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.
Asbjørn Mohr Drewes
Information provided by (Responsible Party):
Asbjørn Mohr Drewes, Aalborg Universityhospital
First received: March 22, 2013
Last updated: February 19, 2014
Last verified: February 2014
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.
Gastroesophageal Reflux Disease
|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 ]
|Study Start Date:||January 2013|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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.
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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01818570
|Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital|
|Aalborg, Jutland, Denmark, 9000|
Sponsors and Collaborators
Asbjørn Mohr Drewes
|Principal Investigator:||Asbjørn M Drewes, Professor||Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital|