A Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
Public ClinicalTrials.gov record NCT03122860. 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 Phase 2, 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase 2 study is a placebo-controlled, double-blind, parallel group study of four concentrations of SM04690 (0.03, 0.07, 0.15, and 0.23 mg per 2 mL injection) injected intraarticularly (IA) into the target knee joint of subjects with moderately to severely symptomatic osteoarthritis (OA). Based on previous studies of SM04690, key phenotypes of laterality (unilateral vs bilateral) as well as chronic pain (as measured by the Widespread Pain Index) were identified as confounding variables impacting the overall assessment of both radiologic and clinical efficacy outcomes. The design of SM04690-OA-04 is based upon previous study designs while assessing strategies to combat the confounding impact of laterality and chronic pain. To evaluate the effect of IA vehicle injection on patient-reported outcomes (PRO) such as pain, stiffness, and function in OA, this study also includes one cohort that receives a 2 mL IA injection of vehicle (placebo), and one cohort that receives a sham injection (i.e., a needle stick with 0 mL vehicle injected).
Study identification
- NCT ID
- NCT03122860
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 700 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 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
- Apr 24, 2017 (Actual)
- Primary completion
- Apr 30, 2018 (Actual)
- Completion
- Apr 30, 2018 (Actual)
- Last update posted
- Jun 11, 2021
2017 – 2018
United States locations
- U.S. sites
- 74
- U.S. states
- 28
- U.S. cities
- 71
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Anniston | Alabama | 36207 | — |
| Research Site | Birmingham | Alabama | 35216 | — |
| Research Site | Mobile | Alabama | 36608 | — |
| Research Site | Chandler | Arizona | 85224 | — |
| Research Site | Phoenix | Arizona | 85018 | — |
| Research Site | Phoenix | Arizona | 85053 | — |
| Research Site | Tucson | Arizona | 85712 | — |
| Research Site | Anaheim | California | 92801 | — |
| Research Site | Canoga Park | California | 91303 | — |
| Research Site | Carmichael | California | 95608 | — |
| Research Site | Cerritos | California | 90703 | — |
| Research Site | El Cajon | California | 92020 | — |
| Research Site | Gold River | California | 95670 | — |
| Research Site | La Mesa | California | 91942 | — |
| Research Site | Los Angeles | California | 90036 | — |
| Research Site | Rancho Mirage | California | 92270 | — |
| Research Site | Sacramento | California | 95817 | — |
| Research Site | San Diego | California | 92103 | — |
| Research Site | San Marcos | California | 92078 | — |
| Research Site | Spring Valley | California | 91978 | — |
| Research Site | Boulder | Colorado | 80301 | — |
| Research Site | Stamford | Connecticut | 06905 | — |
| Research Site | Trumbull | Connecticut | 06606 | — |
| Research Site | Waterbury | Connecticut | 06708 | — |
| Research Site | Clearwater | Florida | 33761 | — |
| Research Site | Coral Gables | Florida | 33134 | — |
| Research Site | DeLand | Florida | 32720 | — |
| Research Site | Edgewater | Florida | 32132 | — |
| Research Site | Lauderdale Lakes | Florida | 33319 | — |
| Research Site | Miami | Florida | 33143 | — |
| Research Site | Pinellas Park | Florida | 33781 | — |
| Research Site | Marietta | Georgia | 30060 | — |
| Research Site | Woodstock | Georgia | 30189 | — |
| Research Site | Chicago | Illinois | 60607 | — |
| Research Site | Evansville | Indiana | 47714 | — |
| Research Site | Newton | Kansas | 67114 | — |
| Research Site | Prairie Village | Kansas | 66208 | — |
| Research Site | Wichita | Kansas | 67205 | — |
| Research Site | Lexington | Kentucky | 40504 | — |
| Research Site | Jefferson | Louisiana | 70121 | — |
| Research Site | Frederick | Maryland | 21702 | — |
| Research Site | Boston | Massachusetts | 02111 | — |
| Research Site | Troy | Michigan | 48085 | — |
| Research Site | City of Saint Peters | Missouri | 63303 | — |
| Research Site | Kansas City | Missouri | 64114 | — |
| Research Site | St Louis | Missouri | 63141 | — |
| Research Site | Lincoln | Nebraska | 68516 | — |
| Research Site | Las Vegas | Nevada | 89119 | — |
| Research Site | Albuquerque | New Mexico | 87102 | — |
| Research Site | Rochester | New York | 14609 | — |
| Research Site | Charlotte | North Carolina | 28209 | — |
| Research Site | Charlotte | North Carolina | 28210 | — |
| Research Site | High Point | North Carolina | 27262 | — |
| Research Site | Salisbury | North Carolina | 28144 | — |
| Research Site | Wilmington | North Carolina | 28401 | — |
| Research Site | Fargo | North Dakota | 58103 | — |
| Research Site | Cincinnati | Ohio | 45224 | — |
| Research Site | Cincinnati | Ohio | 45246 | — |
| Research Site | Cleveland | Ohio | 44122 | — |
| Research Site | Columbus | Ohio | 43213 | — |
| Research Site | Duncansville | Pennsylvania | 16635 | — |
| Research Site | Philadelphia | Pennsylvania | 19152 | — |
| Research Site | State College | Pennsylvania | 16801 | — |
| Research Site | Charleston | South Carolina | 29406 | — |
| Research Site | Mt. Pleasant | South Carolina | 29464 | — |
| Research Site | Rapid City | South Dakota | 57702 | — |
| Research Site | Austin | Texas | 78745 | — |
| Research Site | Bedford | Texas | 76021 | — |
| Research Site | Dallas | Texas | 75231 | — |
| Research Site | Houston | Texas | 77055 | — |
| Research Site | San Angelo | Texas | 76904 | — |
| Research Site | Arlington | Virginia | 22207 | — |
| Research Site | Charlottesville | Virginia | 22911 | — |
| Research Site | Danville | Virginia | 24541 | — |
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 NCT03122860, 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 Jun 11, 2021 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03122860 live on ClinicalTrials.gov.