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
Information source: GrŁnenthal GmbH
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pain Due to Low Back Pain
Intervention: Tapentadol (Drug)
Phase: Phase 3
Sponsored by: GrŁnenthal GmbH
Official(s) and/or principal investigator(s):
Michael Sch√§fer, Prof. MD, Principal Investigator, Affiliation: Charit√© University Berlin, Campus Virchow Klinikum
Claudia Leinweber, Email: Clinical-Trials@grunenthal.com
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
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.
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, Mixed or Neuropathic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability
Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
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).
Minimum age: 18 Years.
Maximum age: N/A.
- Subjects 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
- Subjects 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.
- Subjects must be appropriately communicative to verbalize and to differentiate with
regard to location and intensity of the pain.
- Subjects must be at least 18 years of age.
- Subjects must have a diagnosis of chronic low back pain; chronic pain defined as pain
lasting for at least 3 months
- If the subject has radicular pain, this must have been present for at least 3 months
and stable for the 4 weeks before enrollment.
- Subject's pain must require a strong analgesic (defined as WHO Step III) as judged by
- Subjects must be taking a WHO Step III analgesic on a daily basis for at least 2
weeks prior to the Screening Visit.
- Subjects must have responded to the WHO Step III analgesic, i. e., subjects must have
a confirmed average pain intensity score (NRS 3) of ‚Č§5 points during the last 3 days
prior to the Screening Visit.
- Subjects must report opioid-related side effects as the reason to change their
- Subjects must report a rate of satisfaction with their previous analgesic regimen not
exceeding "fair" on a subject satisfaction with treatment scale (5-point VRS).
- 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
- 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
- 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). Key exclusion
criteria (trial specific) - at the Screening Visit
- 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.
Locations and Contacts
Claudia Leinweber, Email: Clinical-Trials@grunenthal.com
Site 1, Newcastle, Australia; Completed
Site 2, Perth, Australia; Recruiting
Site 4, Brugges, Belgium; Recruiting
Site 5, Brussels, Belgium; Completed
Site 3, Charleroi, Belgium; Completed
Site 2, Edegem, Belgium; Recruiting
Site 1, Li√®ge, Belgium; Recruiting
Site 1, Brno, Czech Republic; Recruiting
Site 3, Olomouc, Czech Republic; Completed
Site 2, Ostrava, Czech Republic; Completed
Site 2, Montpellier, France; Completed
Site 3, Orl√©ans, France; Completed
Site 4, Thionville, France; Recruiting
Site 1, Toulouse, France; Recruiting
Site 5, Albstadt, Germany; Recruiting
Site 1, Berlin, Germany; Recruiting
Site 2, Berlin, Germany; Not yet recruiting
Site 3, Berlin, Germany; Recruiting
Site 6, Kiel, Germany; Recruiting
Site 4, Leipzig, Germany; Recruiting
Site 8, Leipzig, Germany; Not yet recruiting
Site 7, Stuttgart, Germany; Recruiting
Site 2, Alkmaar, Netherlands; Recruiting
Site 4, Doetinchem, Netherlands; Recruiting
Site 3, Eindhoven, Netherlands; Recruiting
Site 5, Stadskanaal, Netherlands; Completed
Site 1, Tiel, Netherlands; Recruiting
Site 2, Krakow, Poland; Recruiting
Site 1, Poznan, Poland; Recruiting
Site 4, Wroclaw, Poland; Completed
Site 6, Cadiz, Spain; Recruiting
Site 1, Granada, Spain; Recruiting
Site 3, Malaga, Spain; Recruiting
Site 4, Sevilla, Spain; Recruiting
Site 5, Valencia, Spain; Recruiting
Site 1, Basel, Switzerland; Recruiting
Site 2, St. Gallen, Switzerland; Recruiting
Starting date: September 2009
Last updated: June 7, 2010