An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Severe Chronic Pain Due to Osteoarthritis of the Knee Taking WHO Step III Analgesics But Showing a Lack of Tolerability.

Grünenthal GmbH10 sites in 4 countries82 target enrollmentSeptember 2009

ConditionsChronic Pain Osteoarthritis

InterventionsTapentadol PR

DrugsTapentadol PR

Overview

Phase: Phase 3
Intervention: Tapentadol PR
Conditions: Chronic Pain
Sponsor: Grünenthal GmbH
Enrollment: 82
Locations: 10
Primary Endpoint: Responder Rate
Status: Terminated
Last Updated: 6 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 (PR) in participants suffering from severe chronic pain due to osteoarthritis of the knee 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 PR treatment during defined periods of evaluation.

Detailed Description

The trial will last up to 13 weeks for each subject and includes: * One week of observation under previous analgesic treatment. * Twelve weeks of treatment with tapentadol hydrochloride PR.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

August 2010

Last Updated

6 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 40 years of age.
•Participants must have a diagnosis of osteoarthritis of the knee based on the American College of Rheumatology (ACR) Classification criteria:
•Knee pain and
•Radiographic osteophytes or
•Knee pain and aged 40 years or above and
•Morning stiffness of less than 30 minutes of duration and
•Crepitus on motion.

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 thereof 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

Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol IR tablets per day, with a minimum of a 4 hour interval between doses, were taken if there were acute pain episodes. The total daily dose of Tapentadol PR and IR were not permitted to exceed 500 mg per day.

Intervention: Tapentadol PR

Outcomes

Primary Outcomes

Responder Rate

Time Frame: 6 weeks

Participants were considered responders if they reported the same or less average pain intensity over a 3 day period after 6 weeks of tapentadol PR treatment as with their previous analgesic treatment.

Secondary Outcomes

Average Pain Intensity Before the Start of Tapentadol Treatment(Baseline)
Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment.(Baseline; Week 12 (12 weeks))
Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee(Baseline)
Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment.(Baseline; 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 Oxycodone(Baseline; End of Week 6 (6 Weeks))
Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 6(6 weeks)
Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 12(12 weeks)
EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time(12 weeks)
Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)(12 Weeks)
Clinical Global Impression of Change(Baseline; End of Week 12 (12 Weeks))
Patient Global Impression of Change(Baseline; End of Week 12 (12 Weeks))
Participant's Satisfaction With Previous Analgesic Treatment.(Baseline)
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.(After 12 weeks)