comments Healthy Controls Secretin vs Healthy Controls Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Healthy Controls vs Functional Dyspepsia
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4233
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Primary Outcome
Title Change in Gastric Accommodation
Hide Description The change in gastric accommodation was measured in mL using the difference between the fasting gastric volume and the postprandial volume.
Time Frame Baseline, 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Controls: Secretin Healthy Controls: Placebo Functional Dyspepsia: Secretin Functional Dyspepsia: Placebo
Hide Arm/Group Description:
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 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 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 subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
Overall Number of Participants Analyzed 10 10 10 10
Median (Inter-Quartile Range)
Unit of Measure: mL
270.44
(221.97 to 468.01)
271.01
(194.74 to 343.62)
378.6
(339.42 to 404.18)
370.2
(339.09 to 382.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo
Comments Healthy Controls Secretin vs Healthy Controls Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Healthy Controls vs Functional Dyspepsia
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3891
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Primary Outcome
Title Gastric Emptying
Hide Description Gastric 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.
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Controls: Secretin Healthy Controls: Placebo Functional Dyspepsia: Secretin Functional Dyspepsia: Placebo
Hide Arm/Group Description:
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 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 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 subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
Overall Number of Participants Analyzed 10 10 10 10
Median (Inter-Quartile Range)
Unit of Measure: percentage of gastric emptying
7.0
(0 to 10.0)
19.0
(15.0 to 26.0)
0
(0 to 0)
8.0
(2.0 to 9.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo
Comments Healthy Secretin vs Healthy Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Healthy vs Functional Dyspepsia
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0355
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Primary Outcome
Title Change in Postprandial Symptoms
Hide Description 30 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'.
Time Frame Baseline, 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Controls: Secretin Healthy Controls: Placebo Functional Dyspepsia: Secretin Functional Dyspepsia: Placebo
Hide Arm/Group Description:
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 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 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 subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min on either the first or second study visit day.
Overall Number of Participants Analyzed 10 10 10 10
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
Nausea
1.5
(0 to 3)
1.5
(0 to 2)
10
(8 to 28)
4
(4 to 11)
Fullness
7
(3 to 10)
4.5
(2 to 6)
31
(22 to 42)
11
(5 to 33)
Bloating
1.5
(0 to 7)
1.5
(0 to 3)
24
(6 to 34)
26
(8 to 28)
Abdominal pain
1
(0 to 2)
2
(0 to 3)
5
(2 to 19)
10
(5 to 21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo
Comments Nausea: Healthy Controls Secretin vs Healthy Controls Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Nausea: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Nausea: Healthy Controls vs Functional Dyspepsia
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo
Comments Fullness: Healthy Controls Secretin vs Healthy Controls Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Fullness: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Fullness: Healthy Controls vs Functional Dyspepsia
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo
Comments Bloating: Healthy Controls Secretin vs Healthy Controls Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Bloating Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Bloating: Healthy Controls vs Functional Dyspepsia
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0330
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo
Comments Abdominal Pain: Healthy Controls Secretin vs Healthy Controls Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Abdominal Pain: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Healthy Controls: Secretin, Healthy Controls: Placebo, Functional Dyspepsia: Secretin, Functional Dyspepsia: Placebo
Comments Abdominal Pain: Healthy Controls vs Functional Dyspepsia
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2375
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame Adverse events will be collected on each patient for each of the two individual study days, over a total duration of approximately one year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Controls: Secretin Healthy Controls: Placebo Functional Dyspepsia: Secretin Functional Dyspepsia: Placebo
Hide Arm/Group Description Healthy controls who received human Secretin 0.2 mcg/kg via IV over 1 min. Healthy controls who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min. Functional Dyspepsia subjects who received human Secretin 0.2 mcg/kg via IV over 1 min. Functional Dyspepsia subjects who received placebo treatment (normal saline matching Secretin dose) via IV over 1 min.
All-Cause Mortality
Healthy Controls: Secretin Healthy Controls: Placebo Functional Dyspepsia: Secretin Functional Dyspepsia: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
Healthy Controls: Secretin Healthy Controls: Placebo Functional Dyspepsia: Secretin Functional Dyspepsia: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Controls: Secretin Healthy Controls: Placebo Functional Dyspepsia: Secretin Functional Dyspepsia: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/10 (10.00%)      10/10 (100.00%)      10/10 (100.00%)    
Gastrointestinal disorders         
Vomiting   0/10 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1 1/10 (10.00%)  1
Nausea   0/10 (0.00%)  0 0/10 (0.00%)  0 5/10 (50.00%)  5 4/10 (40.00%)  4
Diarrhea   0/10 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  2 3/10 (30.00%)  3
Postprandial fullness   0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1
General disorders         
Abdominal pain   0/10 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  2 1/10 (10.00%)  1
Headache   0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 3/10 (30.00%)  3
Dizziness   0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Camilleri, MD
Organization: Mayo Clinic
Phone: 507-266-2305
EMail: camilleri.michael@mayo.edu
Layout table for additonal information
Responsible Party: Michael Camilleri, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03617861    
Other Study ID Numbers: 18-003744
R01DK115950 ( U.S. NIH Grant/Contract )
R01DK122280 ( U.S. NIH Grant/Contract )
UL1TR002377 ( U.S. NIH Grant/Contract )
First Submitted: July 16, 2018
First Posted: August 7, 2018
Results First Submitted: May 15, 2020
Results First Posted: June 11, 2020
Last Update Posted: June 11, 2020