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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

NCT ID: NCT00361504

Last Updated: 2014-04-29

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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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 study consisted of a screening period (up to 14 days), a washout period (3 to 7 days), and an active treatment phase with titration and maintenance (total duration of 52 weeks). The doses of both of these medications will be adjusted to give the best therapeutic benefit for the patient. A total of 1123 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 3 days; 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.

Conditions

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Osteoarthritis, Hip Osteoarthritis, Knee Lower Back Pain Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tapentadol (CG5503)

Tapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year.

Group Type EXPERIMENTAL

Tapentadol (CG5503) ER

Intervention Type DRUG

Tapentadol (CG5503) ER 50 mg oral tablet BID administered for first 3 days, 100 mg oral tablet BID administered for next 4 days, 100 to 250 mg oral tablet BID administered for the next 51 weeks.

Oxycodone

Oxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.

Group Type ACTIVE_COMPARATOR

Oxycodone CR

Intervention Type DRUG

Oxycodone CR 10 mg oral tablet BID administered for first 3 days, 20 mg oral tablet BID administered for next 4 days, 20 to 50 mg oral tablet BID administered for the next 51 weeks.

Interventions

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Oxycodone CR

Oxycodone CR 10 mg oral tablet BID administered for first 3 days, 20 mg oral tablet BID administered for next 4 days, 20 to 50 mg oral tablet BID administered for the next 51 weeks.

Intervention Type DRUG

Tapentadol (CG5503) ER

Tapentadol (CG5503) ER 50 mg oral tablet BID administered for first 3 days, 100 mg oral tablet BID administered for next 4 days, 100 to 250 mg oral tablet BID administered for the next 51 weeks.

Intervention Type DRUG

Other Intervention Names

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CG5503

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grünenthal GmbH

INDUSTRY

Sponsor Role collaborator

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

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Mesa, Arizona, United States

Site Status

Tucson, Arizona, United States

Site Status

Anaheim, California, United States

Site Status

Cudahy, California, United States

Site Status

Encinitas, California, United States

Site Status

San Diego, California, United States

Site Status

Westlake Village, California, United States

Site Status

Trumbull, Connecticut, United States

Site Status

Chiefland, Florida, United States

Site Status

Clearwater, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Oldsmar, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Cumming, Georgia, United States

Site Status

Decatur, Georgia, United States

Site Status

Perry, Georgia, United States

Site Status

Suwanee, Georgia, United States

Site Status

Woodstock, Georgia, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Prairie Village, Kansas, United States

Site Status

Topeka, Kansas, United States

Site Status

Paducah, Kentucky, United States

Site Status

Baton Rouge, Louisiana, United States

Site Status

Rockville, Maryland, United States

Site Status

Wellesley Hills, Massachusetts, United States

Site Status

Kalamazoo, Michigan, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Mamaroneck, New York, United States

Site Status

Williamsville, New York, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Kettering, Ohio, United States

Site Status

Medford, Oregon, United States

Site Status

Duncansville, Pennsylvania, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Greenville, South Carolina, United States

Site Status

Houston, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Roanoke, Virginia, United States

Site Status

Edmonton, Alberta, Canada

Site Status

Coquitlam, British Columbia, Canada

Site Status

Halifax, Nova Scotia, Canada

Site Status

Corunna, Ontario, Canada

Site Status

Greater Sudbury, Ontario, Canada

Site Status

Mississauga, Ontario, Canada

Site Status

Sarnia, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Vancouver, Ontario, Canada

Site Status

Pointe-Claire, Quebec, Canada

Site Status

Trois-Rivières, Quebec, Canada

Site Status

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 24985410 (View on PubMed)

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

Reference Type DERIVED
PMID: 23340531 (View on PubMed)

Wild JE, Grond S, Kuperwasser B, Gilbert J, McCann B, Lange B, Steup A, Haufel T, Etropolski MS, Rauschkolb C, Lange R. Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain. Pain Pract. 2010 Sep-Oct;10(5):416-27. doi: 10.1111/j.1533-2500.2010.00397.x.

Reference Type DERIVED
PMID: 20602712 (View on PubMed)

Other Identifiers

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R331333PAI3007

Identifier Type: OTHER

Identifier Source: secondary_id

CR011074

Identifier Type: -

Identifier Source: org_study_id

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