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Completed

NCT Number: NCT01818570

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

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Disease Gastrointestinal Diseases

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

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

Aalborg, Jutland, 9000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 4 hours

Secondary outcomes

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

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Asbjørn Mohr Drewes

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 26, 2013
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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