Phase 2
Completed N=78
Phase 2 Study of Tapentadol Prolonged Release in Cancer Pain Participants
Source: ClinicalTrials.gov NCT00805142 ↗Enrolled (actual)
78
Serious AEs
10.3%
Results posted
Jul 2013
Primary outcomePrimary: Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase — 89.7; 92.9 percentage of participants
Summary
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time; explores what the body does to the drug) of tapentadol prolonged release (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and spreads in the body until it kills) pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Pain Control for 5 Day Fixed Dose Phase |
89.7; 92.9 | — |
| SECONDARY Percentage of Participants Who Achieve Dose Adjustment |
93.3; 80.6 | — |
| SECONDARY Pain Assessment Using 24-hour Numerical Rating Scores (NRS) Scale |
4.9; 1.3; 2.4; 1.7 | — |
| SECONDARY Pain Assessment Using Visual Analog Scale (VAS) Score |
44.34; 10.71; 20.33; 10.30 | — |
| SECONDARY Rescue Doses |
0.34; 1.07; 0.52; 1.16; 1.03; 1.61 | — |
| SECONDARY Number of Participants Who Discontinued Study Treatment Because of Any Adverse Event (AE) or Lack of Efficacy |
2; 3; 0; 1 | — |
| SECONDARY Sleep Questionnaire Regarding Time to Sleep and Total Time Slept |
47.10; 63.80; 43.10; 56.60; 371.70; 390.50 | — |
| SECONDARY Sleep Questionnaire Regarding Number of Awakenings |
2.40; 3.40; 2.20; 3.80 | — |
| SECONDARY Sleep Questionnaire Regarding the Quality of Sleep |
1; 0; 4; 2; 16; 20 | — |
| SECONDARY Patient's Global Impression of Change (PGI-C) |
1; 0; 13; 1; 10; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Opioid switching participants should meet the following criteria from a to c: a) Participants with cancer pain b) previously were on opioid medications (morphine sustained release preparations [120 milligram per day {mg/day} or less], oxycodone hydrochloride sustained release tablets [80 mg/day or less], fentanyl transdermal [through the skin] application system [4.2 mg or less]) c) had achieved adequate pain control with opioid therapy
- Opioid naive participants should meet the following criteria from a to b: a) Participants with cancer pain b) should not have received any pain control therapy with opioids (excluding narcotic antagonist analgesics [drug used to control pain])
- Definite diagnosis of any type of cancer, which has been notified to the participant
- Participants who can be hospitalized during the treatment period
- Participant who can record 11 point Numerical Rating Scale (NRS) and 100 millimeter (mm) Visual Analog Scale (VAS) scores appropriately throughout the study
Exclusion Criteria
- Participants with bradyarrhythmia (slow, irregular heartbeats)
- History of mild or moderate traumatic (causing damage, like a toll used to crush tissue) encephalopathy, cerebral (having to do with the cerebrum) infarction (death of tissue because of lack of blood supply) or transient ischemic (decreased oxygen in a tissue [usually because of decreased blood flow]) attack within 1 year before informed consent
- Previous or concurrent epilepsy (seizure disorder) or convulsive diseases accompanied by disturbance of consciousness
- Previous or concurrent alcohol dependence or narcotic abuse
- History of active hepatitis (inflammation of the liver) B or C within 3 months before informed consent
Data sourced from ClinicalTrials.gov (NCT00805142). 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.