An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Severe Chronic Nociceptive, Mixed or Neuropathic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability

Grünenthal GmbH27 sites in 8 countries136 target enrollmentOctober 30, 2009

ConditionsPain Chronic Pain Low Back Pain Neuropathic Pain Nociceptive Pain

InterventionsTapentadol Prolonged Release

DrugsTapentadol Prolonged Release

Overview

Phase: Phase 3
Intervention: Tapentadol Prolonged Release
Conditions: Pain
Sponsor: Grünenthal GmbH
Enrollment: 136
Locations: 27
Primary Endpoint: Number of Participants That Responded to Treatment
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking WHO Step III analgesics and show lack of tolerability. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.

The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with that of tapentadol hydrochloride prolonged release treatment during defined periods of evaluation.

Registry

clinicaltrials.gov

Start Date

October 30, 2009

End Date

January 2011

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Grünenthal GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants must have signed an Informed Consent Form indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it.
•Participants are men or non-pregnant, non-lactating women. Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Women of childbearing potential must have a negative pregnancy test at screening.
•Participants must be appropriately communicative to verbalize and to differentiate with regard to location and intensity of the pain.
•Participants must be at least 18 years of age.
•Participants must have a diagnosis of chronic low back pain; chronic pain defined as pain lasting for at least 3 months
•If the Participant has radicular pain, this must have been present for at least 3 months and stable for the 4 weeks before enrollment.
•Participant's pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator.
•Participants must be taking a WHO Step III analgesic on a daily basis for at least 3 months prior to the Screening Visit.
•Participants must have responded to the WHO Step III analgesic, i.e., participants must have a confirmed average pain intensity score (NRS 3) of ≤5 points during the last 3 days prior to the Screening Visit.
•Participants must report opioid-related side effects as the reason to change their analgesic.

Exclusion Criteria

•Presence of a clinically significant disease or laboratory findings that in the Investigator's opinion may affect efficacy or safety assessments.
•Presence of active systemic or local infection that may, in the opinion of the Investigator, affect the efficacy, quality of life/function or safety assessments.
•History of alcohol or drug abuse, or suspicion of in Investigator's judgement.
•Presence of concomitant autoimmune inflammatory conditions.
•Known history of or laboratory values reflecting severe renal impairment.
•Known history of moderately or severely impaired hepatic function.
•History of or active hepatitis B or C within the past 3 months or history of HIV infection.
•History of seizure disorder or epilepsy.
•Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. 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 h) or residual sequelae suggesting transient changes in consciousness.
•Pregnant or breast-feeding.

Arms & Interventions

Tapentadol Prolonged Release

Other Names: * Nucynta * Palexia

Intervention: Tapentadol Prolonged Release

Outcomes

Primary Outcomes

Number of Participants That Responded to Treatment

Time Frame: 6 weeks

Participants were considered responders if they reported the same or less average pain intensity over a 3 day period (NRS-3) after 6 weeks of tapentadol prolonged release treatment compared to their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1.

Secondary Outcomes

Average Pain Intensity Before the Start of Tapentadol Treatment(Baseline)
Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment.(Baseline; End of Week 6 (6 weeks))
Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment.(Baseline; End of Week 12 (12 weeks))
Patient Global Impression of Change(Baseline; End of Week 12 (12 Weeks))
Change in the Health Survey Scores Form (SF-36)(Baseline; End of Week 12 (12 Weeks))
Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score(End of Week 12)
Mean Equipotency Ratio of Tapentadol Compared to Oxycodone(Baseline; End of Week 6 (6 Weeks))
Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine(Baseline; End of Week 6 (6 Weeks))
Mean Equipotency Ratio of Tapentadol Compared to Fentanyl(Baseline; End of Week 6 (6 Weeks))
Mean Equipotency Ratio of Tapentadol Compared to Morphine(Baseline; End of Week 6 (6 Weeks))
Mean Equipotency Ratio of Tapentadol Compared to Hydromorphone(Baseline; End of Week 6 (6 Weeks))
painDETECT Assessment at Baseline(Baseline)
painDETECT Assessment for Participants After 6 Weeks of Tapentadol Prolonged Release Treatment(End of Week 6)
painDETECT Assessment for Participants After 12 Weeks of Tapentadol Prolonged Release Treatment(End of Week 12)