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Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans

NCT01500317 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2012-12-17

Study results available
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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 off label use in chronic pain.

Tapentadol is a new molecular entity that is structurally similar to tramadol. Tapentadol is a centrally-acting analgesic with a dual mode of action as an agonist at the mu-opioid receptor and as a norepinephrine reuptake inhibitor. These two actions are synergistic in pain relief. While its action reflects aspects of tramadol and morphine, its ability to control pain is more on the order of hydrocodone and oxycodone.

Its dual mode of action provides analgesia at similar levels of more potent narcotic analgesics such as hydrocodone, oxycodone, and meperidine with a more tolerable side effect profile. Clinical studies showed that tapentadol effectively relieves moderate to severe pain in various pain care settings. In addition, it was reported to be associated with significantly fewer treatment discontinuations due to a significantly lower incidence of gastrointestinal-related adverse events compared with equivalent doses of oxycodone. The combination of these reduced treatment discontinuation rates and tapentadol efficacy for the relief of moderate to severe nociceptive and neuropathic pain may offer an improvement in pain therapy by increasing patient compliance with their treatment regimen.

Conditions

  • Effects of 2 Mu-opiates on Gastrointestinal Transit

Interventions

DRUG

Tapentadol

Subjects received tapentadol immediate release formulation, 75 mg three times per day (tid) for 48 hours.

DRUG

Oxycodone

Subjects received oxycodone immediate release formulation, 5 mg three times per day (tid) for 48 hours.

DRUG

Placebo

Subjects received placebo three times per day (tid) for 48 hours.

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Michael Camilleri, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-10-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01500317 on ClinicalTrials.gov