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

May 13, 2014 updated by: Asbjørn Mohr Drewes

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Jutland
      • Aalborg, Jutland, Denmark, 9000
        • Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo solution
A 100 ml placebo solution will be administered through an esophageal probe. 100 ml will be administered as an infusion with a rate of 7ml/min. Healthy volunteers will be treated with placebo 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.
Active Comparator: PPC-5650
PPC-5650 is a "asic-sensing ion channel"-1a antagonist that can block the acid-sensing ion channels, leading to a reduction in the pain signal under up-regulated conditions. A dose of 2.5 mg PPC-5650 in a 100 ml solution will be administered through an esophageal probe to assess local effects. 100 ml will be administered as an infusion with a rate of 7ml/min. Healthy volunteers will be treated with PPC-5650 in one out of three visit days.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asbjørn Mohr Drewes

Investigators

  • Principal Investigator: Asbjørn M Drewes, Professor, Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (Estimate)

March 26, 2013

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AROS-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroesophageal Reflux

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe