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NCT01500317 · ClinicalTrials.gov registry record · Phase 4
Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
NCT01500317: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT01500317 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 38 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01500317, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
Study 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.
Primary Outcome
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Interventions
- DRUG Placebo
- DRUG Oxycodone
- DRUG Tapentadol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2011-05 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
What the finished NCT01500317 record still lists
NCT01500317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01500317 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01500317 about?
NCT01500317 is a clinical study titled "Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans". 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 t...
What is the current status of trial NCT01500317?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2011-05. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01500317?
The interventions under investigation include: Placebo (DRUG), Oxycodone (DRUG), Tapentadol (DRUG).
Who is sponsoring clinical trial NCT01500317?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01500317's enrollment target sits among peer trials
38 1476th of 2000 higher than 519 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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