Conditions: Effects of 2 Mu-opiates on Gastrointestinal Transit
Keywords: tapentadol oxycodone mu-opiate stomach small intestine colon motility nausea constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 38
Healthy volunteers: yes

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 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.

Detailed description:
Single center, parallel group, randomized controlled trial of tapentadol, oxycodone and placebo effects on gastrointestinal and colonic transit in healthy human volunteers

Arms:
arm 1: 75 mg tapentadol tid arm 2: 5 mg oxycodone tid arm 3: Placebo tid

Interventions: intervention 1: Tapentadol intervention 2: Oxycodone intervention 3: Placebo
Intervention descriptions: intervention 1: Subjects received tapentadol immediate release formulation, 75 mg three times per day (tid) for 48 hours. intervention 2: Subjects received oxycodone immediate release formulation, 5 mg three times per day (tid) for 48 hours. intervention 3: Subjects received placebo three times per day (tid) for 48 hours.

Protocol document: