An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain
Public ClinicalTrials.gov record NCT00487435. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00487435
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,166 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2007 (Type not available)
- Primary completion
- Jun 2009 (Actual)
- Completion
- Jun 2009 (Actual)
- Last update posted
- May 9, 2014
2007 – 2009
United States locations
- U.S. sites
- 118
- U.S. states
- 36
- U.S. cities
- 118
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Hoover | Alabama | — | — |
| Not listed | Mobile | Alabama | — | — |
| Not listed | Mesa | Arizona | — | — |
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| Not listed | Fresno | California | — | — |
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| Not listed | Chiefland | Florida | — | — |
| Not listed | Clearwater | Florida | — | — |
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| Not listed | New Port Richey | Florida | — | — |
| Not listed | Oldsmar | Florida | — | — |
| Not listed | Pembroke Pines | Florida | — | — |
| Not listed | Plantation | Florida | — | — |
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| Not listed | Sarasota | Florida | — | — |
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| Not listed | Tampa | Florida | — | — |
| Not listed | Athens | Georgia | — | — |
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| Not listed | Decatur | Georgia | — | — |
| Not listed | Marietta | Georgia | — | — |
| Not listed | Perry | Georgia | — | — |
| Not listed | Suwanee | Georgia | — | — |
| Not listed | Woodstock | Georgia | — | — |
| Not listed | Honolulu | Hawaii | — | — |
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| Not listed | Valparaiso | Indiana | — | — |
| Not listed | West Des Moines | Iowa | — | — |
| Not listed | Overland Park | Kansas | — | — |
| Not listed | Prairie Village | Kansas | — | — |
| Not listed | Topeka | Kansas | — | — |
| Not listed | Madisonville | Kentucky | — | — |
| Not listed | Baton Rouge | Louisiana | — | — |
| Not listed | Lake Charles | Louisiana | — | — |
| Not listed | Mandeville | Louisiana | — | — |
| Not listed | Metairie | Louisiana | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Columbia | Maryland | — | — |
| Not listed | Owings Mills | Maryland | — | — |
| Not listed | Rockville | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Brighton | Massachusetts | — | — |
| Not listed | Fall River | Massachusetts | — | — |
| Not listed | North Dartmouth | Massachusetts | — | — |
| Not listed | Wellesley Hills | Massachusetts | — | — |
| Not listed | West Yarmouth | Massachusetts | — | — |
| Not listed | East Lansing | Michigan | — | — |
| Not listed | Grand Blanc | Michigan | — | — |
| Not listed | Kalamazoo | Michigan | — | — |
| Not listed | Troy | Michigan | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Omaha | Nebraska | — | — |
| Not listed | Cherry Hill | New Jersey | — | — |
| Not listed | Albuquerque | New Mexico | — | — |
| Not listed | Mamaroneck | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Williamsville | New York | — | — |
| Not listed | Greensboro | North Carolina | — | — |
| Not listed | Raleigh | North Carolina | — | — |
| Not listed | Winston-Salem | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Kettering | Ohio | — | — |
| Not listed | Toledo | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Medford | Oregon | — | — |
| Not listed | Allentown | Pennsylvania | — | — |
| Not listed | Chester | Pennsylvania | — | — |
| Not listed | Duncansville | Pennsylvania | — | — |
| Not listed | Morrisville | Pennsylvania | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Greenville | South Carolina | — | — |
| Not listed | Prosperity | South Carolina | — | — |
| Not listed | Sioux Falls | South Dakota | — | — |
| Not listed | Clarksville | Tennessee | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Amarillo | Texas | — | — |
| Not listed | Austin | Texas | — | — |
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| Not listed | Hurst | Texas | — | — |
| Not listed | Lubbock | Texas | — | — |
| Not listed | Odessa | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Danville | Virginia | — | — |
| Not listed | Roanoke | Virginia | — | — |
| Not listed | Virginia Beach | Virginia | — | — |
| Not listed | Bellevue | Washington | — | — |
| Not listed | Tacoma | Washington | — | — |
| Not listed | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00487435, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 9, 2014 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00487435 live on ClinicalTrials.gov.