Gastroesophageal RefluxPhase 1NCT01818570
A Study of Local Effect and Safety of a Single PPC-5650 Dose on Reflux Pain During Pain Stimulation in the Esophagus
A Phase 1 study testing PPC-5650 in people with Gastroesophageal Reflux and Gastroesophageal Reflux Disease, run by Asbjørn Mohr Drewes at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux, Gastroesophageal Reflux Disease
- What is being tested?
- PPC-5650
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jan 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital
Aalborg, Jutland, 9000
About this study
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
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.
- Being tested
- PPC-5650, Placebo
- Keywords
- Gastroesophageal Reflux
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPC-5650Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: PPC-5650 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical)
Measured: 4 hours
Secondary outcomes (1)
Number of observed adverse effects (safety profile) and changes in size of referred pain area
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asbjørn Mohr Drewes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asbjørn Mohr Drewes, Aalborg University Hospital
- Investigators
- Asbjørn M Drewes, Professor, Principal investigator, Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818570
- Sponsor's protocol ID
- AROS-002
- Status last verified
- May 2014
- First submitted
- 22 Mar 2013
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25483563
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01818570
- Acronym / sponsor ID
- AROS-002
- Keywords
- Gastroesophageal Reflux
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Asbjørn Mohr DrewesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo solution | Placebo comparator | Drug: PlaceboA 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 | Active comparator | Drug: PPC-5650PPC-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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPC-5650A 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. | Drug | PPC-5650 |
| PlaceboA 100 ml placebo solution will be administered to the esophagus with an infusion rate of 7ml/min in one out of three visit days. | Drug | Placebo solution |
Primary outcome
Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical)
Time frame: 4 hours
1 secondary outcome
Number of observed adverse effects (safety profile) and changes in size of referred pain area
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
- Derived from this study: PubMed 25483563Olesen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asbjørn M Drewes, Professor principal investigator
Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PPC-5650 in people with Gastroesophageal Reflux and Gastroesophageal Reflux Disease, run by Asbjørn Mohr Drewes at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain scores recorded after multimodal pain stimulations (mechanical, thermal, electrical, and chemical) (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01818570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.