A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain - Full Text View

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:	Grünenthal GmbH
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00361504

Purpose

The purpose of this study is to evaluate the safety profile of tapentadol (CG5503) PR at doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients with at least a 3-month history of low back pain, or pain caused by knee or hip osteoarthritis.

Condition	Intervention	Phase
Osteoarthritis, Hip Osteoarthritis, Knee Lower Back Pain Pain	Drug: tapentadol (CG5503) PR Drug: oxycodone CR	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	A One-Year, Randomized, Open-Label, Parallel-Arm, Phase 3 Long-Term Safety Trial, With Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR and Oxycodone CR in Subjects With Chronic Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Osteoarthritis

Drug Information available for: Oxycodone Tapentadol Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Number of Subjects With Treatment-emergent Adverse Events (TEAE) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS) [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Enrollment:	1122
Study Start Date:	October 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
001: Experimental	Drug: tapentadol (CG5503) PR then 100mg twice/day x 4 days Drug: tapentadol (CG5503) PR 50mg twice/day x 3 days
002: Active Comparator	Drug: oxycodone CR maximum dose 250 mg twice/day Drug: oxycodone CR During Maintenance phase 100mg twice/day

Detailed Description:

Tapentadol (CG5503) is a centrally active pain-relieving drug being investigated for the treatment of acute and chronic pain. This study is a randomized (patients are assigned different treatments based on chance in a ratio of 4 patients on tapentadol (CG5503) PR to every 1 patient on oxycodone CR), open-label (both the Investigator and the patient know what medication is allocated), active-controlled, parallel-group, multicenter study. It is designed to investigate the long-term safety (side effects during up to one year of administration) and effectiveness (level of pain control) of tapentadol (CG5503) PR compared to oxycodone CR (an opioid commonly used for relief of moderate to severe pain) taken orally. The doses of both of these medications will be adjusted to give the best therapeutic benefit for the patient. Approximately 1075 patients will be screened. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Assessments of pain relief include the pain intensity numerical rating scale, and patient global impression of change scale (PGIC). Venous blood samples will be collected for the determination of serum concentrations of tapentadol (CG5503) and oxycodone. Tapentadol (CG5503) PR is also referred to as Tapentadol (CG5503) Extended Release (ER). Starting oral dose is randomly assigned to tapentadol (CG5503) PR 50 mg or oxycodone CR 10 mg twice daily (BID) x 3days; then increase to tapentadol (CG5503)100 mg BID, oxycodone CR 20 mg BID x 4 days; during the maintenance phase upward titration may occur at a minimum of 3 day intervals in increments of tapentadol (CG5503) PR 50 mg BID or oxycodone CR 10 mg BID. The maximum doses are tapentadol (CG5503) PR 250 mg BID or oxycodone CR 50 mg BID

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference joint for at least 3 months or clinical diagnosis of low back pain of benign origin for at least 3 months
Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen
Have a pain intensity >4 on Numerical Rating Scale

Exclusion Criteria:

Life-long history of seizure disorder or epilepsy
Any of the following within one year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, and brain neoplasm
Severe traumatic brain injury within 15 years (consisting of more than one of the following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma, unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness
History of malignancy within past 2 years, with exception of a successfully treated basal cell carcinoma
Presence of significant pain associated with conditions other than osteoarthritis or low back pain that could confound the assessment or self-evaluation of pain

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361504

Sponsors and Collaborators

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

Grünenthal GmbH

Investigators

Study Director:

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

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

More Information

No publications provided

Responsible Party:	Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Senior Director, Clinical Leader )
Study ID Numbers:	CR011074
Study First Received:	August 4, 2006
Results First Received:	July 24, 2009
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00361504 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Osteoarthritis
Pain
Low Back Pain
Hip Pain

Knee Pain
Backache
Tapentadol

Additional relevant MeSH terms:

Osteoarthritis
Joint Diseases
Physiological Effects of Drugs
Oxycodone
Nervous System Diseases
Central Nervous System Depressants
Low Back Pain
Narcotics
Pain
Osteoarthritis, Hip
Rheumatic Diseases
Back Pain

Pharmacologic Actions
Osteoarthritis, Knee
Signs and Symptoms
Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Arthritis
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010