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PainPhase 3NCT00487435

An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain

A Phase 3 study testing Tapentadol (CG5503) Extended Release (ER) in people with Pain and Osteoarthritis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 148 sites in 4 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 the study is to assess the long-term safety profile of Tapentadol (CG5503) extended release (ER) at dosages ranging from 100 to 250 mg twice a day in treating patients with moderate to severe chronic pain over a period of 1 year. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Osteoarthritis, Low Back Pain
What is being tested?
Tapentadol (CG5503) Extended Release (ER)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,166 participants
Where
148 sitesin 4 countries
Study dates
Jun 2007to Jun 2009
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

  • Non-lactating female subjects (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. Female patients of childbearing potential must have a negative pregnancy test at screening.)
  • Completion of the expected double-blind treatment period of the pivotal Tapentadol (CG5503) Phase 3 trials in osteoarthritis (R331333-PAI-3008, KF5503/11) or low back pain (R331333-PAI-3011, KF5503/23), or completion of the 1-year treatment period of the safety CG5503 Phase 3 trial in the non-European sites (R331333-PAI-3007, KF5503/24)
  • Must be willing to take Tapentadol (CG5503) extended release (ER) and the rescue medication supplied for the duration of the trial

Who cannot join

  • History of alcohol and/or drug abuse, life-long history of seizure disorder or epilepsy, any of the following within the past year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm
  • Severe traumatic brain injury within the past 15 years
  • Uncontrolled hypertension (repeated systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg)
  • Severely impaired renal function
  • Moderately or severely impaired hepatic function
  • Patients taking neuroleptics, monoamine oxidase inhibitors, or tricyclic antidepressants within 14 days prior to screening.

Trial locations and contacts

148 sites in 4 countries.

148 sites in 4 countries

United States118 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Allentown, Pennsylvania

  • Study site

    Amarillo, Texas

  • Study site

    Anaheim, California

  • Study site

    Athens, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Avon, Indiana

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Bellevue, Washington

  • Study site

    Birmingham, Alabama

  • Study site

    Boise, Idaho

  • Study site

    Boston, Massachusetts

  • Study site

    Brighton, Massachusetts

  • Study site

    Carmichael, California

  • Study site

    Cherry Hill, New Jersey

  • Study site

    Chester, Pennsylvania

  • Study site

    Chicago, Illinois

  • Study site

    Chiefland, Florida

  • Study site

    Cincinnati, Ohio

  • Study site

    Clarksville, Tennessee

  • Study site

    Clearwater, Florida

  • Study site

    Columbia, Maryland

  • Study site

    Dallas, Texas

  • Study site

    Danville, Virginia

  • Study site

    Decatur, Georgia

  • Study site

    Duncansville, Pennsylvania

  • Study site

    East Lansing, Michigan

  • Study site

    Encinitas, California

  • Study site

    Evansville, Indiana

  • Study site

    Fall River, Massachusetts

  • Study site

    Fort Myers, Florida

  • Study site

    Fresno, California

  • Study site

    Grand Blanc, Michigan

  • Study site

    Greensboro, North Carolina

  • Study site

    Greenville, South Carolina

  • Study site

    Hallandale, Florida

  • Study site

    Hollywood, Florida

  • Study site

    Honolulu, Hawaii

  • Study site

    Hoover, Alabama

  • Study site

    Houston, Texas

  • Study site

    Huntington Park, California

  • Study site

    Hurst, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Jonesboro, Arkansas

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kettering, Ohio

  • Study site

    Kissimmee, Florida

  • Study site

    Laguna Hills, California

  • Study site

    Lake Charles, Louisiana

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Gatos, California

  • Study site

    Lubbock, Texas

  • Study site

    Madisonville, Kentucky

  • Study site

    Mamaroneck, New York

  • Study site

    Mandeville, Louisiana

  • Study site

    Marietta, Georgia

  • Study site

    Medford, Oregon

  • Study site

    Meridian, Idaho

  • Study site

    Mesa, Arizona

  • Study site

    Metairie, Louisiana

  • Study site

    Miami, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mobile, Alabama

  • Study site

    Morrisville, Pennsylvania

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Study site

    New Port Richey, Florida

  • Study site

    New York, New York

  • Study site

    North Dartmouth, Massachusetts

  • Study site

    Odessa, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Oldsmar, Florida

  • Study site

    Omaha, Nebraska

  • Study site

    Overland Park, Kansas

  • Study site

    Owings Mills, Maryland

  • Study site

    Pembroke Pines, Florida

  • Study site

    Perry, Georgia

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Pico Rivera, California

  • Study site

    Pismo Beach, California

  • Study site

    Plantation, Florida

  • Study site

    Port Orange, Florida

  • Study site

    Prairie Village, Kansas

  • Study site

    Prosperity, South Carolina

  • Study site

    Raleigh, North Carolina

  • Study site

    Roanoke, Virginia

  • Study site

    Rockville, Maryland

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Sarasota, Florida

  • Study site

    Sioux Falls, South Dakota

  • Study site

    St Louis, Missouri

  • Study site

    Stamford, Connecticut

  • Study site

    Suwanee, Georgia

  • Study site

    Tacoma, Washington

  • Study site

    Tamarac, Florida

  • Study site

    Tampa, Florida

  • Study site

    Tempe, Arizona

  • Study site

    Toledo, Ohio

  • Study site

    Topeka, Kansas

  • Study site

    Troy, Michigan

  • Study site

    Trumbull, Connecticut

  • Study site

    Tucson, Arizona

  • Study site

    Upland, California

  • Study site

    Valparaiso, Indiana

  • Study site

    Virginia Beach, Virginia

  • Study site

    Wellesley Hills, Massachusetts

  • Study site

    West Des Moines, Iowa

  • Study site

    West Yarmouth, 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

Canada23 sites

  • Study site

    Ajax, Ontario

  • Study site

    Brampton, Ontario

  • Study site

    Charlottetown, Prince Edward Island

  • Study site

    Chilliwack, British Columbia

  • Study site

    Greater Sudbury, Ontario

  • Study site

    Halifax

  • Study site

    Kelowna, British Columbia

  • Study site

    Kitchener, Ontario

  • Study site

    London, Ontario

  • Study site

    Markham, Ontario

  • Study site

    Mississauga, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Penticton, British Columbia

  • Study site

    Pointe-Claire, Quebec

  • Study site

    Saint Romuald, Quebec

  • Study site

    Sarnia, Ontario

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    Sherbrooke, Quebec

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Vancouver, Ontario

Other trials in Canada

Australia4 sites

  • Study site

    Adelaide

  • Study site

    Melbourne

  • Study site

    Newcastle

  • Study site

    Woodville North

Other trials in Australia

New Zealand3 sites

  • Study site

    Christchurch

  • Study site

    Tauranga

  • Study site

    Wellington

Other trials in New Zealand

About this study

Official title: Open-Label Extension, Single-Arm, Flexible-Dosing, Phase 3 Trial With CG5503 Extended-Release (ER) in Patients With Moderate to Severe Chronic Pain

The purpose of the study is to assess the long-term safety profile of Tapentadol (CG5503) extended release (ER) at dosages ranging from 100 to 250 mg twice a day in treating patients with moderate to severe chronic pain over a period of 1 year. The study will also assess dosage requirements over the long term; characterize adverse events and tolerability, sleep quality, and potential symptoms of withdrawal; characterize pain intensity scores and overall impression of change; and characterize patient-related health outcomes.

Read the detailed description

All patients who complete the Phase 3 pivotal trials in osteoarthritis (R331333-PAI-3008; KF5503/11) and low back pain (R331333-PAI-3011; KF5503/23) and the Phase 3 safety trial in the non-European sites (R331333-PAI-3007; KF5503/24) will be allowed to continue participation in the program by entering this trial. The trial will consist of three periods (screening, open-label treatment period, and follow-up). In the open-label treatment/maintenance period (1 year), those patients in the safety trial R331333-PAI-3007 (KF5503/24) taking open-label Tapentadol (CG5503) extended release (ER) will continue the dosage they were taking without undergoing titration. All other patients will be titrated to the minimum therapeutic dosage of Tapentadol (CG5503) extended release (ER) over 1 week. The lowest therapeutic dose allowed in the study is 100 mg twice daily, and the maximum upper dosage of Tapentadol (CG5503) extended release (ER) base is 250 mg twice daily. Downward titration (not below the minimum therapeutic dose of 100 mg twice daily) is permitted at any time using the same decrements without any time restriction. Dosages will be assessed at the scheduled (and unscheduled, if any) visits and adjustment under investigator supervision will be made as necessary. Dosage adjustments should be kept to a minimum. Intake of paracetamol/acetaminophen two 500 mg tablets daily is permitted during the titration week, and during the remainder of the open-label treatment/maintenance period up to a maximum of 7 consecutive days but no more than 14 out of 30 days. Following Week 4, all visits will be scheduled at 4-week intervals, through Week 52. The end-of-treatment visit at Week 52 will include both safety and efficacy assessments. Patients will return to the site for a follow-up visit approximately 4 days after their last dose of Tapentadol (CG5503) extended release (ER) for final safety evaluations and completion of the opioid withdrawal assessments (clinical opioid withdrawal scale, or COWS, and subjective opioid withdrawal scale, or SOWS). Patients experiencing withdrawal symptoms prior to the follow-up visit may telephone and request to be seen sooner. Additionally, the research staff at the site will telephone subjects approximately 10 to 14 days after the last dose of Tapentadol (CG5503) extended release (ER) to inquire if any adverse events have occurred since the previous visit. Tapentadol (CG5503) extended release (ER): 50, 100, 150, 200, and 250 mg orally, taken twice daily (morning and evening) for a maximum duration of 1 year.

Being tested
Tapentadol (CG5503) Extended Release (ER)
Keywords
CG5503, Tapentadol, chronic non-malignant pain, osteoarthritis, lower back pain, analgesic, opioid
Medical subject headings
Pain, Osteoarthritis, Low Back Pain

What participants receive

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

  • Tapentadol (CG5503) Extended Release (ER)Drug

    100, 150, 200, 250 mg oral tablet twice daily for 52 weeks

Study groups in NCT00487435
Study groupRoleWhat they receive
001ExperimentalTapentadol (CG5503) Extended Release (ER) 100 150 200 250 mg oral tablet twice daily for 52 weeks
Receives: Drug: Tapentadol (CG5503) Extended Release (ER)

What is being measured

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

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

    The number of subjects 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 subjects 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".

    Measured: Baseline, 52 weeks

Timeline

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

  1. First posted18 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionJun 2009
  4. Study completionJun 2009

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00487435
Sponsor's protocol ID
CR013567
Other IDs
R331333PAI3010, KF18
Status last verified
Apr 2014
First submitted
14 Jun 2007
Last updated
9 May 2014
Data monitoring committee
No

Publications

  • Buynak R, Rappaport SA, Rod K, Arsenault P, Heisig F, Rauschkolb C, Etropolski M. Long-term Safety and Efficacy of Tapentadol Extended Release Following up to 2 Years of Treatment in Patients With Moderate to Severe, Chronic Pain: Results of an Open-label Extension Trial. Clin Ther. 2015 Nov 1;37(11):2420-38. doi: 10.1016/j.clinthera.2015.08.014. Epub 2015 Oct 1.

    PubMed 26428249

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tapentadol (CG5503) Extended Release (ER) in people with Pain and Osteoarthritis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 148 sites in 4 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 6 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 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in United States, Canada, Australia, New Zealand. 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 23 Jul 2010). 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 Subjects 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 NCT00487435, which also lists 1 linked publication.

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 9 May 2014.

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