Phase 2
N=91
A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia
Pain · Diabetic Neuropathies · Neuralgia · Postherpetic Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT01124617 ↗Enrolled (actual)
91
Serious AEs
7.7%
Results posted
Jun 2013
Primary outcome: Primary: Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 — 6.7; 6.9; -2.6; -2.6 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tapentadol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Janssen Pharmaceutical K.K.
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 |
6.7; 6.9; -2.6; -2.6 | — |
| SECONDARY Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 |
-0.7; -0.2; -1.1; -0.9; -1.5; -1.1 | — |
| SECONDARY Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) |
48.3; 41.9; 33.3; 38.7 | — |
| SECONDARY Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale |
7; 4; 16; 7; 16; 10 | — |
| SECONDARY Number of Participants With Categorical Scores on Physician's Global Assessment Scale |
41; 19; 5; 7; 35; 20 | — |
| SECONDARY Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale |
4.7; 4.6; -2.6; -2.1 | — |
| SECONDARY Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale |
6.2; 6.3; -3.0; -2.6 | — |
| SECONDARY Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 |
5.2; 5.2; -2.7; -2.3 | — |
| SECONDARY Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 |
45.4; 34.7; -11.1; -3.1 | — |
| SECONDARY Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 |
5.8; 6.4; 0.3; 0.3 | — |
| SECONDARY Number of Participants With Awakenings Based on Sleep Questionnaire |
17; 3; 16; 9; 10; 10 | — |
| SECONDARY Number of Participants With Response Based on Overall Quality of Sleep Questionnaire |
0; 1; 35; 12; 22; 16 | — |
| SECONDARY Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 |
68.6; 61.0; 70.1; 64.3; 36.2; 38.8 | — |
Summary
The purpose of this study is to investigate the efficacy and safety of tapentadol extended-release (ER) tablets in Japanese participants with moderate to severe chronic (lasting a long time) pain due to painful diabetic peripheral neuropathy (pain in the extremities related to diabetes-induced nerve damage) or postherpetic neuralgia (pain lasting after condition has healed).
Eligibility Criteria
Inclusion Criteria
- Participants with chronic pain due to painful diabetic neuropathy or postherpetic neuralgia continuing for at least 12 weeks before consent
- Participants with adjuvant analgesics (antidepressants, antiepileptics and diabetic peripheral neuropathy drugs) or non-opioid treatment and dissatisfied with current treatment (in sense of efficacy and/or safety) for at least consecutive 14 days during the 12 weeks before consent
- Participants have not experienced treatment with conventional opioids, except for the following cases: Short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent; and temporal use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (for example, for antitussive) more than 2 days before consent
- Mean pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale during 48 hours before consent and the Investigator or Sub-investigator considers that the participant should be treated with an opioid analgesic
- HbA1c within 4 weeks before consent less than or equal to 11percent (in participants with diabetic neuropathic pain)
Exclusion Criteria
- Participants have been treated or treated with a monoamine oxidase inhibitor within 14 days before consent
- Current or a history of epilepsy or convulsive disorders or hypersensitivity to opioid analgesics
- Suggested of intracranial hypertension (for example, traumatic encephalopathy)
- Participants who have complicated condition with uncontrolled or clinically significant arrhythmia, or neuropsychiatric disorders
- Participants with moderately to severely impaired hepatic function, or severely impaired renal function
Data sourced from ClinicalTrials.gov (NCT01124617). 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.