Opioids and Esophageal Function
Is the Opioid-induced Pharyngeal and Esophageal Dysfunction Peripherally or Central Mediated?
1 other identifier
interventional
13
1 country
2
Brief Summary
The purpose of this study is to evaluate if opioid-induced effects on the pharynx and esophagus is centrally or peripherally mediated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2009
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 10, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedDecember 9, 2011
December 1, 2011
2 months
November 10, 2009
December 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Does methylnaltrexone influence the upper and lower esophageal sphincter pressure and the swallowing function following opioid administration?
6 hours per volunteer
Secondary Outcomes (1)
Does methylnaltrexone influence the experience of swallowing function following opioid administration?
6 hours per volunteer
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo= normal saline
methylnaltexone
ACTIVE COMPARATORperipheral opioid antagonist
Interventions
0,15 mg/kg sc ( subcutaneously)once per volunteer
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Anaesthesiology, University Hospital Örebro
Örebro, 701 85, Sweden
University Hospital Örebro
Örebro, 701 85, Sweden
Related Publications (1)
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.
PMID: 23713743DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magnus Wattwil, MD
University Hospital Örebro
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 10, 2009
First Posted
November 13, 2009
Study Start
November 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
December 9, 2011
Record last verified: 2011-12