Status:
COMPLETED
Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Effects of 2 Mu-opiates on Gastrointestinal Transit
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Tapentadol is FDA approved for the treatment of moderate to severe acute pain. Due to the dual mechanism of action as an opioid agonist and norepinephrine reuptake inhibitor, there is potential for of...
Detailed Description
Single center, parallel group, randomized controlled trial of tapentadol, oxycodone and placebo effects on gastrointestinal and colonic transit in healthy human volunteers
Eligibility Criteria
Inclusion
- Healthy volunteers Inclusion criteria
- Males and non-pregnant, non-breastfeeding females
- 18-65 years old
- Exclusion criteria
- Use of any mu-opioid agent in the last 3 months
- Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. For screening the shortened screening version of the Bowel Disease Questionnaire (Appendix) will be used to exclude subjects with dyspepsia, irritable bowel syndrome or significant gastrointestinal symptoms. Of 19 questions, participants have to have three or less positives to be eligible to participate.
- Unable to withdraw medications 48 hours prior to the study :
- Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, selective serotonin re-uptake inhibitors (SSRIs) and newer antidepressants.
- Analgesic drugs including opiates, nonsteroidal anti-inflammatory drugs (NSAIDs), COX 2 inhibitors
- SSRI NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
- Female subjects who are pregnant or breast feeding.
- Clinical evidence (including physical exam, ECG, hemoglobin level and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
- Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.
- Subjects who have participated in another clinical study within the past 30 days
- History of porphyria, renal (creatinine \> 1.5mg/dL) or significant liver impairment (transaminases, alkaline phosphatase of gamma-glutamyl transpeptidase (GGT) \>2 times upper limit of normal)
Exclusion
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01500317
Start Date
May 1 2011
End Date
December 1 2011
Last Update
December 17 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905