Trial record 1 of 146 for: Open Studies | "Gastroesophageal Reflux"
A Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus
This study is currently recruiting participants.
Verified March 2013 by Aalborg Universityhospital
Asbjørn Mohr Drewes
Information provided by (Responsible Party):
Asbjørn Mohr Drewes, Aalborg Universityhospital
First received: March 22, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
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|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (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
|Contact: Lecia M Nielsen, PhD-student||+45 99 32 62 email@example.com|
|Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital||Recruiting|
|Aalborg, Jutland, Denmark, 9000|
Sponsors and Collaborators
Asbjørn Mohr Drewes
|Principal Investigator:||Asbjørn M Drewes, Professor||Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital|