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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818570
• Other study ID #: AROS-002
• Status: Completed
• Phase: Phase 1
• First received: March 22, 2013
• Last updated: May 13, 2014
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: Aalborg Universitetshospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital	Aalborg	Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Asbjørn Mohr Drewes

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical)		4 hours	No
Secondary	Number of observed adverse effects (safety profile) and changes in size of referred pain area		1 month	Yes