Opioids and Esophageal Function

NCT01012960

Last updated date
Study Location
Department of Anaesthesiology, University Hospital Örebro
Örebro, , 701 85, Sweden
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pharyngeal Dysfunction, Esophageal Dysfunction
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-40 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Pharyngeal Dysfunction, Esophageal DysfunctionOpioids and Esophageal Function
NCT01012960
  1. Örebro,
  2. Örebro,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Opioids and Esophageal Function
Official Title  ICMJE Is the Opioid-induced Pharyngeal and Esophageal Dysfunction Peripherally or Central Mediated?
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pharyngeal Dysfunction
  • Esophageal Dysfunction
Intervention  ICMJE Drug: methylnaltrexone
0,15 mg/kg sc ( subcutaneously)once per volunteer
Other Name: Relistor
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo= normal saline
    Intervention: Drug: methylnaltrexone
  • Active Comparator: methylnaltexone
    peripheral opioid antagonist
    Intervention: Drug: methylnaltrexone
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2010)
13
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2009)
12
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01012960
Other Study ID Numbers  ICMJE JS001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johanna Savilampi, Region Örebro County
Study Sponsor  ICMJE Region Örebro County
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Magnus Wattwil, MDUniversity Hospital Örebro
PRS Account Region Örebro County
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP