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
Condition: Pain; Chronic Pain; Low Back Pain; Neuropathic Pain; Nociceptive Pain
MeSH terms: Neuralgia; Back Pain; Low Back Pain; Chronic Pain; Nociceptive Pain
Intervention: Tapentadol Prolonged Release
Intervention description: Participants started with 50 mg, 100 mg or 150 mg tapentadol prolonged release (PR) twice daily. Opioid rotation to tapentadol was scheduled as follows:
if less than 100 mg morphine equivalent start with 50 mg tapentadol PR;
if on 101 to 160 mg morphine equivalent daily dose start with 100 mg tapentadol PR;
if above 161 mg morphine equivalent daily dose start with 150 mg tapentadol PR.
Tapentadol doses were adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis). After 5 weeks, the doses of tapentadol PR were kept stable (start of Maintenance phase). The tapentadol PR formulation was administered for up to 12 weeks. Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release any more when a daily dose of 500 mg tapentadol PR was reached.
Intervention MeSH terms: Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pain assessment; tapentadol; centrally acting analgesic

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.
    

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.

          -  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).

        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.

          -  History of allergy to, or hypersensitivity to tapentadol hydrochloride or its
             excipients, or contraindications related to tapentadol hydrochloride including:

          -  Subjects with acute or severe bronchial asthma or hypercapnia.

          -  Subjects who have or are suspected of having paralytic ileus.

          -  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.

          -  Participation in another trial concurrently or within 4 weeks prior to the Screening
             Visit.

          -  Known to or suspected of not being able to comply with the protocol and the use of the
             investigational medicinal product.

          -  Use of monoamine oxidase inhibitors within 14 days before the Screening Visit.

          -  Non-stable dosing of selective serotonin reuptake inhibitors within 30 days before the
             Screening Visit (the doses must remain stable during the trial).

          -  Presence of concomitant painful condition other than low back pain that could confound
             the subject's trial assessments or self evaluation of pain, e.g., anatomical
             deformities, significant skin conditions such as abscess or syndromes with widespread
             pain such as fibromyalgia.

          -  Any painful procedures during the trial (e.g., major surgery) that may, in the opinion
             of the Investigator, affect the efficacy or safety assessments.

          -  Pending litigation due to chronic pain or disability.