NCT01818570

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Asbjørn Mohr Drewes · Academic / Other
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	PPC-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.
DRUG	Placebo	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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-03-26
• Last updated: 2014-05-14

Locations

1 site across 1 country: Denmark