Secretin Infusion for Pain Due to Chronic Pancreatitis

What Was Tested

The trial (phase 1, phase 2) is built around Secretin for chronic pain: fibromyalgia & crps.

It had 1 arm (groups): human secretin (other).

The registry classes the interventions as drug.

More on the Plan

12 patients will be enrolled in this study.

The diagnosis of CP will be made by the PI based on standard clinical, radiographic and/or biochemical criteria.

Patients must be taking prescribed opioid analgesics for the specific treatment of CP at the time of study enrollment.

Only patients between the ages of 18-70 and capable of providing informed consent will be considered eligible for the study.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, between the ages of 18-70 years old. Documented chronic pancreatitis as determined by CT scan, endoscopic ultrasound, MRCP and/or pancreatic function tests. Negative serum pregnancy within 72 hours of secretin administration. Use of opioid analgesics for chronic pain from CP. Willing and able to sign written informed consent.

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: male or female \<18 or \>70 years of age; abnormal serum amylase and/or lipase indicative of acute pancreatitis within 30 days of study enrollment; exhibiting signs and/or symptoms of an episode of acute pancreatitis.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Secretin study: the chronic pain: fibromyalgia & crps participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-12 with completion listed for 2011-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): VAS Score at Baseline, Days 1, 2, 3, 4, 7, 30 (time frame: Baseline, Days 1, 2, 3, 4, 7, 30). Opiate Use at Baseline, Days 4 and 30 (time frame: Baseline, Day 4, Day 30). Quality of Life at Baseline, Day 4 and Day 30 (time frame: Baseline, Day 4, Day 30).

It also tracked 2 secondary outcomes, for example Number of Participants With Serious Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Secretin in 12 people with chronic pain: fibromyalgia & crps.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Secretin compound page, Chronic pain: fibromyalgia & CRPS research.