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
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Arm, Multicenter Study in Subjects With End-Stage Joint Disease to Compare the Frequency of Constipation Symptoms in SubjectsTreated With Tapentadol IR and Oxycodone IR Using a Bowel Function Patient Diary
2 other identifiers
interventional
597
0 countries
N/A
Brief Summary
The purpose of this study is to compare bowel function/constipation that occurs during tapentadol treatment with that occuring during oxycodone treatment, as measured by the frequency of spontaneous bowel movements per week. The frequency of spontaneous bowel movements will be determined from a Bowel Function Patient Diary completed by the enrolled sujbects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2008
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 31, 2008
CompletedFirst Posted
Study publicly available on registry
November 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
February 13, 2012
CompletedFebruary 13, 2012
January 1, 2012
9 months
October 31, 2008
July 22, 2010
January 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
5-Day Sum of Pain Intensity Difference (SPID5)
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).
Day 1 to Day 5
Spontaneous Bowel Movements Per Week (SBMs/Week)
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.
Week 1 to Week 2
Study Arms (7)
001
EXPERIMENTALTapentadol IR (CG5503) 50mg for 14 days
002
EXPERIMENTALTapentadol IR (CG5503) 75mg for 14 days
003
ACTIVE COMPARATORoxycodone IR 10mg for 14 days
004
PLACEBO COMPARATORplacebo 1 capsule for 14 days
005
EXPERIMENTALTapentadol ER (CG5503) flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
006
ACTIVE COMPARATORoxycodone CR flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
007
PLACEBO COMPARATORplacebo Tablets and capsules 2 x a day for 28 days
Interventions
flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
Eligibility Criteria
You may qualify if:
- A clinical diagnosis of osteoarthritis of the hip or knee
- End-stage degenerative joint disease
- Eligibility for primary unilateral total or partial joint replacement surgery
- Pain level moderate to severe and at such a level as to require daily doses of an opioid analgesic medication
You may not qualify if:
- Has a life-long history of seizure disorder or epilepsy
- Had any of the following within the preceding 1 year: mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm
- Had a severe traumatic brain injury within 15 years of screening (consisting of one or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting for more than 24 hours)
- Joint pain not associated with gout, fibromyalgia, rheumatoid arthritis, other autoimmune disease
- History of alcohol or drug abuse
- chronic hepatitis B and C or HIV, active hepatitis B and C within 3 months
- Severely impaired renal function or moderately to severely impaired hepatic function
- History of cancer within past 2 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Etropolski M, Kelly K, Okamoto A, Rauschkolb C. Comparable efficacy and superior gastrointestinal tolerability (nausea, vomiting, constipation) of tapentadol compared with oxycodone hydrochloride. Adv Ther. 2011 May;28(5):401-17. doi: 10.1007/s12325-011-0018-0. Epub 2011 Apr 13.
PMID: 21494892DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Leader
- Organization
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 31, 2008
First Posted
November 3, 2008
Study Start
October 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
February 13, 2012
Results First Posted
February 13, 2012
Record last verified: 2012-01