Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics

NCT00983385 | Completed Phase 3 Results

• 3 other identifiers: 7875792009-010427-12KF5503/44
• Study Type: interventional
• Target: 208
• Locations: 9 countries
• Sites: 46

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 either WHO Step I or Step II analgesics or no regular analgesics. 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 (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.

Conditions

Chronic Pain; Low Back Pain

Keywords

low back pain; pain; assessment; tapentadol; centrally acting analgesic

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (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". The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity.

  Baseline; End of Week 6 (6 Weeks)

Secondary Outcomes (35)

• Patient Global Impression of Change at End of Titration and Optimal Dose Period

  Baseline; End of Week 6 (6 Weeks)

• Patient Global Impression of Change at End of the Maintenance Period

  Baseline; End of Week 12 (12 weeks)

• Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period

  Baseline; End of Week 6 (6 weeks)

• Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period

  Baseline; End of Week 12 (12 weeks)

• painDETECT Assessment at Baseline

  Baseline

Study Arms (1)

Tapentadol

EXPERIMENTAL

Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol immediate release (IR) tablets per day, with a minimum of a 4 hour interval between doses, were taken if there were acute pain episodes. The total daily dose of Tapentadol PR and IR were not permitted to exceed 500 mg per day.

Drug: Tapentadol PR; Other: Observation period

Interventions

Tapentadol PR DRUG

Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg Tapentadol PR twice daily, adjusted with 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed a dose of 500 mg of Tapentadol per day.

Also known as: Palexia®, Nucynta®

Tapentadol

Observation period OTHER

Eligibility assessment period to characterize the baseline over a one week period (week -1). Participants continued their previous treatment prior to allocation to tapentadol, if eligible.

Tapentadol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have signed an Informed Consent Form.
• Participants were men or non-pregnant, non-lactating women. Female participants must be postmenopausal, surgically sterile, or practicing an effective method of birth control. 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.
• Participants's pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator.
• 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).
• If under regular, daily pretreatment:
• Participants must be taking a WHO Step I or Step II analgesic medication on a daily basis for at least 2 weeks prior to the Screening Visit.
• The Investigator considers dose increase of WHO Step I analgesics (as mono- or combination therapy) and/or continuation with or dose increase of WHO Step II analgesics inadequate for the individual participant, whatever applicable.
• Participants must have an average pain intensity score (NRS 3) greater than 5 points during the last 3 days prior to the Screening Visit. or
• If no regular analgesic pretreatment is reported:
• Participants must have an average pain intensity score (NRS-3) greater than 6 points in the last 3 days prior to the Screening Visit and related to low back pain.

You may not qualify if:

• 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:
• Participants with acute or severe bronchial asthma or hypercapnia.
• Participants 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.

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (46)

Site 5

Graz, Austria

Location

Site 1

Vienna, Austria

Location

Site 2

Vienna, Austria

Location

Site 3

Vienna, Austria

Location

Site 4

Vienna, Austria

Location

Site 3

Karlovac, Croatia

Location

Site 2

Opatija, Croatia

Location

Site 1

Sisak, Croatia

Location

Site 2

Châteaugiron, France

Location

Site 4

La Seyne-sur-Mer, France

Location

Site 3

Murs Erigné, France

Location

Site 1

Paris, France

Location

Site 3

Berlin, Germany

Location

Site 7

Böblingen, Germany

Location

Site 4

Celle, Germany

Location

Site 1

Dresden, Germany

Location

Site 6

Hanover, Germany

Location

Site 8

Leipzig, Germany

Location

Site 5

Lünen, Germany

Location

Site 2

Wiesbaden, Germany

Location

Site 6

Bologna, Italy

Location

Site 5

Catania, Italy

Location

Site 2

Genova, Italy

Location

Site 4

Parma, Italy

Location

Site 3

Pavia, Italy

Location

Site 1

Rome, Italy

Location

Site 1

Lublin, Poland

Location

Site 4

Tychy, Poland

Location

Site 3

Wroclaw, Poland

Location

Site 5

Alicante, Spain

Location

Site 1

Badalona, Spain

Location

Site 7

Guadalajara, Spain

Location

Site 6

Madrid, Spain

Location

Site 4

Oviedo, Spain

Location

Site 8

Pamplona, Spain

Location

Site 3

Valencia, Spain

Location

Site 1

Morges, Switzerland

Location

Site 2

Valens, Switzerland

Location

Site 7

Belfast, United Kingdom

Location

Site 2

Bristol, United Kingdom

Location

Site 8

Chelmsford, United Kingdom

Location

Site 6

Edinburgh, United Kingdom

Location

Site 1

Glasgow, United Kingdom

Location

Site 4

London, United Kingdom

Location

Site 5

London, United Kingdom

Location

Site 3

Plymouth, United Kingdom

Location

Related Publications (1)

• Steigerwald I, Muller M, Davies A, Samper D, Sabatowski R, Baron R, Rozenberg S, Szczepanska-Szerej A, Gatti A, Kress HG. Effectiveness and safety of tapentadol prolonged release for severe, chronic low back pain with or without a neuropathic pain component: results of an open-label, phase 3b study. Curr Med Res Opin. 2012 Jun;28(6):911-36. doi: 10.1185/03007995.2012.679254. Epub 2012 May 9.

  PMID: 22443293 RESULT

MeSH Terms

Conditions

Chronic Pain; Low Back Pain; Pain

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Grünenthal GmbH

Clinical-Trials@grunenthal.com

+49 241 569

Study Officials

• Hans Kress, Prof. MD

  Medical University / AKH Vienna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 24, 2009
• Study Start: September 30, 2009
• Primary Completion: May 1, 2010
• Study Completion: July 6, 2010
• Last Updated: January 15, 2019
• Results First Posted: April 17, 2012

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

AU (5); IT (6); CH (2); CR (3); ES (7); GB (8); DE (8); FR (4); PL (3)