Comparison of tapentadol PR and oxycodone/naloxone PR

• Conditions: Severe chronic low back pain with a neuropathic pain component; MedDRA version: 15.1Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852; MedDRA version: 15.1Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-002943-11-IT
• Lead Sponsor: Grünenthal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-28
• Last Update Posted: 26 November 2013

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
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified