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Osteoarthritis, HipPhase 3NCT00361504

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

A Phase 3 study testing Oxycodone CR and Tapentadol (CG5503) ER in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 52 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oxycodone CR and Tapentadol (CG5503) ER
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,123 participants
Where
52 sitesin 2 countries
Study dates
Nov 2006to Jul 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

United States40 sites

  • Study site

    Anaheim, California

  • Study site

    Atlanta, Georgia

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Chiefland, Florida

  • Study site

    Clearwater, Florida

  • Study site

    Cudahy, California

  • Study site

    Cumming, Georgia

  • Study site

    Decatur, Georgia

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Encinitas, California

  • Study site

    Greenville, South Carolina

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kettering, Ohio

  • Study site

    Las Vegas, Nevada

  • Study site

    Mamaroneck, New York

  • Study site

    Medford, Oregon

  • Study site

    Mesa, Arizona

  • Study site

    Oldsmar, Florida

  • Study site

    Paducah, Kentucky

  • Study site

    Perry, Georgia

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Prairie Village, Kansas

  • Study site

    Raleigh, North Carolina

  • Study site

    Roanoke, Virginia

  • Study site

    Rockville, Maryland

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Suwanee, Georgia

  • Study site

    Topeka, Kansas

  • Study site

    Trumbull, Connecticut

  • Study site

    Tucson, Arizona

  • Study site

    Wellesley Hills, Massachusetts

  • Study site

    Westlake Village, California

  • Study site

    Williamsville, New York

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Woodstock, Georgia

Other trials in United States

Canada12 sites

  • Study site

    Coquitlam, British Columbia

  • Study site

    Corunna, Ontario

  • Study site

    Edmonton, Alberta

  • Study site

    Greater Sudbury, Ontario

  • Study site

    Halifax, Nova Scotia

  • Study site

    Mississauga, Ontario

  • Study site

    Pointe-Claire, Quebec

  • Study site

    Sarnia, Ontario

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    Toronto, Ontario

  • Study site

    Trois-Rivières, Quebec

  • Study site

    Vancouver, Ontario

Other trials in Canada

About this 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

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.

Read the 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 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.

Being tested
Oxycodone CR, Tapentadol (CG5503) ER
Keywords
Osteoarthritis, Pain, Low Back Pain, Hip Pain, Knee Pain, Backache, Tapentadol
Medical subject headings
Osteoarthritis, Hip, Osteoarthritis, Knee, Low Back Pain, Pain, Osteoarthritis, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxycodone CRDrug

    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.

  • Tapentadol (CG5503) ERDrug

    Also called CG5503

    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.

Study groups in NCT00361504
Study groupRoleWhat they receive
Tapentadol (CG5503)ExperimentalTapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year.
Receives: Drug: Tapentadol (CG5503) ER
OxycodoneActive comparatorOxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.
Receives: Drug: Oxycodone CR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-emergent Adverse Events (TEAE)

    The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication.

    Measured: 52 weeks

Secondary outcomes (1)

  1. Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)

    The Participants indicated the average level of pain experienced, at each study visit, over the previous 24 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 was the average pain intensity scores measured prior to randomization (At Week 1). At Week 52 again the average pain intensity scores were collected and the change in scores at Week 52 from the baseline scores was considered as the change from baseline in average pain intensity scores at Week 52.

    Measured: Baseline, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00361504
Sponsor's protocol ID
CR011074
Other IDs
R331333PAI3007
Status last verified
Apr 2014
First submitted
4 Aug 2006
Last updated
29 Apr 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 24985410

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

    PubMed 23340531

  • 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.

    PubMed 20602712

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxycodone CR and Tapentadol (CG5503) ER in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 52 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events (TEAE) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00361504, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.

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