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

A

Asbjørn Mohr Drewes

Status and phase

Completed
Phase 1

Conditions

Gastroesophageal Reflux Disease
Gastroesophageal Reflux

Treatments

Drug: PPC-5650
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01818570
AROS-002

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

Male

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

25 participants in 2 patient groups, including a placebo group

Placebo solution
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo
PPC-5650
Active Comparator group
Description:
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.
Treatment:
Drug: PPC-5650

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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