Status:
COMPLETED
A Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus
Lead Sponsor:
Asbjørn Mohr Drewes
Conditions:
Gastroesophageal Reflux
Gastroesophageal Reflux Disease
Eligibility:
MALE
20-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01818570
Start Date
January 1 2013
End Date
January 1 2014
Last Update
May 14 2014
Active Locations (1)
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1
Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital
Aalborg, Jutland, Denmark, 9000