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

NCT01818570 | Completed Phase 1 DMC

• 1 other identifier: AROS-002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroesophageal Reflux; Gastroesophageal Reflux Disease

Keywords

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical)

  4 hours

Secondary Outcomes (1)

• Number of observed adverse effects (safety profile) and changes in size of referred pain area

  1 month

Study Arms (2)

Placebo solution

PLACEBO COMPARATOR

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

PPC-5650

ACTIVE COMPARATOR

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

Interventions

PPC-5650 DRUG

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.

PPC-5650

Placebo DRUG

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.

Placebo solution

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asbjørn Mohr Drewes: lead

Study Sites (1)

Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital

Aalborg, Jutland, 9000, Denmark

Location

Related Publications (1)

• Olesen AE, Nielsen LM, Larsen IM, Drewes AM. Randomized clinical trial: efficacy and safety of PPC-5650 on experimental esophageal pain and hyperalgesia in healthy volunteers. Scand J Gastroenterol. 2015 Feb;50(2):138-44. doi: 10.3109/00365521.2014.966319. Epub 2014 Dec 8.

  PMID: 25483563 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Asbjørn M Drewes, Professor

  Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: March 26, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

DK (1)