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: May 13, 2014
Last verified: May 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 Universitetshospital:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 13, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Health and Medicines Authority

Keywords provided by Aalborg Universitetshospital:
Gastroesophageal Reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014