ClinicalTrials.gov record
Long Term Safety and Tolerability Study in Approximately 350 Subjects With Moderate to Severe Chronic, Non-malignant Pain
ClinicalTrials.gov ID: NCT00195728
Public ClinicalTrials.gov record NCT00195728. 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
An Open-Label Study Evaluating the Safety and Tolerability of Long Term Administration of Hydrocodone/Acetaminophen Extended ReleaseTablets (Vicodin® CR) in Subjects With Moderate to Severe Chronic, Non-Malignant Pain
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to evaluate the safety of Vicodin CR (combination opioid and acetaminophen containing product) in patients with chronic pain due to osteoarthritis or low back pain.
Study identification
- NCT ID
- NCT00195728
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 431 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 21 Years to 75 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
- Jun 2005 (Type not available)
- Primary completion
- Dec 2006 (Actual)
- Completion
- Dec 2006 (Actual)
- Last update posted
- Jan 19, 2011
2005 – 2006
United States locations
- U.S. sites
- 76
- U.S. states
- 26
- U.S. cities
- 63
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site Ref # / Investigator 1696 | Huntsville | Alabama | 35801 | — |
| Site Reference # / Investigator 1729 | Chandler | Arizona | 85224 | — |
| Site Reference # / Investigator 1702 | Mesa | Arizona | 85210 | — |
| Site Reference # / Investigator 1745 | Peoria | Arizona | 85381 | — |
| Site Ref # / Investigator 1697 | Tempe | Arizona | 85282 | — |
| Site Ref # / Investigator 1818 | Tempe | Arizona | 85282 | — |
| Site Reference # / Investigator 1795 | Tucson | Arizona | 85741 | — |
| Site Ref # / Investigator 2555 | Carmichael | California | 95608 | — |
| Site Reference # / Investigator 1688 | Fair Oaks | California | 95628 | — |
| Site Reference # / Investigator 1790 | Pasadena | California | 21122 | — |
| Site Reference # / Investigator 1735 | San Diego | California | 92108 | — |
| Site Reference # / Investigator 1775 | San Luis Obispo | California | 93401 | — |
| Site Ref # / Investigator 1742 | Santa Ana | California | 92705 | — |
| Site Ref # / Investigator 1754 | Tarzana | California | 91356 | — |
| Site Reference # / Investigator 1700 | Whittier | California | 90601 | — |
| Site Reference # / Investigator 1690 | Colorado Springs | Colorado | 80904 | — |
| Site Ref # / Investigator 1713 | Littleton | Colorado | 80120 | — |
| Site Ref # / Investigator 1711 | Bristol | Connecticut | 06010 | — |
| Site Reference # / Investigator 1723 | Clearwater | Florida | 33756 | — |
| Site Ref # / Investigator 1813 | Clearwater | Florida | 33761 | — |
| Site Reference # / Investigator 1718 | DeLand | Florida | 32720 | — |
| Site Reference # / Investigator 1819 | Longwood | Florida | 32779 | — |
| Site Reference # / Investigator 1809 | Miami | Florida | 33156 | — |
| Site Reference # / Investigator 1738 | Miami | Florida | 33173 | — |
| Site Ref # / Investigator 1716 | Orlando | Florida | 32806 | — |
| Site Reference # / Investigator 1755 | Palm Harbor | Florida | 34684 | — |
| Site Ref # / Investigator 1814 | Pembroke Pines | Florida | 33024 | — |
| Site Reference # / Investigator 1737 | Plantation | Florida | 33324 | — |
| Site Reference # / Investigator 1747 | St. Petersburg | Florida | 33702 | — |
| Site Reference # / Investigator 1744 | Arlington Heights | Illinois | 60005 | — |
| Site Reference # / Investigator 1691 | Chicago | Illinois | 60612 | — |
| Site Reference # / Investigator 1714 | Evansville | Indiana | 47714 | — |
| Site Ref # / Investigator 1739 | Metairie | Louisiana | 70006 | — |
| Site Reference # / Investigator 1810 | Owings Mills | Maryland | 21117 | — |
| Site Ref # / Investigator 1707 | Fall River | Massachusetts | 02720 | — |
| Site Reference # / Investigator 1743 | Wellesley Hills | Massachusetts | 02481-2106 | — |
| Site Ref # / Investigator 1792 | Jackson | Mississippi | 39202 | — |
| Site Reference # / Investigator 1721 | St Louis | Missouri | 63117 | — |
| Site Ref # / Investigator 1812 | St Louis | Missouri | 63141 | — |
| Site Reference # / Investigator 2424 | St Louis | Missouri | 63141 | — |
| Site Ref # / Investigator 1722 | Omaha | Nebraska | 68134 | — |
| Site Ref # / Investigator 1774 | Omaha | Nebraska | 68134 | — |
| Site Reference # / Investigator 1789 | Omaha | Nebraska | 68134 | — |
| Site Reference # / Investigator 1705 | Las Vegas | Nevada | 89104 | — |
| Site Reference # / Investigator 1791 | Las Vegas | Nevada | 89123 | — |
| Site Reference # / Investigator 1701 | Medford | New Jersey | 08055 | — |
| Site Reference # / Investigator 2461 | Trenton | New Jersey | 08629-1986 | — |
| Site Reference # / Investigator 1726 | Binghamton | New York | 13901 | — |
| Site Reference # / Investigator 1815 | New York | New York | 10022 | — |
| Site Reference # / Investigator 1708 | Charlotte | North Carolina | 28210 | — |
| Site Ref # / Investigator 1730 | Monroe | North Carolina | 28112 | — |
| Site Reference # / Investigator 1741 | Raleigh | North Carolina | 27609 | — |
| Site Reference # / Investigator 1689 | Cincinnati | Ohio | 45227 | — |
| Site Ref # / Investigator 1694 | Cincinnati | Ohio | 45236 | — |
| Site Ref # / Investigator 1816 | Cleveland | Ohio | 44122 | — |
| Site Reference # / Investigator 1715 | Oklahoma City | Oklahoma | 73103 | — |
| Site Reference # / Investigator 2423 | Portland | Oregon | 97239 | — |
| Site Reference # / Investigator 1794 | Beaver | Pennsylvania | 15009 | — |
| Site Reference # / Investigator 1749 | Duncansville | Pennsylvania | 16635 | — |
| Site Reference # / Investigator 1752 | Erie | Pennsylvania | 16508-1256 | — |
| Site Reference # / Investigator 1709 | Mechanicsburg | Pennsylvania | 17055 | — |
| Site Reference # / Investigator 1757 | Cordova | Tennessee | 38018 | — |
| Site Reference # / Investigator 1727 | Selmer | Tennessee | 38375 | — |
| Site Ref # / Investigator 1692 | Austin | Texas | 78705 | — |
| Site Reference # / Investigator 1722 | Austin | Texas | 78728 | — |
| Site Reference # / Investigator 2425 | Dallas | Texas | 75235 | — |
| Site Reference # / Investigator 1699 | Fort Worth | Texas | 76135 | — |
| Site Ref # / Investigator 1725 | Killeen | Texas | 76543 | — |
| Site Reference # / Investigator 1710 | San Angelo | Texas | 76904 | — |
| Site Reference # / Investigator 1686 | San Antonio | Texas | 78209 | — |
| Site Reference # / Investigator 2426 | San Antonio | Texas | 78217 | — |
| Site Reference # / Investigator 1808 | San Antonio | Texas | 78229 | — |
| Site Reference # / Investigator 1732 | Salt Lake City | Utah | 84102 | — |
| Site Reference # / Investigator 1740 | Salt Lake City | Utah | 84109 | — |
| Site Ref # / Investigator 1733 | Norfolk | Virginia | 23502-9921 | — |
| Site Reference # / Investigator 1719 | Virginia Beach | Virginia | 23455 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00195728, 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 Jan 19, 2011 · Synced Oct 26, 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 NCT00195728 live on ClinicalTrials.gov.