Pharyngeal DysfunctionPhase 4NCT01012960
Opioids and Esophageal Function
A Phase 4 study testing methylnaltrexone in people with Pharyngeal Dysfunction and Esophageal Dysfunction, run by Region Örebro County at 2 sites in Sweden.
Trial summary
The purpose of this study is to evaluate if opioid-induced effects on the pharynx and esophagus is centrally or peripherally mediated. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharyngeal Dysfunction, Esophageal Dysfunction
- What is being tested?
- methylnaltrexone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesSweden
- Study dates
- Nov 2009to Jan 2010
- Phase
- Phase 4
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 -40 year old healthy volunteers from both sexes.
- have signed and dated Informed Consent.
- willing and able to comply with the protocol for the duration of the trial.
Who cannot join
- anamnesis of pharyngoesophageal dysfunction.
- known or history of cardiac, pulmonary or neurological disease.
- ongoing medication.
- allergies to or history of reaction to methylnaltrexone, remifentanil or fentanyl analogues.
- pregnancy or breast feeding.
- participation in another clinical medicinal trial during the last 30 days or where follow-up is not completed.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Department of Anaesthesiology, University Hospital Örebro
Örebro, 701 85
University Hospital Örebro
Örebro, 701 85
About this study
Official title: Is the Opioid-induced Pharyngeal and Esophageal Dysfunction Peripherally or Central Mediated?
The purpose of this study is to evaluate if opioid-induced effects on the pharynx and esophagus is centrally or peripherally mediated.
Read the detailed description
Opioids induce pharyngeal and esophageal dysfunction and reduce the lower esophageal sphincter (LES) pressure, and thereby decreases the barrier pressure between the stomach and esophagus. This contributes to an increased risk of regurgitation and aspiration during anaesthesia induction and in the postoperative period, when the patient is treated with opioids for pain relief. The effects of opioid antagonists on the opioid induced pharyngeal dysfunction and lower esophageal sphincter pressure are unknown. Therefore it is of great clinical value to evaluate if these negative effects are reversed by peripheral opioid antagonist, methylnaltrexone.
Methylnaltrexone is one of the newer agents of peripherally acting opioid antagonists that act to reverse some of the side effects of opioid drugs, such as constipation, without affecting analgesia.
If the opioid induced pharyngeal and esophageal dysfunction and reduction of the lower esophageal sphincter pressure is peripherally induced or mediated via peripheral opioid receptors, methylnaltrexone might reverse these effects and thereby reduce postoperative morbidity by reducing pulmonary complications. On the other hand, if the dysfunction is centrally induced and not mediated via peripheral opioid receptors there is no effect of methylnaltrexone.
The pharyngeal and esophageal motility/function can be registered in an easy and objective way with the high resolution manometry, ManoScan 360. ManoScan 360 is an equipment with 36 sensors at 1 cm spacing with 12 tip transducers at every sensor. The 36 closely spaced sensors automatically capture all relevant motor function from the pharynx to the stomach. The system collects reliable and consistent data records with improved diagnostic accuracy, and the data are analyzed using ManoView analyzes software. ManoScan 360 has a CE mark approval and has been used at Örebro University Hospital during the last two years.
- Conditions
- Pharyngeal Dysfunction, Esophageal Dysfunction
- Being tested
- methylnaltrexone
- Keywords
- methylnaltrexone, upper esophageal sphincter, lower esophageal sphincter, high resolution solid state manometry, opioid induced pharyngeal and esophageal dysfunction
- Medical subject headings
- Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylnaltrexoneDrug
Also called Relistor
0,15 mg/kg sc ( subcutaneously)once per volunteer
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo= normal saline Receives: Drug: methylnaltrexone |
| methylnaltexone | Active comparator | peripheral opioid antagonist Receives: Drug: methylnaltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does methylnaltrexone influence the upper and lower esophageal sphincter pressure and the swallowing function following opioid administration?
Measured: 6 hours per volunteer
Secondary outcomes (1)
Does methylnaltrexone influence the experience of swallowing function following opioid administration?
Measured: 6 hours per volunteer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2010
- Study completionJan 2010
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 Pharyngeal DysfunctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Principal investigator, Johanna Savilampi, Region Örebro County
- Investigators
- Magnus Wattwil, MD, Principal investigator, University Hospital Örebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012960
- Sponsor's protocol ID
- JS001
- Status last verified
- Dec 2011
- First submitted
- 10 Nov 2009
- Last updated
- 9 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Savilampi J, Ahlstrand R, Magnuson A, Wattwil M. Effects of remifentanil on the esophagogastric junction and swallowing. Acta Anaesthesiol Scand. 2013 Sep;57(8):1002-9. doi: 10.1111/aas.12134. Epub 2013 May 29.
PubMed 23713743
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Opioid-induced Pharyngeal and Esophageal Dysfunction Peripherally or Central Mediated?
- ClinicalTrials.gov ID
- NCT01012960
- Acronym / sponsor ID
- JS001
- Conditions
- Pharyngeal Dysfunction, Esophageal Dysfunction
- Keywords
- methylnaltrexone, upper esophageal sphincter, lower esophageal sphincter, high resolution solid state manometry, opioid induced pharyngeal and esophageal dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Nov 2009 (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 study is to evaluate if opioid-induced effects on the pharynx and esophagus is centrally or peripherally mediated.
Detailed description
Opioids induce pharyngeal and esophageal dysfunction and reduce the lower esophageal sphincter (LES) pressure, and thereby decreases the barrier pressure between the stomach and esophagus. This contributes to an increased risk of regurgitation and aspiration during anaesthesia induction and in the postoperative period, when the patient is treated with opioids for pain relief. The effects of opioid antagonists on the opioid induced pharyngeal dysfunction and lower esophageal sphincter pressure are unknown. Therefore it is of great clinical value to evaluate if these negative effects are reversed by peripheral opioid antagonist, methylnaltrexone.
Methylnaltrexone is one of the newer agents of peripherally acting opioid antagonists that act to reverse some of the side effects of opioid drugs, such as constipation, without affecting analgesia.
If the opioid induced pharyngeal and esophageal dysfunction and reduction of the lower esophageal sphincter pressure is peripherally induced or mediated via peripheral opioid receptors, methylnaltrexone might reverse these effects and thereby reduce postoperative morbidity by reducing pulmonary complications. On the other hand, if the dysfunction is centrally induced and not mediated via peripheral opioid receptors there is no effect of methylnaltrexone.
The pharyngeal and esophageal motility/function can be registered in an easy and objective way with the high resolution manometry, ManoScan 360. ManoScan 360 is an equipment with 36 sensors at 1 cm spacing with 12 tip transducers at every sensor. The 36 closely spaced sensors automatically capture all relevant motor function from the pharynx to the stomach. The system collects reliable and consistent data records with improved diagnostic accuracy, and the data are analyzed using ManoView analyzes software. ManoScan 360 has a CE mark approval and has been used at Örebro University Hospital during the last two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: methylnaltrexonePlacebo= normal saline |
| methylnaltexone | Active comparator | Drug: methylnaltrexoneperipheral opioid antagonist |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 -40 year old healthy volunteers from both sexes.
- have signed and dated Informed Consent.
- willing and able to comply with the protocol for the duration of the trial.
Key exclusion criteria (6 listed)
- anamnesis of pharyngoesophageal dysfunction.
- known or history of cardiac, pulmonary or neurological disease.
- ongoing medication.
- allergies to or history of reaction to methylnaltrexone, remifentanil or fentanyl analogues.
- pregnancy or breast feeding.
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 |
|---|---|---|
| methylnaltrexoneAlso: Relistor0,15 mg/kg sc ( subcutaneously)once per volunteer | Drug | Placebo, methylnaltexone |
Primary outcome
Does methylnaltrexone influence the upper and lower esophageal sphincter pressure and the swallowing function following opioid administration?
Time frame: 6 hours per volunteer
1 secondary outcome
Does methylnaltrexone influence the experience of swallowing function following opioid administration?
Time frame: 6 hours per volunteer
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 9 Dec 2011.
- Derived from this study: PubMed 23713743Savilampi J, Ahlstrand R, Magnuson A, Wattwil M. Effects of remifentanil on the esophagogastric junction and swallowing. Acta Anaesthesiol Scand. 2013 Sep;57(8):1002-9. doi: 10.1111/aas.12134. Epub 2013 May 29.
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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.
Magnus Wattwil, MD principal investigator
University Hospital Örebro
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylnaltrexone in people with Pharyngeal Dysfunction and Esophageal Dysfunction, run by Region Örebro County at 2 sites in Sweden.
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 3 inclusion and 6 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 9 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Does methylnaltrexone influence the upper and lower esophageal sphincter pressure and the swallowing function following opioid administration? (time frame: 6 hours per volunteer). 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 NCT01012960, 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 9 Dec 2011.