A Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus

A Single-center, Randomized, Double-blind, Cross-over Trial in Healthy Volunteers Investigating the Local Efficacy and Safety of a Single Intra-luminal Administration of PPC-5650 on Reflux Pain and Hyperalgesia During Multimodal Stimulation of the Esophagus

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01818570

Enrollment

Registered

2013-03-26

Start date

2013-01-31

Completion date

2014-01-31

Last updated

2014-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux, Gastroesophageal Reflux Disease

Keywords

Gastroesophageal Reflux

Brief summary

The purpose of this trial is to evaluate the effect of a single PPC-5650 dose in a human pain model including multimodal (mechanical, thermal, electrical, chemical) stimulations of the esophagus.

Interventions

DRUGPPC-5650

A dose of 2.5 mg PPC-5650 in a 100 ml solution will be administered to the esophagus with an infusion rate of 7ml/min in one out of three visit days.

DRUGPlacebo

A 100 ml placebo solution will be administered to the esophagus with an infusion rate of 7ml/min in one out of three visit days.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Signed informed consent before any study specific procedures * Able to read and understand Danish. * Healthy i.e. no history of chronic or recurrent pain rewarding diseases * Able to co-operate and tolerate the experimental procedures (as assessed in the training visit) * No over the counter medication 24h before the three visits * No medications in the study period * BMI 18.5-35.0 * Caucasian * No symptoms of Gastroesophageal reflux disease * All men must use a safe method of contraception during the study period

Exclusion criteria

* Any clinically relevant abnormal values from the laboratory tests on hematology, clinical chemistry, and/or urine analyses, as judged by the investigator. * Participation in any other clinical trial within three months prior to the training day. * Alcohol or drug abuse. * Mental illnesses * Allergic to the active ingredient in the investigational medicinal product

Design outcomes

Primary

Measure	Time frame
Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical)	4 hours

Secondary

Measure	Time frame
Number of observed adverse effects (safety profile) and changes in size of referred pain area	1 month

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026