An Open-label Evaluation of Tapentadol Extended Release (ER) in Participants With Moderate to Severe Chronic Pain After Conversion From Hydrocodone, Oxycodone Controlled Release (CR), and/or Morphine Sustained Release (SR)
WithdrawnPhase 4NCT01631513
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to evaluate tapentadol Extended Release (ER) in the treatment of moderate to severe chronic pain in participants with a diagnosis of chronic low back pain (LBP) or osteoarthritis (OA) of the hip or knee after conversion from hydrocodone, oxycodone Controlled Release (CR), and/or morphine Sustained Release (SR).
Study details
- Official title
- An Open-label, Multi-center, Single-arm, Phase IV Clinical Trial Assessing Conversion From Hydrocodone, Oxycodone CR or Morphine SR to Tapentadol ER in Subjects With Moderate to Severe Chronic Low Back or OA Pain of the Hip or Knee
- Conditions
- Pain
- Chronic Back Pain
- Chronic Low Back Pain
- Osteoarthritis Pain In The Hip or Knee
- Interventions
- Drug: Nucynta ER
- Sponsor
- Janssen Scientific Affairs, LLC
- Start date
- 2012-08
- Primary completion
- 2012-08
- Sex
- All
- Age range
- from 18 Years to 74 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 7
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Have a clinical diagnosis of knee or hip osteoarthritis (OA) with history of pain at the reference joint or clinical diagnosis of low back pain (LBP) of non malignant origin for at least 3 months before the screening visit; Be taking hydrocodone, oxycodone CR, or morphine SR for the treatment of chronic LBP, or OA of the knee or hip for at least 2 weeks before the screening visit; Have a baseline pain intensity score of ≥4 on an 11-point pain intensity numeric rating scale; Be willing and able to independently communicate pain characteristics, complete all protocol required measurements/assessments without assistance, understand and complete self-administered questionnaires and adhere to the prohibitions and restrictions specified in this protocol. Exclusion Criteria: * Had surgery in the low back area or the reference joint within 3 months before the screening visit, or will not have fully recovered from surgery by the screening visit, or is expected to require surgical intervention in the low back area or the reference joint during participation in the study; For participants with OA of the hip or knee, has a clinical history and findings at the reference joint suggesting the pain is secondary to crystal-induced, metabolic, infectious, and/or autoimmune disease(s); Has a known history of severe chronic renal insufficiency, severely impaired hepatic function, or alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal; Has a history of seizure disorder, epilepsy, or recurrent seizures; Has any of the following within 1 year before the screening visit: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm; Has a known or suspected history of alcohol abuse in the past 10 years or any history of drug abuse; Has a history of malignancy within 2 years before the screening visit, with the exception of basal cell carcinoma that has been successfully treated; Has significant respiratory depression, acute or severe bronchial asthma, or hypercapnia and paralytic ileus; Has a known history of allergies, hypersensitivity, or contraindication to tapentadol, hydrocodone, morphine, oxycodone, or acetaminophen or their excipients; In a participant taking oxycodone CR or morphine SR at screening, is also taking more than 2 doses per day of an IR opioid for breakthrough pain (exclusion does not apply if prior opioid is hydrocodone); Is taking daily acetaminophen at a…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01631513