- ICH GCP
- US Clinical Trials Registry
- Clinical 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
January 9, 2012 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
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.
Study Overview
Status
Completed
Conditions
Detailed Description
Chronic pain from end-stage degenerative joint disease is often moderate to severe in intensity and results in a relatively constant level of pain requiring continuous pain relief medication.
Despite available pain relief medications, 60% to 80% of subjects suffering from chronic pain are currently inadequately treated.
Opioid pain medications are central to the effective treatment of moderate to severe pain.
However, opioid therapy is frequently complicated by side effects.
Constipation is one of the most commonly reported side effects and most debilitating.
An opioid medication that provides pain relief with a reduced incidence of constipation symptoms would improve the capability of subjects to stay on medication to achieve the long-term relief they need.
This is a randomized, double-blind, placebo- and active-controlled, parallel-arm, multicenter study with 4 treatment groups of subjects who have moderate to severe chronic pain from end-stage degenerative joint disease of the hip or knee and who are candidates for primary total or partial joint replacement.
The study consists of 3 periods: a pretreatment period (a 14-day screening for study eligibility and a 7-day washout of any previously taken opioid medication), a double-blind treatment period (a 14-day IR treatment phase followed by a 28-day ER treatment phase), and a follow-up period (1 study-site visit within 4 days after the last dose of study drug is taken and 1 telephone contact within 10 to 14 days after the last dose of study drug is taken).
On Day 1 of the IR treatment phase, patients will be randomly assigned to 1 of 4 possible treatment groups to receive 50 mg CG5503 IR, 75 mg CG5503 IR, 10 mg oxycodone IR, or placebo daily every 4 to 6 hours.
At the beginning of the ER treatment phase, patients' study drugs will be transitioned to the ER form (by conversion from the IR to approximate equivalent total daily doses of the ER form) of their randomly assigned study drug of tapentadol ER, oxycodone CR, or placebo.
The ER study drugs will be taken every 12 hours b.i.d.
Dosages will be adjustable, with the study site personnel oversight, to ensure adequate pain relief is provided.
Beginning with the washout period, patients will be given hand-held computer diaries in which to record their pain intensity, pain relief, bowel movement information, and answer questions on any nausea or vomiting that may occur.
In addition, patients will write down the times and dosages of all medications they take during the study in a medication diary.
Safety and tolerability will be assessed using physical examination, monitoring of adverse events, clinical and laboratory measures, and 12 lead ECG results.
The first study hypothesis is that both tapentadol IR dosages are more effective than placebo in relieving pain based on the SPID score recorded by the patients over the first 5 days of the study.
The second study hypothesis is that the Bowel Function Patient Diary results for both tapentadol IR dosages demonstrate improved tolerability compared to oxycodone IR 10 mg, based on the number of spontaneous bowel movements per week over the first 2 weeks of the study.
In the IR treatment phase, each patient will take CG5503 IR 50 mg, CG5503 IR 75 mg, oxycodone IR 10 mg, or placebo orally every 4 to 6 hours for 14 days.
In the ER treatment phase, dosages of the IR treatment groups will be converted to approximately equivalent dosages of the ER form of the assigned study drug: tapentadol ER, oxycodone CR, or placebo.
Dosages may range from 100 to 500 mg/day of tapentadol ER and 20 to 60 mg/day of oxycodone CR taken orally 2x daily for 28 days.
Study Type
Interventional
Enrollment (Actual)
597
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 001
Tapentadol IR (CG5503) 50mg for 14 days
|
50mg for 14 days
75mg for 14 days
|
EXPERIMENTAL: 002
Tapentadol IR (CG5503) 75mg for 14 days
|
50mg for 14 days
75mg for 14 days
|
ACTIVE_COMPARATOR: 003
oxycodone IR 10mg for 14 days
|
10mg for 14 days
|
PLACEBO_COMPARATOR: 004
placebo 1 capsule for 14 days
|
1 capsule for 14 days
Tablets and capsules 2 x a day for 28 days
|
EXPERIMENTAL: 005
Tapentadol ER (CG5503) flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
|
flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
|
ACTIVE_COMPARATOR: 006
oxycodone CR flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
|
flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
|
PLACEBO_COMPARATOR: 007
placebo Tablets and capsules 2 x a day for 28 days
|
1 capsule for 14 days
Tablets and capsules 2 x a day for 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
5-Day Sum of Pain Intensity Difference (SPID5)
Time Frame: 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).
|
Day 1 to Day 5
|
Spontaneous Bowel Movements Per Week (SBMs/Week)
Time Frame: 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.
|
Week 1 to Week 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (ACTUAL)
July 1, 2009
Study Completion (ACTUAL)
July 1, 2009
Study Registration Dates
First Submitted
October 31, 2008
First Submitted That Met QC Criteria
October 31, 2008
First Posted (ESTIMATE)
November 2, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
February 13, 2012
Last Update Submitted That Met QC Criteria
January 9, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Constipation
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Adrenergic Uptake Inhibitors
- Oxycodone
- Tapentadol
Other Study ID Numbers
- CR014326
- KF5503/41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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