An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Uncontrolled Severe Chronic Nociceptive, Mixed or Neuropathic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.

Grünenthal GmbH8 sites in 1 country208 target enrollmentSeptember 30, 2009

ConditionsChronic Pain Low Back Pain

InterventionsTapentadol PR Observation period

DrugsTapentadol PR

Overview

Phase: Phase 3
Intervention: Tapentadol PR
Conditions: Chronic Pain
Sponsor: Grünenthal GmbH
Enrollment: 208
Locations: 8
Primary Endpoint: The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline).
Status: Completed
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 either WHO Step I or Step II analgesics or no regular analgesics. 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 (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.

Registry

clinicaltrials.gov

Start Date

September 30, 2009

End Date

July 6, 2010

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.
•Participants were men or non-pregnant, non-lactating women. Female participants must be postmenopausal, surgically sterile, or practicing an effective method of birth control. 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.
•Participants's pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator.
•Participants must report a rate of satisfaction with their previous analgesic regimen not exceeding "fair" on a subject satisfaction with treatment scale (5-point VRS).
•If under regular, daily pretreatment:
•Participants must be taking a WHO Step I or Step II analgesic medication on a daily basis for at least 2 weeks prior to the Screening Visit.

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

Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol immediate release (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

Tapentadol

Intervention: Observation period

Outcomes

Primary Outcomes

The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline).

Time Frame: Baseline; End of Week 6 (6 Weeks)

For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity.

Secondary Outcomes

Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period(Baseline; End of Week 12 (12 weeks))
painDETECT Assessment at Baseline(Baseline)
Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline(Baseline Visit)
Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period(End of Week 6)
Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period(End of Week 12)
Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of Titration and Optimal Dose Period(Baseline; End of Week 6 (6 Weeks))
Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of the Maintenance Period(Baseline; End of Week 12 (12 Weeks))
Patient Global Impression of Change at End of Titration and Optimal Dose Period(Baseline; End of Week 6 (6 Weeks))
Patient Global Impression of Change at End of the Maintenance Period(Baseline; End of Week 12 (12 weeks))
EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period.(Baseline; End of Week 6 (6 weeks))
Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period.(Baseline; End of Week 6 (6 weeks))
Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period(Baseline; End of Week 6 (6 weeks))
painDETECT Assessment for Participants at End of Titration and Optimal Dose Period(End of Week 6)
painDETECT Assessment for Participants at End of the Maintenance Period(End of Week 12)
EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period(Baseline; End of Week 12 (12 weeks))
Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period(Baseline; End of Week 12 (12 weeks))
Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period(Baseline; End of Week 6 (6 weeks))
Clinical Global Impression of Change (All Participants) at End of Maintenance Period(Baseline; End of Week 12 (12 weeks))
Hospital Anxiety Depression Scale (HADS): Anxiety Score at Baseline(Baseline)
Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period(Baseline; End of Week 6 (6 weeks))
Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period(Baseline; End of Week 12 (12 Weeks))
Hospital Anxiety Depression Scale: Depression Score at Baseline(Baseline)
Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period.(Week 6)
Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period.(Baseline; End of Week 6 (6 weeks))
Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period(Baseline; End of Week 12 (12 Weeks))
Participant's Satisfaction With Previous Analgesic Treatment at Baseline(Baseline)
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period.(End of Week 6)
NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period.(End of Week 12)
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period.(End of Week 8)
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period.(End of Week 12)
Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline.(Baseline)
NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.(End of Week 6)
Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline.(Baseline)
NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.(End of Week 6)
NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period.(End of Week 12)