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)
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).
Chronic Back Pain
Chronic Low Back Pain
Osteoarthritis Pain In The Hip or Knee
Drug: Nucynta ER
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change in pain intensity from baseline to end of study as measured on an 11-point numeric rating scale (NRS) [ Time Frame: Day 1 and Day 29 ] [ Designated as safety issue: No ]The pain intensity NRS is a commonly used pain scale that is a core recommended outcome measure for chronic pain studies. A score of 0 indicates "no pain" and a score of 10 indicates "pain as bad as you can imagine." Change in pain intensity is measured from baseline to the end of treatment.
- 11-point pain intensity numeric rating scale (NRS) (twice daily) and diary compliance [ Time Frame: Day 1, Day 8, Day 15, Day 22, Day 29 ] [ Designated as safety issue: No ]The pain intensity NRS is a commonly used pain scale that is a core recommended outcome measure for chronic pain studies. A score of 0 indicates "no pain" and a score of 10 indicates "pain as bad as you can imagine."
- Quality of life as measured by the SF-12v2® Health Survey [ Time Frame: Day 8, Day 15, Day 22, Day 29 ] [ Designated as safety issue: No ]The SF-12v2® is a 12-item health survey instrument that is used to evaluate the subject's physical, social, and mental well-being. Results are expressed in terms of 2 composite scores: the Physical Component Scale (PCS) and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100. Lowest scores mean very much below and highest scores mean very much above the general population average.
- Pain interference as measured by the Brief Pain Intensity-Short Form (BPI-SF) questionnaire [ Time Frame: Day 8, Day 15, Day 22, Day 29 ] [ Designated as safety issue: No ]The BPI-SF is a self-administered, validated tool for the assessment of severity of pain and the impact of pain on daily functions, location of pain, pain medications, and amount of pain relief in the last week. The BPI-SF uses a numeric rating scale (NRS) from 0 to 10, lower score denotes less severity and impact, higher score denotes more severity and impact.
- Sleep quality as measured by the Sleep Questionnaire [ Time Frame: Day 1, Day 8, Day 15, Day 22, Day 29 ] [ Designated as safety issue: No ]The 4-item Sleep Questionnaire is a validated instrument including the 4 main concepts that are considered standard and are consistently measured via sleep diaries: latency, time slept, number of awakenings, and quality experienced by the subject during the preceding night.
- Extent of neuropathic pain as measured by the painDETECT questionnaire (PDQ) [ Time Frame: Day 8, Day 29 ] [ Designated as safety issue: No ]The PDQ is a simple evaluation tool to help identify the presence of neuropathic pain. It consists of 12 questions that ask about the intensity and quality of the patient's pain. A score between 0 and 12 is "negative" (no neuropathic pain component). A score between 19 and 38 is "positive" (presence of neuropathic component)". Scores from 13 to 18 are "unclear".
- Participant rating of overall treatment status as measured by the patient global impression of change (PGIC) [ Time Frame: Day 29 ] [ Designated as safety issue: No ]The PGIC is a questionnaire that assesses the subject's global improvement since starting study treatment. It uses a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Nucynta ER
Nucynta ER will be 100 to 250 mg every 12 hours
Drug: Nucynta ER
100 to 250 mg every 12 hours
Other Name: Nucynta Extended Release
This is a multi-center, single group, open-label (all people know the identity of the intervention) treatment study to describe the overall clinical experience in participants with moderate to severe chronic low back pain or OA pain of the hip or knee, after conversion from hydrocodone, oxycodone CR, and/or morphine SR, using dose-conversion ratios of 1:5, 1:5 and 1:2.5, respectively.
Approximately 150 participants taking hydrocodone, oxycodone CR, and/or morphine SR with baseline pain intensity ≥4 (ie, pain intensity scores averaged over the last 4 days of the screening period on an 11-point numeric rating scale [NRS]) will be converted to an initial dose of tapentadol ER 100, 150 or 200 mg approximately every 12 hours based on their total daily dose of prior opioids. Enrollment of participants in any prior opioid group (hydrocodone, oxycodone CR, and/or morphine SR) may be stopped at any time during the study to ensure adequate representation of each prior opioid.
The study will consist of two periods: screening (1 Week) and treatment (4 weeks). The expected duration of participation for individual participants is approximately 5 weeks, including 4 weeks of active study treatment. The study will include scheduled visits and may also include unscheduled phone calls and site visits for dose adjustment and/or for safety evaluations.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631513
|United States, Florida|
|Jacksonville, Florida, United States|
|United States, Kansas|
|Prairie Village, Kansas, United States|
|United States, Louisiana|
|Mandeville, Louisiana, United States|
|Metairie, Louisiana, United States|
|New Orleans, Louisiana, United States|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States|
|United States, Utah|
|Clinton, Utah, United States|
|Study Director:||Janssen Scientific Affairs, LLC Clinical Trial||Janssen Scientific Affairs, LLC|