Clinical Trial: Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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

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.


Detailed Summary:
Sponsor: Grünenthal GmbH

Current Primary Outcome: 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 as with their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1.


Original Primary Outcome: The primary outcome is the percentage of subjects with the same or less pain (on the NRS-3) at Week 6 compared with Week -1. [ Time Frame: 7 weeks ]

Current Secondary Outcome:

  • Average Pain Intensity Before the Start of Tapentadol Treatment [ Time Frame: Baseline ]
    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".
  • Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment. [ 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 value on the 0 to 10 scale. A negative value indicates a reduction in pain intensity from the baseline average pain intensity.
  • Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment. [ Time Frame: Baseline; End of Week 12 (12 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 value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity.
  • Patient Global Impression of Change [ Time Frame: Baseline; End of Week 6 (6 Weeks) ]
    In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.
  • Patient Global Impression of Change [ Time Frame: Baseline; End of Week 12 (12 Weeks) ]
    In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.
  • Change in the Health Survey Scores Form (SF-36) [ Time Frame: Baseline; End of Week 6 (6 Weeks) ]
    The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.
  • Change in the Health Survey Scores Form (SF-36) [ Time Frame: Baseline; End of Week 12 (12 Weeks) ]
    The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.
  • Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score [ Time Frame: Baseline ]

    All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.

    Results are reported as the mean for each neuropathic symptom in the sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group).

  • Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score [ Time Frame: End of Week 6 ]

    All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.

    Results are reported as the mean for each neuropathic symptom in a sub-scale. The mean score is

    Original Secondary Outcome: Changes from baseline of: 11-point NRS-3 pain intensity, Sleep Evaluation Questionnaire (SQ) items, Short Form 36 Health Survey (SF-36) scores, EuroQoL-5 Dimension (EQ- 5D) scores, Hospital Anxiety and Depression Scale (HADS). [ Time Frame: 13 weeks ]

    Information By: Grünenthal GmbH

    Dates:
    Date Received: September 28, 2009
    Date Started: October 2009
    Date Completion:
    Last Updated: May 9, 2014
    Last Verified: May 2014