Comparison of tapentadol PR and oxycodone/naloxone PR

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

1. Informed consent signed.
2. Male or female subject =18 years of age.
3. Women of childbearing potential must have a negative pregnancy test at the Enrollment Visit.
4. Women of childbearing potential must practice medically acceptable
methods of birth control during the trial.
5. Subjects must be appropriately communicative and able to differentiate with regard to location and intensity of the pain, and to complete the questionnaires used in this trial.
6. Subjects must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months prior to enrollment.
7. Subject’s pain must require a strong analgesic (defined as WHO Step III) as judged by the investigator.
8. Subjects who require a washout of co-analgesics at enrollment must have an average pain score (NRS-3) of 5 points or higher.
Subjects who do not require a washout of co-analgesics at enrollment must have an average pain intensity score (NRS-3) of 6 points or higher.
9. The painDETECT diagnostic screening questionnaire must be either positive” (= score of 19 to 38 inclusive) or unclear” (= score of 13 to 18 inclusive) or If the subject is being treated with a stable regimen of centrally acting co-analgesics, a negative” painDETECT scorescore (but 9 points or higher) at the Enrollment Visit will be acceptable
Inclusion criteria at the Randomization Visit
10. Subjects must have an average pain intensity score (NRS-3) of 6 points or higher.
11. Subjects must score either positive” (= score of 19 to 38 inclusive) or unclear” (= score of 13 to 18 inclusive) on the painDETECT diagnostic screening questionnaire.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

1. Presence of a clinically significant disease or clinical laboratory values that in the investigator’s opinion may affect effectiveness, quality of life, or safety/tolerability assessments
2. Presences of active systemic or local infections that may, in the opinion of the investigator, affect the effectiveness, quality of life, or safety/tolerability assessments.
3. Employees of the investigator or trial site, with direct involvement in this trial or other trials under the direction of the investigator or trial site, as well as family members of employees of the investigator.
4. Participation in another trial concurrently, or within 4 weeks prior to the Enrollment Visit.
5. Known to or suspected of not being able to comply with the protocol and/or appropriate use of the IMPs.
6. Any painful procedures (e.g., major surgery) scheduled during the trial duration (Enrollment Visit until Final Evaluation Visit) that may, in the opinion of the investigator, affect the effectiveness, quality of life, or safety assessments.
7. Pending litigation or application for insurance/governmental benefits due to chronic pain or disability and/or if the granted benefits might be influenced by a successful participation in the trial.
8. Low back pain caused by cancer and/or metastatic diseases.
9. History of alcohol or drug abuse, or suspicion thereof in the investigator’s judgment.
10. Presence of concomitant autoimmune inflammatory conditions.
11. Subjects with acute intoxication with alcohol, hypnotics, centrally acting analgesics, or psychotropic active substances.
12. Subjects with severe renal impairment, i.e., estimated glomerular filtration rate less than 30 mL/min (according to the National Kidney Foundation 2002).
13. Known history of clinical laboratory values or current clinical laboratory values reflecting moderately or severely impaired hepatic function.
14. History of seizure disorder or epilepsy.
15. Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm (including brain metastases if present at the Enrollment Visit). Severe traumatic brain injury within 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting more than 24 hours) or residual sequelae.
16. Pregnant or breast-feeding women.
17. Severe respiratory depression with hypoxia and/or hypercapnia, acute or severe bronchial asthma or severe chronic obstructive pulmonary disease.
18. Presence or suspicion of paralytic ileus.
19. Subjects with severe cardiac impairment, e.g., New York Heart Association class >3, myocardial infarction less than 6 months prior to the Enrollment Visit, and/or unstable angina pectoris and/or cor pulmonale.
20. Subjects with known history of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
21. History of allergy or hypersensitivity to tapentadol, oxycodone, naloxone, and their formulations.
22. Subjects with acute biliary obstruction or acute pancreatitis.
23. Subjects with hypothyroidism (including myxedema) or Addison’s disease.
24. Subjects taking any prohibited concomitant medication.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus a combination of tapentadol PR and pregabalin in subjects with severe chronic low back pain with a neuropathic pain component

Phase 1

Grünenthal GmbH

Updated 8/21/2017