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

NCT01818570 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-05-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Asbjørn Mohr Drewes

    lead OTHER

Principal Investigators

  • Asbjørn M Drewes, Professor · Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01818570 on ClinicalTrials.gov