Tapentadol (CG5503)

NCT00421928 | Completed Phase 3 Results

• 3 other identifiers: CR013402R331333PAI3008KF11
• Study Type: interventional
• Target: 1,030
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250 mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the knee, in comparison with placebo and Oxycodone Controlled Release (CR).

Conditions

Osteoarthritis, Knee; Pain

Keywords

Chronic Pain; Osteoarthritis, Knee; tapentadol; Pain Assessment

Outcome Measures

Primary Outcomes (1)

• Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.

  For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours 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".

  Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).

Secondary Outcomes (6)

• Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12

  Baseline and 12 week endpoint

• Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.

  Baseline and 12 week endpoint

• Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12

  Baseline and 12 week endpoint

• Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy

  Baseline to 12 weeks

• Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12

  Baseline and 12 week endpoint

Study Arms (3)

001

EXPERIMENTAL

tapentadol (CG5503) 50 100 150 200 250mg twice a day (BID) during 15 weeks

Drug: tapentadol (CG5503)

002

ACTIVE COMPARATOR

oxycodone 10 20 30 40 50mg twice a day (BID) during 15 weeks

Drug: oxycodone

003

PLACEBO COMPARATOR

placebo matching placebo twice a day (BID) during 15 weeks

Drug: placebo

Interventions

oxycodone DRUG

10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks

002

placebo DRUG

matching placebo twice a day (BID) during 15 weeks

003

tapentadol (CG5503) DRUG

50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks

001

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with osteoarthritis of the knee based on the American College of Rheumatology (ACR) criteria and functional capacity class of I-III
• patients taking analgesic medications for at least 3 months prior to screening and/or dissatisfied with their current therapy
• Patients requiring opioid treatment must be taking daily doses of opioid-based analgesic, equivalent to \<160 mg of oral morphine
• baseline score of greater than or equal to 5 on an 11-point numerical rating scale, calculated as the average pain intensity during the last 3 days prior to randomization.

You may not qualify if:

• History of alcohol and/or drug abuse in Investigator's judgement
• history of significant liver insufficiency
• chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past 3 months
• life-long history of seizure disorder or epilepsy
• history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated
• uncontrolled hypertension
• patients with severely impaired renal function
• patients with moderate to severly impaired hepatic function or with laboratory values reflecting inadequate hepatic function

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Grünenthal GmbH: collaborator

Related Publications (5)

• Etropolski M, Kuperwasser B, Flugel M, Haufel T, Lange B, Rauschkolb C, Laschewski F. Safety and tolerability of tapentadol extended release in moderate to severe chronic osteoarthritis or low back pain management: pooled analysis of randomized controlled trials. Adv Ther. 2014 Jun;31(6):604-20. doi: 10.1007/s12325-014-0128-6. Epub 2014 Jul 2.

  PMID: 24985410 DERIVED

• Biondi DM, Xiang J, Etropolski M, Moskovitz B. Evaluation of blood pressure and heart rate in patients with hypertension who received tapentadol extended release for chronic pain: a post hoc, pooled data analysis. Clin Drug Investig. 2014 Aug;34(8):565-76. doi: 10.1007/s40261-014-0209-y.

  PMID: 24916058 DERIVED

• Etropolski M, Lange B, Goldberg J, Steup A, Rauschkolb C. A pooled analysis of patient-specific factors and efficacy and tolerability of tapentadol extended release treatment for moderate to severe chronic pain. J Opioid Manag. 2013 Sep-Oct;9(5):343-56. doi: 10.5055/jom.2013.0177.

  PMID: 24353047 DERIVED

• Merchant S, Provenzano D, Mody S, Ho KF, Etropolski M. Composite measure to assess efficacy/gastrointestinal tolerability of tapentadol ER versus oxycodone CR for chronic pain: pooled analysis of randomized studies. J Opioid Manag. 2013 Jan-Feb;9(1):51-61. doi: 10.5055/jom.2013.0147.

  PMID: 23709304 DERIVED

• Afilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician. 2013 Jan;16(1):27-40.

  PMID: 23340531 DERIVED

Related Links

• A Randomized Double-Blind, Placebo \& Active-Control, Parallel-Arm Phase 3 Study With Controlled Dose Adjustment to Evaluate the Efficacy and Safety of Tapentadol Extended-Release (ER) in Subjects With Moderate to Severe Chronic Pain Due to OA of the Knee

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Chronic Pain

Interventions

Oxycodone; Tapentadol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Senior Director, Clinical Leader
• Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

609-730-4537

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 12, 2007
• First Posted: January 15, 2007
• Study Start: January 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 18, 2012
• Results First Posted: April 23, 2010

Record last verified: 2012-04