A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety
Public ClinicalTrials.gov record NCT00364533. 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
A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after patients completed the double blind period.
Study identification
- NCT ID
- NCT00364533
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 367 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- 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
- Sep 30, 2006
- Primary completion
- Nov 30, 2007
- Completion
- Nov 30, 2007
- Last update posted
- Apr 20, 2014
2006 – 2007
United States locations
- U.S. sites
- 45
- U.S. states
- 22
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Mobile | Alabama | — | — |
| Not listed | Sheffield | Alabama | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Fort Smith | Arkansas | — | — |
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Anaheim | California | — | — |
| Not listed | Arcadia | California | — | — |
| Not listed | Glendale | California | — | — |
| Not listed | Laguna Hills | California | — | — |
| Not listed | Sacramento | California | — | — |
| Not listed | San Francisco | California | — | — |
| Not listed | Denver | Colorado | — | — |
| Not listed | Farmington | Connecticut | — | — |
| Not listed | Boynton Beach | Florida | — | — |
| Not listed | DeLand | Florida | — | — |
| Not listed | Fort Lauderdale | Florida | — | — |
| Not listed | Hollywood | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Plantation | Florida | — | — |
| Not listed | Port Orange | Florida | — | — |
| Not listed | Tamarac | Florida | — | — |
| Not listed | Decatur | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Peoria | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Topeka | Kansas | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Royal Oak | Michigan | — | — |
| Not listed | Albany | New York | — | — |
| Not listed | Mineola | New York | — | — |
| Not listed | Charlotte | North Carolina | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Sewickley | Pennsylvania | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Grapevine | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Lubbock | Texas | — | — |
| Not listed | Plano | Texas | — | — |
| Not listed | Murray | Utah | — | — |
| Not listed | Weston | 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 32 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00364533, 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 Apr 20, 2014 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00364533 live on ClinicalTrials.gov.