Effects of 2 Mu-opiates on Gastrointestinal TransitPhase 4tap-oxyNCT01500317

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

A Phase 4 study testing Tapentadol and Oxycodone in people with Effects of 2 Mu-opiates on Gastrointestinal Transit, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Effects of 2 Mu-opiates on Gastrointestinal Transit
What is being tested?: Tapentadol and Oxycodone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: 1 siteUnited States
Study dates: May 2011to Dec 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Use of any mu-opioid agent in the last 3 months
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.
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.

Show all 11Show fewer

Female subjects who are pregnant or breast feeding.
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.
Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.
Subjects who have participated in another clinical study within the past 30 days
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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

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.

Read the detailed description

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

Conditions: Effects of 2 Mu-opiates on Gastrointestinal Transit
Being tested: Tapentadol, Oxycodone, Placebo
Keywords: tapentadol, oxycodone, mu-opiate, stomach, small intestine, colon, motility, nausea, constipation
Medical subject headings: Nausea, Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TapentadolDrug
Also called Tapentadol brand name: Nucynta
Subjects received tapentadol immediate release formulation, 75 mg three times per day (tid) for 48 hours.
OxycodoneDrug
Also called Dazidox, ETH-Oxydose, Endocodone, Oxecta
Subjects received oxycodone immediate release formulation, 5 mg three times per day (tid) for 48 hours.
PlaceboDrug
Subjects received placebo three times per day (tid) for 48 hours.

Study groups in NCT01500317
Study group	Role	What they receive
Tapentadol	Active comparator	75 mg tapentadol tid Receives: Drug: Tapentadol
Oxycodone	Active comparator	5 mg oxycodone tid Receives: Drug: Oxycodone
Placebo	Placebo comparator	Placebo tid Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Colonic Transit, Geometric Center at 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.
Measured: 24 hours
Gastric Emptying Half-time (t1/2) at 24 Hours
Measured: 24 hours

Secondary outcomes (3)

Colonic Geometric Center at 8 and 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.
Measured: 8 hours, 48 hours
Colonic Filling at 6 Hours
Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.
Measured: 6 hours
Ascending Colon Emptying (AC t1/2)
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.
Measured: Over the first 24 hours after ingestion of the radioisotopically labeled charcoal particles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Dec 2011

First posted28 Dec 2011 (estimated)
Study startMay 2011
Primary completionOct 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Effects of 2 Mu-opiates on Gastrointestinal TransitStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01500317
Sponsor's protocol ID: 11-002334
Other IDs: Pharmacodynamic study, UL1RR024150
Acronym: tap-oxy
Status last verified: Dec 2012
First submitted: 20 May 2011
Last updated: 17 Dec 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans
ClinicalTrials.gov ID: NCT01500317
Acronym / sponsor ID: tap-oxy / 11-002334
Conditions: Effects of 2 Mu-opiates on Gastrointestinal Transit
Keywords: tapentadol, oxycodone, mu-opiate, stomach, small intestine, colon, motility, nausea
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Center for Research Resources (NCRR)
Study start: May 2011
Primary completion: Oct 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 28 Dec 2011 (estimated)
Results: Posted 17 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Tapentadol	Active comparator	Drug: Tapentadol75 mg tapentadol tid
Oxycodone	Active comparator	Drug: Oxycodone5 mg oxycodone tid
Placebo	Placebo comparator	Drug: PlaceboPlacebo tid

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (11 listed)

Use of any mu-opioid agent in the last 3 months
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.
Unable to withdraw medications 48 hours prior to the study :
Female subjects who are pregnant or breast feeding.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TapentadolAlso: Tapentadol brand name: NucyntaSubjects received tapentadol immediate release formulation, 75 mg three times per day (tid) for 48 hours.	Drug	Tapentadol
OxycodoneAlso: Dazidox, ETH-Oxydose, Endocodone, OxectaSubjects received oxycodone immediate release formulation, 5 mg three times per day (tid) for 48 hours.	Drug	Oxycodone
PlaceboSubjects received placebo three times per day (tid) for 48 hours.	Drug	Placebo

Primary outcome

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

3 secondary outcomes

Colonic Geometric Center at 8 and 48 Hours
Time frame: 8 hours, 48 hours
Colonic Filling at 6 Hours
Time frame: 6 hours
Ascending Colon Emptying (AC t1/2)
Time frame: Over the first 24 hours after ingestion of the radioisotopically labeled charcoal particles

Results and safety

Results posted to the registry on 17 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tapentadol	13	10
Oxycodone	12	10
Placebo	13	13

Primary outcome: Colonic Transit, Geometric Center at 24 Hours

Time frame: 24 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Tapentadol n = 13	Oxycodone n = 12	Placebo n = 13
Value	2.06 (0.67)	2.07 (0.6)	2.17 (0.739)

Primary outcome: Gastric Emptying Half-time (t1/2) at 24 Hours

Time frame: 24 hours. Mean (Standard Deviation). Unit: minutes

Measure	Tapentadol n = 13	Oxycodone n = 12	Placebo n = 13
Value	159.2 (46.45)	155.2 (38.44)	124.7 (39.08)

3 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tapentadol	0 of 13 (0%)	10 of 13 (76.9%)	Not reported
Oxycodone	0 of 12 (0%)	4 of 12 (33.3%)	Not reported
Placebo	0 of 13 (0%)	1 of 13 (7.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Camilleri, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tapentadol and Oxycodone in people with Effects of 2 Mu-opiates on Gastrointestinal Transit, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Colonic Transit, Geometric Center at 24 Hours (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01500317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012; AzTrials last refreshed its copy on 7 Nov 2026.