Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00784277
First received: October 31, 2008
Last updated: January 9, 2012
Last verified: January 2012

October 31, 2008
January 9, 2012
October 2008
July 2009   (final data collection date for primary outcome measure)
  • 5-Day Sum of Pain Intensity Difference (SPID5) [ Time Frame: Day 1 to Day 5 ] [ Designated as safety issue: No ]
    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).
  • Spontaneous Bowel Movements Per Week (SBMs/Week) [ Time Frame: Week 1 to Week 2 ] [ Designated as safety issue: Yes ]
    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.
The primary endpoints are the 5-day Sum of Pain Intensity Difference (SPID) and the Number of Spontaneous Bowel Movements per Week.
Complete list of historical versions of study NCT00784277 on ClinicalTrials.gov Archive Site
Not Provided
The secondary endpoints are derived pain severity and relief measures and the severity of constipation associated bowel symptoms.
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Joint Diseases
  • Arthritis
  • Osteoarthritis
  • Drug: oxycodone CR
    flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
  • Drug: oxycodone IR
    10mg for 14 days
  • Drug: Tapentadol ER (CG5503)
    flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
  • Drug: Tapentadol IR (CG5503)
    50mg for 14 days
  • Drug: Tapentadol IR (CG5503)
    75mg for 14 days
  • Drug: placebo
    1 capsule for 14 days
  • Drug: placebo
    Tablets and capsules 2 x a day for 28 days
  • Experimental: 001
    Tapentadol IR (CG5503) 50mg for 14 days
    Intervention: Drug: Tapentadol IR (CG5503)
  • Experimental: 002
    Tapentadol IR (CG5503) 75mg for 14 days
    Intervention: Drug: Tapentadol IR (CG5503)
  • Active Comparator: 003
    oxycodone IR 10mg for 14 days
    Intervention: Drug: oxycodone IR
  • Placebo Comparator: 004
    placebo 1 capsule for 14 days
    Intervention: Drug: placebo
  • Experimental: 005
    Tapentadol ER (CG5503) flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day)
    Intervention: Drug: Tapentadol ER (CG5503)
  • Active Comparator: 006
    oxycodone CR flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day)
    Intervention: Drug: oxycodone CR
  • Placebo Comparator: 007
    placebo Tablets and capsules 2 x a day for 28 days
    Intervention: Drug: placebo
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. Epub 2011 Apr 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
597
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00784277
CR014326, KF5503/41
No
Senior Director, Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Grünenthal GmbH
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP