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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grünenthal GmbH
ClinicalTrials.gov Identifier:
NCT01352741
First received: April 12, 2011
Last updated: August 9, 2012
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Neuropathic Pain
Drug: Tapentadol PR
Drug: Tapentadol PR with Pregabalin
Drug: Tapentadol PR open label maintenance
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Grünenthal GmbH:

Primary Outcome Measures:
  • 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of the pain intensity score on an 11- point Numeric Rating Scale(NRS)-3 [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
  • painDetect® score [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
  • NRS-3 pain intensity score for pain radiating towards or into the leg [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
  • Worst pain (11-point NRS) during the last 24 hours [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
  • Subject's satisfaction with treatment [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
    Subject's satisfaction with treatment (5-point rating scale)

  • Patient's Global Impression of Change (PGIC). [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Clinician's Global Impression of Change (CGIC). [ Time Frame: up to 11 weeks ] [ Designated as safety issue: No ]
  • Neuropathic Pain Symptoms Inventory (NPSI). [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
  • Sleep Evaluation Questionnaire (SQ) items. [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS). [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
  • Change over time of the Short Form-12® Health Survey (SF-12®) scores as a Measure of Quality of Life and Function. [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
  • Change over time of the EuroQol-5 Dimension (EQ 5D) scores as a Measure of Quality of Life and Function. [ Time Frame: up to 13 weeks ] [ Designated as safety issue: No ]
  • Number of Adverse events and adverse events at least possibly related to the IMP as a measure of quality of Tolerability and Safety [ Time Frame: up to 13 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 622
Study Start Date: March 2011
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tapentadol PR
Tapentadol PR (100 - 500 mg per day) Oral administration twice daily
Drug: Tapentadol PR
100 - 500 mg per day orally twice daily for a maximum of 12 weeks
Drug: Tapentadol PR open label maintenance
100 - 400 mg per day Tapentadol PR orally administered twice daily
Active Comparator: Tapentadol PR with Pregabalin
Tapentadol PR (100 - 300 mg per day) with Pregabalin (150 - 300 mg per day) Both administered orally twice a day.
Drug: Tapentadol PR with Pregabalin
Tapentadol PR 100 - 300 mg per day with Pregabalin 150 - 300 mg per day orally twice daily for a maximum of 12 weeks
Drug: Tapentadol PR open label maintenance
100 - 400 mg per day Tapentadol PR orally administered twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352741

  Show 58 Study Locations
Sponsors and Collaborators
Grünenthal GmbH
Investigators
Principal Investigator: Ralf Baron, Prof. Dr. Neurological pain research and therapy Clinic for Neurology Campus Kiel, University Clinic Schleswig-Holstein, Schittenhelmstr. 10, 24105 Kiel, Germany
  More Information

No publications provided

Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT01352741     History of Changes
Other Study ID Numbers: 247251
Study First Received: April 12, 2011
Last Updated: August 9, 2012
Health Authority: Austria: BASG (Bundesamt für Sicherheit im Gesundheitswesen)(Austrian Federeal Office for Safety in Health care)
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: The Danish Medicines Agency
Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) (Federal Institute for Drugs and Medical Devices)
Poland: CEBK (Centralna Ewidencja Badán Klinicznych) (Central Register of Clinical Trials)
The Netherlands: MEB (Medicines Evaluation Board)
Romania: National Medicines Agency
Spain: AEMPS (AGencia Espanola de Medicamentos y Productos Sanitarios)

Keywords provided by Grünenthal GmbH:
low back pain
neuropathic
pain assessment
centrally acting tapentadol pregabalin
severe chronic

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 20, 2014