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Clinical Trials/EUCTR2012-002943-11-IT
EUCTR2012-002943-11-IT
Active, not recruiting
Not Applicable

Evaluation of the effectiveness, safety, and tolerability of tapentadol PRversus oxycodone/naloxone PR in non-opioid pre-treated subjects withuncontrolled severe chronic low back pain with a neuropathic paincomponent.

Grünenthal GmbH0 sites240 target enrollmentJanuary 28, 2013
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DrugsPalexia retard 50 mgPalexia retard 100 mgTargin 10 mg / 5 mg RetardtablettenTargin 20 mg / 10 mg RetardtablettenTargin 40 mg / 20 mg RetardtablettenOxygesic 10 mg Retardtabletten

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Grünenthal GmbH
Enrollment
240
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 28, 2013
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

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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 componentsevere chronic low back pain with a neuropathic pain componentMedDRA version: 12.1Level: LLTClassification code 10024891Term: Low back painMedDRA version: 12.1Level: LLTClassification code 10054095Term: Neuropathic pain
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Comparison of increasing doses of tapentadol vs a combination of tapentadol and pregabaliSevere chronic low back pain with a neuropathic pain componentMedDRA version: 14.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
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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 componenternstig chronische lage rugpijn met een neuropatische componentneuropatic pain and low back pain
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