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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Asbjørn Mohr Drewes, Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT01818570
First received: March 22, 2013
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux
Gastroesophageal Reflux Disease
Drug: PPC-5650
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of observed adverse effects (safety profile) and changes in size of referred pain area [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01818570

Locations
Denmark
Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital
Aalborg, Jutland, Denmark, 9000
Sponsors and Collaborators
Asbjørn Mohr Drewes
Investigators
Principal Investigator: Asbjørn M Drewes, Professor Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital
  More Information

No publications provided

Responsible Party: Asbjørn Mohr Drewes, Professor, MD, PhD, Aalborg Universityhospital
ClinicalTrials.gov Identifier: NCT01818570     History of Changes
Other Study ID Numbers: AROS-002
Study First Received: March 22, 2013
Last Updated: February 19, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Health and Medicines Authority

Keywords provided by Aalborg Universityhospital:
Gastroesophageal Reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 15, 2014