Phase 2
Completed N=91
An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants
Postoperative Pain · Low Back Pain · Back Pain · Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT01124604 ↗
Enrolled (actual)
91
Serious AEs
3.3%
Results posted
Apr 2013
Primary outcomePrimary: Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12 — 6.9; 6.9; -3.0; -2.9 Units on a scale
Summary
The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12 |
6.9; 6.9; -3.0; -2.9 | — |
| SECONDARY Change From Baseline in 11-point Numerical Rating Scale (NRS) |
-0.6; -0.7; -1.1; -1.3; -1.5; -1.6 | — |
| SECONDARY Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS) |
55.0; 61.3; 40.0; 48.4 | — |
| SECONDARY Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale |
13; 5; 17; 9; 12; 9 | — |
| SECONDARY Number of Participants With Response Based on Physician's Global Assessment Scale |
41; 24; 6; 5; 40; 21 | — |
| SECONDARY Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale |
46; 25; 25; 21 | — |
| SECONDARY Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale |
9; 7; 10; 4 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12 |
5.4; 5.7; -2.4; -2.3 | — |
| SECONDARY Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 |
1.0; 1.2 | — |
| SECONDARY Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 |
0.1; 0.2 | — |
| SECONDARY Number of Participants With Awakenings Based on Sleep Questionnaire |
10; 6; 18; 6; 16; 10 | — |
| SECONDARY Number of Participants With Response Based on Overall Quality of Sleep Questionnaire |
1; 1; 37; 17; 19; 13 | — |
| SECONDARY Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 |
48.9; 51.9; 12.1; 3.4; 57.8; 57.1 | — |
| SECONDARY Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12 |
1.9; 1.7; -0.9; -0.4 | — |
| SECONDARY Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12 |
11.7; 12.7; -3.3; -1.8 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with chronic pain due to osteoarthritis of knee or low back pain continuing for at least 12 weeks before informed consent
- Participants who did not achieve adequate analgesia (pain control) with routine treatment with an oral non-opioid analgesic (drug used to control pain) at its usual upper-limit dose or at an adequate fixed dose for at least 14 consecutive days during the 12 weeks before informed consent
- Participants who have not experienced treatment with conventional opioids, except for short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent or temporary use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days before informed consent
- Participants with average pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale (NRS) during 48 hours before informed consent and are considered requiring opioid treatment by the Investigator
- Participants who are able to visit the medical institutions throughout the study period
Exclusion Criteria
- Participants who are taking a monoamine oxidase inhibitor within 14 days before informed consent
- Participants with current or a history of epilepsy or seizure disorders
- Participants suspected with intracranial hypertension (e.g. traumatic encephalopathy)
- Participants with uncontrolled or clinically significant arrhythmia (irregular heart rate)
- Participants with moderate to severe liver dysfunction or severe renal dysfunction
Data sourced from ClinicalTrials.gov (NCT01124604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.