Opioid Effects on Swallowing and Esophageal Sphincter Pressure
Can Opioid Induced Effects on Esophageal Motility and Lower Esophageal Sphincter be Counteracted by a Dopamine Receptor Antagonist?
1 other identifier
interventional
14
1 country
1
Brief Summary
The purpose of this study is to determine whether a dopamine receptor antagonist metoclopramide can counteract opioid induced effects on esophageal motility and lower esophageal sphincter. The aim of this study is also to evaluate if the opioid antagonist naloxone reduces the opioid induced pharyngeal and esophageal dysfunction.
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 Oct 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2010
CompletedFirst Posted
Study publicly available on registry
August 31, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFebruary 2, 2012
January 1, 2012
1 month
August 30, 2010
January 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lower esophageal sphincter pressure
2 hours
Secondary Outcomes (1)
Swallowing difficulties
2 hours
Study Arms (4)
Primperan
EXPERIMENTALNaloxon
ACTIVE COMPARATORNatriumklorid
PLACEBO COMPARATORUltiva
EXPERIMENTALInterventions
Injection fluid, solution 0,4 mg/kg Bolus infusion 6ug/kg at one occasion Continuous infusion 0,1 ug/kg/minute during 50 min
Powder for injection/ infusion fluid solution, 2 mg Infusion TCI 1ng/kg 10 min ( 0,05 ug/kg/min) Infusion TCI 2ng/kg 10 min ( 0.10 ug/kg/min) Infusion TCI 3ng/kg 20 min ( 0,15 ug/kg/min)
Infusion fluid, solution 9 mg/ml ( hydrogenic solution )
Injection fluid, solution 5 mg/mg Iv injection 0,2 mg/kg at one occasion
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 history of cardiac, pulmonary or neurological disease
- Ongoing medication
- Allergies to or history of reaction to naloxone, remifentanil, fentanyl analogues or metoclopramide
- Pregnancy or breast feeding
- BMI \> 30
- Previous participation in a medical clinical trial where opioid has been used or have during last 30 days participated in any other medicinal clinical trial or in a trial where follow-up in not completed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Örebro University Hospital
Örebro, 70185, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
August 30, 2010
First Posted
August 31, 2010
Study Start
October 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
February 2, 2012
Record last verified: 2012-01