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
Condition: Joint Diseases; Arthritis; Osteoarthritis
MeSH terms: Arthritis; Joint Diseases; Constipation
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): oxycodone CR; oxycodone IR; Tapentadol ER (CG5503); Tapentadol IR (CG5503); Tapentadol IR (CG5503); placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day); 10mg for 14 days; flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day); 50mg for 14 days; 75mg for 14 days; 1 capsule for 14 days; Tablets and capsules 2 x a day for 28 days
Intervention MeSH terms: Oxycodone; Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain medication; Arthritis; Joint pain; Analgesia; Analgesics; tapentadol; CG5503; Nucynta