Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic

NCT00983073 | Completed Phase 3 Results

• 2 other identifiers: 4411722009-010423-58
• Study Type: interventional
• Target: 224
• Locations: 5 countries
• Sites: 24

Brief Summary

The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain due to osteoarthritis of the knee 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; Osteoarthritis

Keywords

Osteoarthritis; Pain; Assessment; Tapentadol; Centrally acting analgesic; Chronic pain due to osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint is Defined as the Change From Week -1 of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6.

  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 value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity.

  Baseline to end of week 6

Secondary Outcomes (17)

• Average Pain Intensity Before the Start of Tapentadol Treatment

  Baseline

• Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment

  Baseline; End of Week 6 (6 Weeks)

• Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment

  Baseline; End of Week 12 (12 Weeks)

• EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time

  Baseline; End of Week 6 (6 Weeks)

• EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time

  Baseline; End of Week 12 (12 Weeks)

Study Arms (1)

Tapentadol

EXPERIMENTAL

Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol 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

Interventions

Tapentadol DRUG

Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg Tapentadol PR twice daily, adjusting at 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 500 mg of Tapentadol per day. Maintenance Period: Participants continuing on the dose established in the previous period.

Also known as: Nucynta, Palexia

Tapentadol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants have signed an Informed Consent Form indicating that they understand the purpose of and the 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 40 years of age.
• Participants must have a diagnosis of osteoarthritis of the knee based on the American College of Rheumatology (ACR) classification criteria:
• Knee pain and
• Radiographic osteophytes or
• Knee pain and
• Aged 40 years or above, and
• Morning stiffness of less than 30 minutes of duration and
• Crepitus on motion.
• Participants must have pain at the reference joint which has been present for at least 3 months.
• Participant'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 participant satisfaction with treatment scale (5-point VRS).
• If under regular, daily pretreatment:

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 thereof in the Investigator's judgment.
• 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 (24)

Site 1

Belfort, France

Location

Site 4

Marseille, France

Location

Site 2

Murs Erigné, France

Location

Site 3

Nantes, France

Location

Site 5

Berlin, Germany

Location

Site 2

Köln Dünnwald, Germany

Location

Site 4

Leipzig, Germany

Location

Site 6

Leipzig, Germany

Location

Site 1

Marl, Germany

Location

Site 3

Meine, Germany

Location

Site 8

Rudolstadt, Germany

Location

Site 4

Lodz, Poland

Location

Site 2

Warsaw, Poland

Location

Site 2

A Coruña, Spain

Location

Site 7

A Coruña, Spain

Location

Site 6

Lugo, Spain

Location

Site 3

Madrid, Spain

Location

Site 1

Torrelavega, Spain

Location

Site 3

London, United Kingdom

Location

Site 9

London, United Kingdom

Location

Site 06

Manchester, United Kingdom

Location

Site 08

Portsmouth, United Kingdom

Location

Site 1

Solihull, United Kingdom

Location

Site 4

Swansea, United Kingdom

Location

Related Publications (1)

• Steigerwald I, Muller M, Kujawa J, Balblanc JC, Calvo-Alen J. Effectiveness and safety of tapentadol prolonged release with tapentadol immediate release on-demand for the management of severe, chronic osteoarthritis-related knee pain: results of an open-label, phase 3b study. J Pain Res. 2012;5:121-38. doi: 10.2147/JPR.S30540. Epub 2012 Jun 15.

  PMID: 22792000 RESULT

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis; Pain

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Trial Helpdesk
• Organization: Grünenthal GmbH

clinical-trials@grunenthal.com

+49 241 569

Study Officials

• Jaime Calvo, Dr. MD

  Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria Santander, Spain

  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 21, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 21, 2019
• Results First Posted: March 29, 2012

Record last verified: 2019-10

Locations

DE (7); ES (5); FR (4); GB (6); PL (2)