Trial · NCT00784277

A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease

NCT00784277, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2012-02-13

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease. Trials, record NCT00784277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00784277

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease
NCT number: NCT00784277
Status: Completed
Phases: Phase 3
Enrollment: 597 participants, actual
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions: Joint Diseases, Arthritis, Osteoarthritis
Interventions: oxycodone CR, oxycodone IR, Tapentadol ER (CG5503), Tapentadol IR (CG5503), Tapentadol IR (CG5503), placebo, placebo
First posted: 2008-11-03
Last updated: 2012-02-13
Results first posted: 2012-02-13

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	5-Day Sum of Pain Intensity Difference (SPID5)	Day 1 to Day 5	SPID5 was calculated as the weighted (weights is taken as the number of hours elapsed since the previous measurement) sum of the PID collected up to 5 days. Pain intensity (PI) score is calculated as the average PI over the past 12 hours using an 11-point (0 to 10) numerical rating scale (NRS) where "0" is no pain and "10" is pain as bad as you can imagine. The difference between baseline PI at the qualifying period and current PI is pain intensity difference (PID).
Primary	Spontaneous Bowel Movements Per Week (SBMs/Week)	Week 1 to Week 2	The number of SBM over the 14-day IR treatment phase was determined from the Bowel Function Patient Diary and factored to enable a per week value to be used. An SBM is defined as any BM that has occurred without the use of a laxative, enema, suppository, or manual manipulation within the previous 24 hours.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	5-Day Sum of Pain Intensity Difference (SPID5)	Day 1 to Day 5	Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).	Units on a scale	MEAN
PRIMARY	Spontaneous Bowel Movements Per Week (SBMs/Week)	Week 1 to Week 2	Intention To Treat (ITT) population : One participant who has been treated is not included in the ITT population as no baseline pain assessment was available (Arm: Tapentadol 50 mg).	number of stools/week	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
5-Day Sum of Pain Intensity Difference (SPID5)	Placebo	98.6	Standard Deviation 134.73	Units on a scale
5-Day Sum of Pain Intensity Difference (SPID5)	Tapentadol 50 mg	153.1	Standard Deviation 184.07	Units on a scale
5-Day Sum of Pain Intensity Difference (SPID5)	Tapentadol 75 mg	161.8	Standard Deviation 187.31	Units on a scale
5-Day Sum of Pain Intensity Difference (SPID5)	Oxycodone	218.4	Standard Deviation 208.64	Units on a scale
Spontaneous Bowel Movements Per Week (SBMs/Week)	Placebo	9.9	Standard Deviation 5.16	number of stools/week
Spontaneous Bowel Movements Per Week (SBMs/Week)	Tapentadol 50 mg	9.0	Standard Deviation 4.04	number of stools/week
Spontaneous Bowel Movements Per Week (SBMs/Week)	Tapentadol 75 mg	8.6	Standard Deviation 4.65	number of stools/week
Spontaneous Bowel Movements Per Week (SBMs/Week)	Oxycodone	6.7	Standard Deviation 5.44	number of stools/week

Source ClinicalTrials.gov

Participant flow42

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
IR Treatment	STARTED	Placebo	148
IR Treatment	STARTED	Tapentadol 50 mg	151
IR Treatment	STARTED	Tapentadol 75 mg	154
IR Treatment	STARTED	Oxycodone	143
IR Treatment	STARTED	Placebo ER	0
IR Treatment	STARTED	Tapentadol ER	0
IR Treatment	STARTED	Oxycodone CR	0
IR Treatment	COMPLETED	Placebo	132
IR Treatment	COMPLETED	Tapentadol 50 mg	134
IR Treatment	COMPLETED	Tapentadol 75 mg	126

1 to 10 of 42Source ClinicalTrials.gov

See all 42 participant flow

Adverse events98

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Placebo	11	148
other	Nausea	Gastrointestinal disorders	Tapentadol 50 mg	26	151
other	Nausea	Gastrointestinal disorders	Tapentadol 75 mg	31	154
other	Nausea	Gastrointestinal disorders	Oxycodone	57	143
other	Nausea	Gastrointestinal disorders	Placebo ER	5	122
other	Nausea	Gastrointestinal disorders	Tapentadol ER	23	250
other	Nausea	Gastrointestinal disorders	Oxycodone CR	12	91
other	Constipation	Gastrointestinal disorders	Placebo	22	148
other	Constipation	Gastrointestinal disorders	Tapentadol 50 mg	21	151
other	Constipation	Gastrointestinal disorders	Tapentadol 75 mg	28	154

1 to 10 of 98Source ClinicalTrials.gov

See all 98 adverse events

Adverse event totals21

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Tapentadol 50 mg
Total, all-cause mortality	Tapentadol 75 mg
Total, all-cause mortality	Oxycodone
Total, all-cause mortality	Placebo ER
Total, all-cause mortality	Tapentadol ER
Total, all-cause mortality	Oxycodone CR
Total, other adverse events	Placebo	48	148
Total, other adverse events	Tapentadol 50 mg	65	151
Total, other adverse events	Tapentadol 75 mg	88	154

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21494892	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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