Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin

Condition(s) targeted: Low Back Pain; Neuropathic Pain

Intervention: Tapentadol PR (Drug); Tapentadol PR with Pregabalin (Drug); Tapentadol PR open label maintenance (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Grünenthal GmbH

Official(s) and/or principal investigator(s):
Ralf Baron, Prof. Dr., Principal Investigator, Affiliation: Neurological pain research and therapy Clinic for Neurology Campus Kiel, University Clinic Schleswig-Holstein, Schittenhelmstr. 10, 24105 Kiel, Germany

Overall contact:
Claudia Leinweber, Email: Clinical-Trials@grunenthal.com

The main objective of the study is to evaluate the effectiveness, safety, and tolerability of increasing doses of tapentadol prolonged release (PR) (500 mg per day) versus a combination of tapentadol PR (300 mg per day) and pregabalin (to 300 mg per day) in subjects requiring additional analgesia after titration to tapentadol PR 300 mg per day.

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 outcomes. Since, severe low back pain with a neuropathic component, the targeted study population, is frequently treated with a combination therapy (monotherapy is often not effective enough) it is of interest to determine if tapentadol alone (combining 2 mechanisms of action in a single molecule) could be as effective as a combination of tapentadol plus pregabalin. Furthermore, the tolerability profiles of monotherapy versus combination are of interest.

Official title: Evaluation of the Effectiveness, Safety, and Tolerability of Tapentadol PR Versus a Combination of Tapentadol PR and Pregabalin in Subjects With Severe Chronic Low Back Pain With a Neuropathic Pain Component

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Comparison of tapentadol PR 500 mg per day and the combination of tapentadol PR 300 mg per day and pregabalin 300 mg per day regarding the change in NRS-3 pain intensity scores from the randomization visit to the final evaluation visit.

Secondary outcome:

Change of the pain intensity score on an 11- point Numeric Rating Scale(NRS)-3

painDetect® score

NRS-3 pain intensity score for pain radiating towards or into the leg

Worst pain (11-point NRS) during the last 24 hours

Subject's satisfaction with treatment

Patient's Global Impression of Change (PGIC).

Clinician's Global Impression of Change (CGIC).

Neuropathic Pain Symptoms Inventory (NPSI).

Sleep Evaluation Questionnaire (SQ) items.

Hospital Anxiety and Depression Scale (HADS).

Change over time of the Short Form-12® Health Survey (SF-12®) scores as a Measure of Quality of Life and Function.

Change over time of the EuroQol-5 Dimension (EQ 5D) scores as a Measure of Quality of Life and Function.

Number of Adverse events and adverse events at least possibly related to the IMP as a measure of quality of Tolerability and Safety

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects must have a diagnosis of chronic low back pain; chronic pain defined as pain

lasting for at least 3 months.

- Subject's pain must require a strong analgesic (defined as World Health Organization

(WHO) step III) as judged by the investigator.

- The painDETECT diagnostic screening questionnaire score must be:

- "positive" or

- "unclear".or If the subject is being treated with a stable regimen of centrally

acting analgesics (opioids) and/or co-analgesics, even a "negative" painDETECT score (but of at least 9) at the enrollment visit will be acceptable.

- If under regular daily pretreatment with a WHO step II/step III opioid analgesic

and/or a centrally acting co-analgesic:

- Subjects must be taking a WHO step II or step III analgesic or co- analgesic on

a daily basis for at least 2 weeks prior to the enrollment visit.

- Subjects pretreated with a WHO step II opioid analgesic and/or a centrally

acting co-analgesic must have reported an average pain intensity score of at least 5 points (NRS-3≥5) during the last 3 days prior to the enrollment visit. or If under regular, daily pretreatment with a WHO step I analgesic monotherapy or if no regular analgesic pretreatment is reported:

- Subjects must have an average pain intensity score of at least 6 points NRS-3≥6)

in the last 3 days prior to the enrollment visit.

Exclusion Criteria:

- Presence of concomitant painful conditions other than low back pain that could

confound the subject's trial assessments or self-evaluation of the index pain, e. g., syndromes with widespread pain such as fibromyalgia.

- Low back pain caused by cancer and/or metastatic diseases.

- Any painful procedures planned during the trial period (e. g., major surgery) that

may, in the opinion of the investigator, affect the effectiveness or safety assessments of the Investigational Medicinal Product (IMP).

- Pending litigation or application for insurance/governmental benefits due to chronic

pain or disability and, if granted, benefits might be influenced by a successful participation in the trial.

- Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or

glucose-galactose malabsorption, lactose intolerance.

Claudia Leinweber, Email: Clinical-Trials@grunenthal.com

Site 506, Klagenfurt, Austria; Not yet recruiting

Site 503, Senftenberg, Austria; Recruiting

Site 501, Wien, Austria; Recruiting

Site 502, Wien, Austria; Not yet recruiting

Site 505, Wien, Austria; Not yet recruiting

Site 504, Wien, Austria; Not yet recruiting

Site 605, Dour, Belgium; Not yet recruiting

Site 602, Genk, Belgium; Not yet recruiting

Site 603, Gozee, Belgium; Not yet recruiting

Site 604, Ham, Belgium; Not yet recruiting

Site 601, Pellenberg, Belgium; Not yet recruiting

Site 702, Copenhagen, Denmark; Not yet recruiting

Site 704, Frederiksberg, Denmark; Not yet recruiting

Site 701, Glostrup, Denmark; Not yet recruiting

Site 703, Ringsted, Denmark; Not yet recruiting

Site 107, Berlin, Germany; Not yet recruiting

Site 111, Böhlen, Germany; Not yet recruiting

Site 115, Cottbus, Germany; Not yet recruiting

Site 103, Hamburg, Germany; Not yet recruiting

Site 110, Hamburg, Germany; Not yet recruiting

Site 101, Kiel, Germany; Not yet recruiting

Site 114, Kiel, Germany; Not yet recruiting

Site 116, Köln, Germany; Not yet recruiting

Site 105, Köln, Germany; Not yet recruiting

Site 113, Leipzig, Germany; Not yet recruiting

Site 109, Lübeck, Germany; Not yet recruiting

Site 106, Rendsburg, Germany; Not yet recruiting

Site 108, Schönau, Germany; Not yet recruiting

Site 117, Weimar, Germany; Not yet recruiting

Site 112, Westerede, Germany; Not yet recruiting

Site 104, Wiesbaden, Germany; Not yet recruiting

Site 803, Amsterdam, Netherlands; Not yet recruiting

Site 804, Eindhoven, Netherlands; Not yet recruiting

Site 805, Enschede, Netherlands; Not yet recruiting

Site 802, Heerenveen, Netherlands; Not yet recruiting

Site 801, Sliedrecht, Netherlands; Not yet recruiting

Site 309, Bydgoszcz, Poland; Not yet recruiting

Site 312, Gdansk, Poland; Not yet recruiting

Site 303, Katowice, Poland; Not yet recruiting

Site 311, Krakow, Poland; Not yet recruiting

Site 310, Krakow, Poland; Not yet recruiting

Site 308, Krakow, Poland; Not yet recruiting

Site 307, Lublin, Poland; Not yet recruiting

Site 306, Mazowiecka, Poland; Not yet recruiting

Site 304, Poznan, Poland; Not yet recruiting

Site 301, Warsaw, Poland; Not yet recruiting

Site 302, Warszawa, Poland; Not yet recruiting

Site 305, Wroclaw, Poland; Not yet recruiting

Site 401, Bucharest, Romania; Not yet recruiting

Site 402, Bucharest, Romania; Not yet recruiting

Site 403, Bucharest, Romania; Not yet recruiting

Site 408, Bucharest, Romania; Not yet recruiting

Site 406, Bucharest, Romania; Not yet recruiting

Site 407, Bucharest, Romania; Not yet recruiting

Site 404, Cluj-Napoca, Romania; Not yet recruiting

Site 405, Iasi, Romania; Not yet recruiting

Site 904, A Coruna, Spain; Not yet recruiting

Site 908, Alicante, Spain; Not yet recruiting

Site 901, Badalona, Spain; Not yet recruiting

Site 905, Barcelona, Spain; Not yet recruiting

Site 902, Centelles, Spain; Not yet recruiting

Site 907, Granada, Spain; Not yet recruiting

Site 909, Madrid, Spain; Not yet recruiting

Site 910, Madrid, Spain; Not yet recruiting

Site 903, Oviedo, Spain; Not yet recruiting

Site 911, Valencia, Spain; Not yet recruiting

Starting date: March 2011
Last updated: May 11, 2011