Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking WHO Step III Analgesics But Showing a Lack of Tolerability.

NCT00982280 | Terminated Phase 3 Results

• 2 other identifiers: 8470222009-010425-39
• Study Type: interventional
• Target: 82
• Locations: 6 countries
• Sites: 24

Brief Summary

The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release (PR) in participants suffering from severe chronic pain due to osteoarthritis of the knee 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 subject-reported outcome. 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.

Conditions

Chronic Pain; Osteoarthritis

Keywords

Osteoarthritis; pain assessment; tapentadol; centrally acting analgesic

Outcome Measures

Primary Outcomes (1)

• Responder Rate

  Participants were considered responders if they reported the same or less average pain intensity over a 3 day period after 6 weeks of tapentadol PR treatment as with their previous analgesic treatment.

  6 weeks

Secondary Outcomes (19)

• Average Pain Intensity Before the Start of Tapentadol Treatment

  Baseline

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

  Baseline; Week 6 (6 weeks)

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

  Baseline; Week 12 (12 weeks)

• Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee

  Baseline

• Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 6

  6 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 PR

Interventions

Tapentadol PR DRUG

Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg, 100 mg or 150 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 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 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
• Participant must be taking a WHO Step III analgesic on a daily basis for at least 2 weeks prior to the Screening Visit.
• Participant must have responded to the WHO Step III analgesic, i.e., participant must have a confirmed average pain intensity score (NRS 3) of smaller or equal to 5 points during the last 3 days prior to the Screening Visit.
• Participant must report opioid-related side effects as the reason to change their analgesic

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 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 (24)

Site 4

Melbourne, Australia

Location

Site 2

Perth, Australia

Location

Site 4

Aalborg, Denmark

Location

Site 7

Hvidovre, Denmark

Location

Site 6

Kolding, Denmark

Location

Site 2

Odense, Denmark

Location

Site 3

Vejle, Denmark

Location

Site 1

Berlin, Germany

Location

Site 7

Katzhütte, Germany

Location

Site 2

Leer, Germany

Location

Site 8

Leipzig, Germany

Location

Site 9

Zerbst, Germany

Location

Site 4

Lublin, Poland

Location

Site 5

Ostrów Mazowiecka, Poland

Location

Site 2

Tychy, Poland

Location

Site 4

Madrid, Spain

Location

Site 1

Valencia, Spain

Location

Site 3

Birmingham, United Kingdom

Location

Site 6

Carmarthen, United Kingdom

Location

Site 1

Leeds, United Kingdom

Location

Site 2

London, United Kingdom

Location

Site 8

Middlesbrough, United Kingdom

Location

Site 9

Oxford, United Kingdom

Location

Site 10

York, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis

Interventions

Tapentadol

Condition Hierarchy (Ancestors)

Pain; 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: Dr. Ilona Steigerwald
• Organization: Grünenthal GmbH

Clinical-Trials@grunenthal.com

+49 241 569 0

Study Officials

• Barbara Hoggart, Dr. MD

  FRCA, FRCAPM Heart of England NHS Trust

  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 22, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 18, 2019
• Results First Posted: December 14, 2011

Record last verified: 2019-10

Locations

AU (2); DE (5); PL (3); ES (2); DK (5); GB (7)