| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| A Randomised, Double Blind Cross-over Study of Serial MRCP Following Morphine-neostigmine and Secretin Provocation in Healthy Volunteers [NCT01134848] | Phase 4 | 10 participants (Actual) | Interventional | 2009-01-31 | Completed |
| MRCP With Secretin Stimulation for the Evaluation of Pancreatic Endocrine and Exocrine Function Following Surgical Resection for Pancreatic Adenocarcinoma [NCT01094535] | | 0 participants (Actual) | Interventional | 2007-09-30 | Withdrawn(stopped due to Poor enrollment) |
| A Phase II Study to Establish the Efficacy of Synthetic Human SecretiN in Human Acute Pancreatitis (SNAP) Study [NCT03686618] | Phase 2 | 40 participants (Anticipated) | Interventional | 2018-10-01 | Recruiting |
| Effect of Secretin on Gastric Accommodation, Emptying and Post-nutrient Challenge Symptoms in Functional Dyspepsia and Healthy Subjects [NCT03617861] | Phase 1/Phase 2 | 20 participants (Actual) | Interventional | 2018-11-07 | Completed |
| Evaluation of Efficiency of Secretin-Assisted Computed Tomography Scan and Secretin-Assisted Magnetic Resonance Imaging in Improving Pancreatic Enhancement and Tumor Conspicuity: Prospective Study [NCT01371240] | Early Phase 1 | 0 participants (Actual) | Interventional | 2011-06-30 | Withdrawn(stopped due to Study never started) |
| Comparison of Secretin Enhanced MRCP to Endoscopic Pancreatic Function Testing in Diagnosing Exocrine Insufficiency in Patients Who Have Undergone Pancreas Cancer Resection [NCT01094600] | | 0 participants (Actual) | Interventional | 2012-06-30 | Withdrawn |
| Secretin Increases Glucose Uptake in Human Brown Adipose Tissue and Induces Satiation. [NCT03290846] | Phase 2/Phase 3 | 23 participants (Actual) | Interventional | 2016-08-02 | Completed |
| Study to Assess Pancreatic Blood Flow at Rest and During Stimulation Using Magnetic Resonance Imaging (fMRI) in Patients With Chronic Pancreatitis [NCT02458118] | Phase 1/Phase 2 | 15 participants (Anticipated) | Interventional | 2012-06-30 | Recruiting |
| Aspiration of Duodenopancreatic Juice After Secretin Stimulation (ADPJ-secr-) vs Endoscopic Aspiration (EUS-FNA) for Molecular Analysis of Intraductal Papillary Mucinous Intraductal Neoplasia (IPMN). [NCT05914077] | Phase 3 | 140 participants (Anticipated) | Interventional | 2023-09-13 | Recruiting |
| Optical and Biochemical Biomarkers in Early Pancreatic Cancer Significance: A Prospective Study [NCT03404661] | | 346 participants (Actual) | Observational | 2018-01-11 | Completed |
| Magnetic Resonance Cholangiopancreatography (MRCP): A Reliable, Non Invasive Method for Staging Chronic Pancreatitis From Minimal Change Disease to the Advanced Stages in Pediatrics [NCT02869893] | | 57 participants (Actual) | Interventional | 2016-08-10 | Completed |
| Imaging Biomarkers of Pancreatic Function and Disease [NCT05659147] | Phase 4 | 195 participants (Anticipated) | Interventional | 2023-01-18 | Enrolling by invitation |
| RG1068 (Synthetic Human Secretin) Enhanced Multidetector CT Pancreatography: Evaluation of the Pancreatic Duct in Patients With Known or Suspected Chronic Pancreatitis [NCT00620919] | Phase 1 | 0 participants (Actual) | Interventional | 2008-02-29 | Terminated(stopped due to Poor patient enrollment due to logistical issues.) |
| The Cancer of the Pancreas Screening-5 CAPS5)Study [NCT02000089] | Phase 3 | 7,000 participants (Anticipated) | Interventional | 2014-01-06 | Recruiting |
| Intraductal Secretin Stimulation Test: What Is the Proper Collection Time? [NCT03263481] | | 8 participants (Actual) | Interventional | 2017-09-01 | Completed |
| Phase III Study to Demonstrate the Efficacy and Safety of RG1068 (Synthetic Human Secretin)- Enhanced Magnetic Resonance Cholangiopancreatography (MRCP) in the Evaluation of Subjects With a History of Acute or Acute Recurrent Pancreatitis [NCT00660335] | Phase 3 | 258 participants (Actual) | Interventional | 2008-03-31 | Completed |
| The Role of Secretin on the Energy Homeostasis [NCT04613700] | | 25 participants (Actual) | Interventional | 2020-03-01 | Completed |
| MRI With Secretin Enhancement to Increase Conspicuity of Pancreatic Cancer [NCT01094626] | | 0 participants (Actual) | Interventional | 2010-04-30 | Withdrawn(stopped due to Pharmaceutical company did not decide to renew contract) |
| An Open-Label, Dose Escalation, Pilot Study to Assess the Safety and Efficacy of Subcutaneous RG1068 (Synthetic Human Secretin) in Patients With Obsessive Compulsive Disorder (OCD) [NCT00216294] | Phase 2 | 16 participants | Interventional | 2005-02-28 | Completed |
| Recurrent Abdominal Pain and Exocrine Pancreatic Insufficiency [NCT04231279] | Phase 3 | 800 participants (Anticipated) | Interventional | 2020-01-31 | Not yet recruiting |
| RG1068 (Synthetic Human Secretin) Enhanced MRCP for Morphological Evaluation of the Pancreatic Duct in the Pediatric Population [NCT00621283] | Phase 1 | 0 participants (Actual) | Interventional | 2008-02-29 | Terminated(stopped due to Poor patient enrollment due to logistical issues) |
| RG1068 (Synthetic Human Secretin) Enhanced MRCP for Morphological Evaluation of the Known or Suspected Intraductal Papillary Mucinous Neoplasms of the Pancreas [NCT00621556] | Phase 1 | 2 participants (Actual) | Interventional | 2008-02-29 | Terminated(stopped due to Poor patient enrollment due to logistical issues) |
| Screening for Early Pancreatic Neoplasia [NCT00438906] | | 200 participants (Actual) | Observational | 2006-12-31 | Completed |
| Secretin Infusion for Pain Due to Chronic Pancreatitis [NCT01265875] | Phase 1/Phase 2 | 12 participants (Actual) | Interventional | 2010-12-31 | Completed |
| Evidence Based Management of Acute Biliary Pancreatitis [NCT04615702] | | 30 participants (Actual) | Observational [Patient Registry] | 2017-05-15 | Completed |
| A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Efficacy, Safety and Tolerability of RG1068 (Synthetic Human Secretin) in Children With Autism [NCT00036244] | Phase 3 | 0 participants | Interventional | 2002-04-30 | Completed |
| Multisite Controlled Secretin Trial in Autism [NCT00065962] | Phase 3 | 85 participants | Interventional | 1999-06-30 | Completed |
| A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Efficacy, Safety and Tolerability of RG1068 (Synthetic Human Secretin) in Children With Autism and Gastrointestinal Dysfunction [NCT00036231] | Phase 3 | 0 participants | Interventional | 2002-04-30 | Terminated |
| Effects of RG1068 (Secretin) on Information Processing in Schizophrenia [NCT00235274] | Phase 2 | 30 participants | Interventional | 2005-11-30 | Completed |
| The Use of Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy Volunteers [NCT01452217] | Phase 1 | 12 participants (Actual) | Interventional | 2010-09-30 | Completed |
| Secretin Infusion to Prevent Pancreatic Leaks Following Pancreatic Resection [NCT02160808] | Phase 2/Phase 3 | 170 participants (Actual) | Interventional | 2014-05-31 | Completed |
| Secretin-Stimulated MRCP as an Early Screening Modality for Pancreatic Ductal Abnormalities in Patients at High Risk for Pancreatic Adenocarcinoma: A Pilot Study [NCT01094561] | | 23 participants (Actual) | Interventional | 2006-07-31 | Completed |
| Pilot Study Using Secretin and Iodinated Intravenous Contrast and 64-Channel CT in Patients at High Risk for Pancreatic Adenocarcinoma [NCT00587132] | Phase 1/Phase 2 | 4 participants (Actual) | Interventional | 2006-11-30 | Terminated(stopped due to Lack of funding) |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.
Subjects will receive the secretin test dose just prior to the CT scan. Definitions: Evidence of Pancreatic Tumor (low-attenuation mass), Secondary Findings of Pancreatic Tumor such as dilated pancreatic duct or liver masses suggestive of liver metastases. (NCT00587132)
Timeframe: Day 1 of study
| Intervention | participants (Number) |
|---|
| New Onset Diabetes | 0 |
Number of Participants With Serious Adverse Events.
(NCT01265875)
Timeframe: 30 Days
| Intervention | participants (Number) |
|---|
| Human Secretin | 3 |
Opiate Use at Baseline, Days 4 and 30.
Daily opiate use (oral morphine equivalent). (NCT01265875)
Timeframe: Baseline, Day 4, Day 30.
| Intervention | mg/day (Mean) |
|---|
| Baseline | Day 4 | Day 30 |
|---|
| Human Secretin | 139.6 | 127.0 | 97.2 |
Quality of Life at Baseline, Day 4 and Day 30.
Sf-36 ranges from 0 to 151. Higher scores indicating worse outcomes. (NCT01265875)
Timeframe: Baseline, Day 4, Day 30.
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 4 | Day 30 |
|---|
| Human Secretin | 100.92 | 100.9 | 101.45 |
VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30.
10 point visual analog scale. 0= no pain. 10= worst possible pain. Days 1, 2, 3 were infusion days that included 5 VAS scores each day. (NCT01265875)
Timeframe: Baseline, Days 1, 2, 3, 4, 7, 30.
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 1 Pre-dose | Day 1 Dose 1 (.05mcg/kg) 100min post dose | Day 1 Dose 2 (.1mcg/kg) 100 min post dose | Day 1 Dose 3 (.2mcg/kg) 100 min post dose | Day 1 Dose 3 (.2mcg/kg) 380 min post dose | Day 2 Pre-dose | Day 2 Dose 1 (.1mcg/kg) 100min post dose | Day 2 Dose 2 (.2mcg/kg) 100min post dose | Day 2 Dose 3 (.4mcg/kg) 100min post dose | Day 2 Dose 3 (.4mcg/kg) 380min post dose | Day 3 Pre-dose | Day 3 Dose 1 (.2mcg/kg) 100min post dose | Day 3 Dose 2 (.4mcg/kg) 100min post dose | Day 3 Dose 3 (.8mcg/kg) 100min post dose | Day 3 Dose 3 (.8mcg/kg) 380min post dose | Day 4 | Day 7 | Day 30 |
|---|
| Human Secretin | 5.71 | 6.04 | 4.92 | 4.87 | 5.30 | 4.64 | 5.33 | 5.25 | 5.50 | 4.67 | 4.77 | 4.92 | 4.58 | 4.33 | 5.17 | 4.71 | 4.80 | 5.18 | 4.91 |
VAS Score at Each Administered Dose.
10 point scare from 0-10 with higher scores meaning higher levels of pain. VAS score assessed after each dose was summarized over Days 1, 2, and 3. (NCT01265875)
Timeframe: Days 1, 2, and 3.
| Intervention | units on a scale (Mean) |
|---|
| Pre-dose | .05 mcg/kg | .1 mcg/kg | .2 mcg/kg | .4 mcg/kg | .8 mcg/kg |
|---|
| Human Secretin | 6.04 | 4.92 | 5.06 | 4.92 | 4.5 | 5.36 |
Length of Hospitalization
Surrogate marker for operative success (NCT02160808)
Timeframe: Duration of study - average 30 days
| Intervention | Days (Mean) |
|---|
| Secretin | 10.3 |
| Saline | 10.2 |
Number of Participants With Biochemical Leak/Grade B Fistula/Grade C Fistula
Outcome based on revised ISGPS Guidelines which require a three day drain amylase concentration greater than 3x the normal serum amylase concentration. Biochemical leaks are the mildest for of fistula which have no clinical consequence. Grade B fistula are more severe requiring usually percutaneous drainage placement. Grade C fistula are most severe resulting in significant morbidity and/or death. (NCT02160808)
Timeframe: 3 days
| Intervention | Participants (Count of Participants) |
|---|
| Biochemical Leak | Grade B Fistula | Grade C Fistula |
|---|
| Saline | 16 | 5 | 0 |
,| Secretin | 25 | 3 | 0 |
Number of Participants With Intra-operative Intervention, Subsequent Biochemical Leak or B/C Fistula After Drug Administration
Following the administration of Secretin or Placebo intraoperatively, the surgeon will have the opportunity to evaluate the anastomosis to determine if there is ongoing leak. If there is ongoing leak, then the surgeon will be able to treat the leak intra-operatively prior to operative closure. In those patients in whom an intervention was performed, they were subsequently evaluated to determine if they developed a biochemical leak or grade B/C fistula. (NCT02160808)
Timeframe: Through completion of intra-operative intervention and subsequent biochemical leak, B/C Fistula up to 30 days post-operatively
| Intervention | Participants (Count of Participants) |
|---|
| Intervention | Subsequent Biochemical Leak | Subsequent B/C Fistula |
|---|
| Saline | 3 | 2 | 1 |
,| Secretin | 8 | 8 | 0 |
Pancreatic Stiffness as Measured by Magnetic Resonance Elastography (MRE)
Healthy controls underwent 3D MRE on a 1.5T scanner. Regions of interest for measurement of pancreatic stiffness were drawn by two blinded readers and statistical analysis were performed for comparisons between the 2 groups. (NCT02869893)
Timeframe: Single time point, pre-secretin
| Intervention | kPa (Mean) |
|---|
| Healthy Participants | 1.7 |
Total Secreted Fluid Volume as Measured by MR-PFT
"Participants underwent MR imaging prior to and following secretin administration. Pre-secretin imaging lasts approximately 20 minutes. Post-secretin images were acquired at 1 minute, 5 minutes and 15 minutes following completion of secretin injection. Pre-secretin enteric fluid volumes were subtracted from post-secretin enteric fluid volumes for each participant to determine volume secreted in response to secretin administration at each time point.~A commercially available software package determines the area of fluid signal on the MR images. The fluid signal from the pre-secretin images is then subtracted from the each post-secretin image (1, 5 and 15 minutes images) to determine the amount of fluid produced by the introduction of secretin." (NCT02869893)
Timeframe: 35 minutes (20 min pre-secretin, 15 minutes post-secretin)
| Intervention | mL (Median) |
|---|
| Healthy Participants | 79 |
Volumetric Measurement of Pancreatic Parenchymal Volume
Pancreatic parenchymal volume by manual segmentation (tracing) of pancreas contours on magnetic resonance imaging (MRI) (NCT02869893)
Timeframe: Single time point, pre-secretin
| Intervention | mL (Mean) |
|---|
| Healthy Participants | 46 |
Change in Gastric Accommodation
The change in gastric accommodation was measured in mL using the difference between the fasting gastric volume and the postprandial volume. (NCT03617861)
Timeframe: Baseline, 30 minutes
| Intervention | mL (Median) |
|---|
| Healthy Controls: Secretin | 270.44 |
| Healthy Controls: Placebo | 271.01 |
| Functional Dyspepsia: Secretin | 378.6 |
| Functional Dyspepsia: Placebo | 370.2 |
Fasting Gastric Volume
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). (NCT03617861)
Timeframe: Baseline
| Intervention | mL (Median) |
|---|
| Healthy Controls: Secretin | 171.28 |
| Healthy Controls: Placebo | 152.96 |
| Functional Dyspepsia: Secretin | 227 |
| Functional Dyspepsia: Placebo | 210.2 |
Gastric Emptying
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. (NCT03617861)
Timeframe: 30 minutes
| Intervention | percentage of gastric emptying (Median) |
|---|
| Healthy Controls: Secretin | 7.0 |
| Healthy Controls: Placebo | 19.0 |
| Functional Dyspepsia: Secretin | 0 |
| Functional Dyspepsia: Placebo | 8.0 |
Maximum Satiation
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. (NCT03617861)
Timeframe: 60 minutes
| Intervention | mL (Median) |
|---|
| Healthy Controls: Secretin | 892.5 |
| Healthy Controls: Placebo | 951.75 |
| Functional Dyspepsia: Secretin | 655.5 |
| Functional Dyspepsia: Placebo | 892.5 |
Postprandial Volume
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). (NCT03617861)
Timeframe: 15 minutes
| Intervention | mL (Median) |
|---|
| Healthy Controls: Secretin | 435.85 |
| Healthy Controls: Placebo | 457.43 |
| Functional Dyspepsia: Secretin | 593.80 |
| Functional Dyspepsia: Placebo | 582.36 |
Change in Postprandial Symptoms
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'. (NCT03617861)
Timeframe: Baseline, 30 minutes
| Intervention | score on a scale (Median) |
|---|
| Nausea | Fullness | Bloating | Abdominal pain |
|---|
| Functional Dyspepsia: Placebo | 4 | 11 | 26 | 10 |
,| Functional Dyspepsia: Secretin | 10 | 31 | 24 | 5 |
,| Healthy Controls: Placebo | 1.5 | 4.5 | 1.5 | 2 |
,| Healthy Controls: Secretin | 1.5 | 7 | 1.5 | 1 |