Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain
Public ClinicalTrials.gov record NCT01709214. 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, Placebo- and Active Controlled Study to Evaluate the Safety and Efficacy of GRT6005 in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are eligible for the Double-blind Treatment Period will be randomized to one of following treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200, 300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or placebo.
Study identification
- NCT ID
- NCT01709214
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 619 participants
Conditions and interventions
Interventions
- Cebranopadol (GRT6005) Low-Dose Range Drug
- Cebranopadol (GRT6005) High-Dose Range Drug
- Placebo Drug
- Oxycodone CR Drug
Drug
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
- Dec 4, 2012 (Actual)
- Primary completion
- Apr 2014 (Actual)
- Completion
- Apr 4, 2014 (Actual)
- Last update posted
- Jul 15, 2021
2012 – 2014
United States locations
- U.S. sites
- 83
- U.S. states
- 26
- U.S. cities
- 77
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 051 | Birmingham | Alabama | 35209 | — |
| Site 022 | Birmingham | Alabama | 35216 | — |
| Site 031 | Huntsville | Alabama | 35801 | — |
| Site 005 | Phoenix | Arizona | 85018 | — |
| Site 018 | Phoenix | Arizona | 85023 | — |
| Site 070 | Phoenix | Arizona | 85027 | — |
| Site 028 | Tucson | Arizona | 85712 | — |
| Site 081 | Chino | California | 91710 | — |
| Site 030 | El Cajon | California | 92020 | — |
| Site 039 | Fair Oaks | California | 95628 | — |
| Site 061 | Fresno | California | 93726 | — |
| Site 084 | North Hollywood | California | 91606 | — |
| Site 080 | Roseville | California | 95661 | — |
| Site 004 | Sacramento | California | 95821 | — |
| Site 044 | San Diego | California | 92117 | — |
| Site 043 | Tustin | California | 92780 | — |
| Site 010 | Walnut Creek | California | 94598 | — |
| Site 027 | Westlake Village | California | 91361 | — |
| Site 011 | Bradenton | Florida | 34209 | — |
| Site 071 | Clearwater | Florida | 33761 | — |
| Site 090 | Edgewater | Florida | 32132 | — |
| Site 060 | Jacksonville | Florida | 32256 | — |
| Site 015 | Jupiter | Florida | 33458 | — |
| Site 013 | Miami | Florida | 33144 | — |
| Site 003 | New Port Richey | Florida | 34652 | — |
| Site 012 | Ocala | Florida | 34474 | — |
| Site 032 | Orlando | Florida | 32806 | — |
| Site 025 | Ormond Beach | Florida | 32174 | — |
| Site 058 | Pembroke Pines | Florida | 33028 | — |
| Site 091 | Pinellas Park | Florida | 33781 | — |
| Site 007 | Sarasota | Florida | 34238 | — |
| Site 052 | Marietta | Georgia | 30066 | — |
| Site 033 | Perry | Georgia | 31069 | — |
| Site 073 | Stockbridge | Georgia | 30281 | — |
| Site 086 | Chicago | Illinois | 60612 | — |
| Site 041 | Indianapolis | Indiana | 46260 | — |
| Site 085 | Valparaiso | Indiana | 46383 | — |
| Site 088 | Towson | Maryland | 21204 | — |
| Site 077 | Wheaton | Maryland | 20902 | — |
| Site 083 | New Bedford | Massachusetts | 02740 | — |
| Site 021 | North Dartmouth | Massachusetts | 02747 | — |
| Site 020 | Worcester | Massachusetts | 01605 | — |
| Site 016 | Bingham Farms | Michigan | 48025 | — |
| Site 042 | Traverse City | Michigan | 49684 | — |
| Site 023 | St Louis | Missouri | 63141 | — |
| Site 087 | Grand Island | Nebraska | 68803 | — |
| Site 074 | Omaha | Nebraska | 68144 | — |
| Site 024 | Las Vegas | Nevada | 89130 | — |
| Site 072 | Las Vegas | Nevada | 89144 | — |
| Site 009 | Albuquerque | New Mexico | 87102 | — |
| Site 068 | Albany | New York | 12208 | — |
| Site 017 | Hartsdale | New York | 10530 | — |
| Site 056 | Greensboro | North Carolina | 27410 | — |
| Site 006 | High Point | North Carolina | 27262 | — |
| Site 078 | Wilmington | North Carolina | 28401 | — |
| Site 079 | Cincinnati | Ohio | 45219 | — |
| Site 008 | Cincinnati | Ohio | 45242 | — |
| Site 069 | Cleveland | Ohio | 44122 | — |
| Site 001 | Columbus | Ohio | 43213 | — |
| Site 048 | Toledo | Ohio | 43623 | — |
| Site 075 | Oklahoma City | Oklahoma | 73103 | — |
| Site 029 | Bend | Oregon | 97701 | — |
| Site 067 | Medford | Oregon | 97504 | — |
| Site 035 | Portland | Oregon | 97239 | — |
| Site 045 | Altoona | Pennsylvania | 16602 | — |
| Site 002 | Duncansville | Pennsylvania | 16635 | — |
| Site 034 | Anderson | South Carolina | 29621 | — |
| Site 076 | Charleston | South Carolina | 29407 | — |
| Site 093 | Bristol | Tennessee | 37620 | — |
| Site 055 | Austin | Texas | 78731 | — |
| Site 049 | Bryan | Texas | 77802 | — |
| Site 038 | Dallas | Texas | 75203 | — |
| Site 089 | San Antonio | Texas | 78209 | — |
| Site 040 | San Antonio | Texas | 78229 | — |
| Site 082 | Wichita Falls | Texas | 76309 | — |
| Site 019 | Draper | Utah | 84020 | — |
| Site 064 | Ogden | Utah | 84405 | — |
| Site 059 | Salt Lake City | Utah | 84106 | — |
| Site 092 | Norfolk | Virginia | 23507 | — |
| Site 026 | Virginia Beach | Virginia | 23454 | — |
| Site 066 | Bellevue | Washington | 98007 | — |
| Site 057 | Renton | Washington | 98057 | — |
| Site 065 | Seattle | Washington | 98122 | — |
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 NCT01709214, 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 Jul 15, 2021 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01709214 live on ClinicalTrials.gov.