Back to resultsA Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus
Primary Purpose
Gastroesophageal Reflux, Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
PPC-5650
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Gastroesophageal Reflux
Eligibility Criteria
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
Sites / Locations
- Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo solution
PPC-5650
Arm 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.
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.
Outcomes
Primary Outcome Measures
Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical)
Secondary Outcome Measures
Number of observed adverse effects (safety profile) and changes in size of referred pain area
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01818570
Brief Title
A Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asbjørn Mohr Drewes
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Gastroesophageal Reflux Disease
Keywords
Gastroesophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo solution
Arm Type
Placebo Comparator
Arm 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.
Arm Title
PPC-5650
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
PPC-5650
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical)
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Number of observed adverse effects (safety profile) and changes in size of referred pain area
Time Frame
1 month
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asbjørn M Drewes, Professor
Organizational Affiliation
Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital
City
Aalborg
State/Province
Jutland
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25483563
Citation
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.
Results Reference
derived
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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
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