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Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans (tap-oxy)

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ClinicalTrials.gov Identifier: NCT01500317
Recruitment Status : Completed
First Posted : December 28, 2011
Results First Posted : December 17, 2012
Last Update Posted : December 17, 2012
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Michael Camilleri, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE May 20, 2011
First Posted Date  ICMJE December 28, 2011
Results First Submitted Date  ICMJE November 8, 2012
Results First Posted Date  ICMJE December 17, 2012
Last Update Posted Date December 17, 2012
Study Start Date  ICMJE May 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2012)
  • Colonic Transit, Geometric Center at 24 Hours [ Time Frame: 24 hours ]
    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.
  • Gastric Emptying Half-time (t1/2) at 24 Hours [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2011)
Geometric mean of counts [ Time Frame: 6 hours ]
in anterior and posterior gastric regions of interest will be used to estimate by power exponential analysis of the proportionate emptying over time of counts from 99mTc solids and 111In from the stomach. Gastric emptying from the power exponential analysis for the post injection period will be calculated and compared for the different treatments). The proportion of 99mTc and 111In and reaching the colon at 6 hours will also be estimated as a measure of orocecal (and a surrogate for small bowel) transit.
Change History Complete list of historical versions of study NCT01500317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2012)
  • Colonic Geometric Center at 8 and 48 Hours [ Time Frame: 8 hours, 48 hours ]
    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.
  • Colonic Filling at 6 Hours [ Time Frame: 6 hours ]
    Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.
  • Ascending Colon Emptying (AC t1/2) [ Time Frame: Over the first 24 hours after ingestion of the radioisotopically labeled charcoal particles ]
    Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 24 hour data.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2011)
Geometric center [ Time Frame: 8 hours ]
colonic counts for both solids and liquids at 4, 8 and 24 hours will be estimated using geometric mean of counts in ascending, transverse, descending and rectosigmoid colon and stool (weighted by factors of 1 to 5 respectively). The primary variable of interest in overall colonic transit is the geometric center at 8 hours.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans
Official Title  ICMJE Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Effects of 2 Mu-opiates on Gastrointestinal Transit
Intervention  ICMJE
  • Drug: Tapentadol
    Subjects received tapentadol immediate release formulation, 75 mg three times per day (tid) for 48 hours.
    Other Name: Tapentadol brand name: Nucynta
  • Drug: Oxycodone
    Subjects received oxycodone immediate release formulation, 5 mg three times per day (tid) for 48 hours.
    Other Names:
    • Dazidox
    • ETH-Oxydose
    • Endocodone
    • Oxecta
    • Oxy IR
    • Oxycontin
    • Oxyfast
    • Percolone
    • Roxicodone
  • Drug: Placebo
    Subjects received placebo three times per day (tid) for 48 hours.
Study Arms  ICMJE
  • Active Comparator: Tapentadol
    75 mg tapentadol tid
    Intervention: Drug: Tapentadol
  • Active Comparator: Oxycodone
    5 mg oxycodone tid
    Intervention: Drug: Oxycodone
  • Placebo Comparator: Placebo
    Placebo tid
    Intervention: Drug: Placebo
Publications * Not Provided

*   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: January 26, 2012)
38
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2011)
36
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Healthy volunteers Inclusion criteria

  1. Males and non-pregnant, non-breastfeeding females
  2. 18-65 years old

Exclusion criteria

  1. Use of any mu-opioid agent in the last 3 months
  2. 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.
  3. 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.
  4. Female subjects who are pregnant or breast feeding.
  5. 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.
  6. Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.
  7. Subjects who have participated in another clinical study within the past 30 days
  8. 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01500317
Other Study ID Numbers  ICMJE 11-002334
Pharmacodynamic study ( Other Identifier: Mayo Clinic )
UL1RR024150 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Camilleri, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Center for Research Resources (NCRR)
Investigators  ICMJE
Principal Investigator: Michael Camilleri, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date December 2012

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