Trial Outcomes & Findings for Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans (NCT NCT01500317)

NCT ID: NCT01500317

Last Updated: 2012-12-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 38 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2012-12-17

Participant Flow

Participant milestones

Measure	Tapentadol 75 mg tapentadol tid	Oxycodone 5 mg oxycodone tid	Placebo Placebo tid
Overall Study STARTED	13	12	13
Overall Study COMPLETED	10	10	13
Overall Study NOT COMPLETED	3	2	0

Reasons for withdrawal

Measure	Tapentadol 75 mg tapentadol tid	Oxycodone 5 mg oxycodone tid	Placebo Placebo tid
Overall Study Withdrawal by Subject	3	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tapentadol n=13 Participants 75 mg tapentadol tid	Oxycodone n=12 Participants 5 mg oxycodone tid	Placebo n=13 Participants Placebo tid	Total n=38 Participants Total of all reporting groups
Age Continuous	34.99 years STANDARD_DEVIATION 7.82 • n=5 Participants	33.26 years STANDARD_DEVIATION 12.94 • n=7 Participants	39.48 years STANDARD_DEVIATION 12 • n=5 Participants	35.98 years STANDARD_DEVIATION 11.11 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment United States	13 participants n=5 Participants	12 participants n=7 Participants	13 participants n=5 Participants	38 participants n=4 Participants
Body Mass Index (BMI)	26.27 kg/m^2 STANDARD_DEVIATION 4.88 • n=5 Participants	27.36 kg/m^2 STANDARD_DEVIATION 6.11 • n=7 Participants	25.16 kg/m^2 STANDARD_DEVIATION 4.88 • n=5 Participants	26.23 kg/m^2 STANDARD_DEVIATION 5.23 • n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Tapentadol n=13 Participants 75 mg tapentadol tid	Oxycodone n=12 Participants 5 mg oxycodone tid	Placebo n=13 Participants Placebo tid
Colonic Transit, Geometric Center at 24 Hours	2.06 units on a scale Standard Deviation 0.67	2.07 units on a scale Standard Deviation 0.6	2.17 units on a scale Standard Deviation 0.739

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Tapentadol n=13 Participants 75 mg tapentadol tid	Oxycodone n=12 Participants 5 mg oxycodone tid	Placebo n=13 Participants Placebo tid
Gastric Emptying Half-time (t1/2) at 24 Hours	159.2 minutes Standard Deviation 46.45	155.2 minutes Standard Deviation 38.44	124.7 minutes Standard Deviation 39.08

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tapentadol n=13 Participants 75 mg tapentadol tid	Oxycodone n=12 Participants 5 mg oxycodone tid	Placebo n=13 Participants Placebo tid
Colonic Geometric Center at 8 and 48 Hours Colonic geometric center at 48 hr	3.59 units on a scale Standard Deviation 1.16	3.51 units on a scale Standard Deviation 0.82	3.742 units on a scale Standard Deviation 0.83
Colonic Geometric Center at 8 and 48 Hours Colonic geometric center at 8 hr	0.78 units on a scale Standard Deviation 0.589	0.75 units on a scale Standard Deviation 0.54	0.79 units on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: 6 hours

Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.

Outcome measures

Measure	Tapentadol n=13 Participants 75 mg tapentadol tid	Oxycodone n=12 Participants 5 mg oxycodone tid	Placebo n=13 Participants Placebo tid
Colonic Filling at 6 Hours	35.55 percentage of radio-labeled meal Standard Deviation 32.3	38.6 percentage of radio-labeled meal Standard Deviation 19.5	65.54 percentage of radio-labeled meal Standard Deviation 26.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tapentadol n=13 Participants 75 mg tapentadol tid	Oxycodone n=12 Participants 5 mg oxycodone tid	Placebo n=13 Participants Placebo tid
Ascending Colon Emptying (AC t1/2)	21.92 hours Standard Deviation 9.89	19.3 hours Standard Deviation 6.27	17.88 hours Standard Deviation 6.21

Adverse Events

Tapentadol

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Oxycodone

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tapentadol n=13 participants at risk 75 mg tapentadol tid	Oxycodone n=12 participants at risk 5 mg oxycodone tid	Placebo n=13 participants at risk Placebo tid
Gastrointestinal disorders Nausea	38.5% 5/13 • Number of events 5 • 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.	33.3% 4/12 • Number of events 4 • 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.	0.00% 0/13 • 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.
Gastrointestinal disorders Vomiting	23.1% 3/13 • Number of events 3 • 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.	8.3% 1/12 • Number of events 1 • 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.	0.00% 0/13 • 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.
Nervous system disorders Headache	7.7% 1/13 • Number of events 1 • 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.	0.00% 0/12 • 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.	7.7% 1/13 • Number of events 1 • 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.
Nervous system disorders Dizziness	38.5% 5/13 • Number of events 5 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.
Nervous system disorders Light-headed	15.4% 2/13 • Number of events 2 • 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.	0.00% 0/12 • 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.	0.00% 0/13 • 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.

Additional Information

Dr. Michael Camilleri

Mayo Clinic

Phone: 507-284-6218

Email: camilleri.michael@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place