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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Condition Effects of 2 Mu-opiates on Gastrointestinal Transit
Interventions Drug: Tapentadol
Drug: Oxycodone
Drug: Placebo
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tapentadol Oxycodone Placebo
Hide Arm/Group Description 75 mg tapentadol tid 5 mg oxycodone tid Placebo tid
Period Title: Overall Study
Started 13 12 13
Completed 10 10 13
Not Completed 3 2 0
Reason Not Completed
Withdrawal by Subject             3             2             0
Arm/Group Title Tapentadol Oxycodone Placebo Total
Hide Arm/Group Description 75 mg tapentadol tid 5 mg oxycodone tid Placebo tid Total of all reporting groups
Overall Number of Baseline Participants 13 12 13 38
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 13 participants 38 participants
34.99  (7.82) 33.26  (12.94) 39.48  (12) 35.98  (11.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 13 participants 38 participants
Female
9
  69.2%
9
  75.0%
10
  76.9%
28
  73.7%
Male
4
  30.8%
3
  25.0%
3
  23.1%
10
  26.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 12 participants 13 participants 38 participants
13 12 13 38
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 13 participants 12 participants 13 participants 38 participants
26.27  (4.88) 27.36  (6.11) 25.16  (4.88) 26.23  (5.23)
1.Primary Outcome
Title Colonic Transit, Geometric Center at 24 Hours
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapentadol Oxycodone Placebo
Hide Arm/Group Description:
75 mg tapentadol tid
5 mg oxycodone tid
Placebo tid
Overall Number of Participants Analyzed 13 12 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.06  (0.67) 2.07  (0.6) 2.17  (0.739)
2.Primary Outcome
Title Gastric Emptying Half-time (t1/2) at 24 Hours
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapentadol Oxycodone Placebo
Hide Arm/Group Description:
75 mg tapentadol tid
5 mg oxycodone tid
Placebo tid
Overall Number of Participants Analyzed 13 12 13
Mean (Standard Deviation)
Unit of Measure: minutes
159.2  (46.45) 155.2  (38.44) 124.7  (39.08)
3.Secondary Outcome
Title Colonic Geometric Center at 8 and 48 Hours
Hide Description 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.
Time Frame 8 hours, 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapentadol Oxycodone Placebo
Hide Arm/Group Description:
75 mg tapentadol tid
5 mg oxycodone tid
Placebo tid
Overall Number of Participants Analyzed 13 12 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Colonic geometric center at 8 hr 0.78  (0.589) 0.75  (0.54) 0.79  (0.98)
Colonic geometric center at 48 hr 3.59  (1.16) 3.51  (0.82) 3.742  (0.83)
4.Secondary Outcome
Title Colonic Filling at 6 Hours
Hide Description Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapentadol Oxycodone Placebo
Hide Arm/Group Description:
75 mg tapentadol tid
5 mg oxycodone tid
Placebo tid
Overall Number of Participants Analyzed 13 12 13
Mean (Standard Deviation)
Unit of Measure: percentage of radio-labeled meal
35.55  (32.3) 38.6  (19.5) 65.54  (26.1)
5.Secondary Outcome
Title Ascending Colon Emptying (AC t1/2)
Hide Description 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.
Time Frame Over the first 24 hours after ingestion of the radioisotopically labeled charcoal particles
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapentadol Oxycodone Placebo
Hide Arm/Group Description:
75 mg tapentadol tid
5 mg oxycodone tid
Placebo tid
Overall Number of Participants Analyzed 13 12 13
Mean (Standard Deviation)
Unit of Measure: hours
21.92  (9.89) 19.3  (6.27) 17.88  (6.21)
Time Frame Adverse events were recorded during visits, and participants were contacted 5-7 days following the last dose of study medication to determine if any adverse events had occurred.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tapentadol Oxycodone Placebo
Hide Arm/Group Description 75 mg tapentadol tid 5 mg oxycodone tid Placebo tid
All-Cause Mortality
Tapentadol Oxycodone Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tapentadol Oxycodone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/12 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tapentadol Oxycodone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/13 (76.92%)      4/12 (33.33%)      1/13 (7.69%)    
Gastrointestinal disorders       
Nausea   5/13 (38.46%)  5 4/12 (33.33%)  4 0/13 (0.00%)  0
Vomiting   3/13 (23.08%)  3 1/12 (8.33%)  1 0/13 (0.00%)  0
Nervous system disorders       
Headache   1/13 (7.69%)  1 0/12 (0.00%)  0 1/13 (7.69%)  1
Dizziness   5/13 (38.46%)  5 0/12 (0.00%)  0 0/13 (0.00%)  0
Light-headed   2/13 (15.38%)  2 0/12 (0.00%)  0 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Michael Camilleri
Organization: Mayo Clinic
Phone: 507-284-6218
Responsible Party: Michael Camilleri, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01500317     History of Changes
Other Study ID Numbers: 11-002334
Pharmacodynamic study ( Other Identifier: Mayo Clinic )
UL1RR024150 ( U.S. NIH Grant/Contract )
First Submitted: May 20, 2011
First Posted: December 28, 2011
Results First Submitted: November 8, 2012
Results First Posted: December 17, 2012
Last Update Posted: December 17, 2012