Trial | NCT02095548  Report issue

Title

Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)
A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sm04690 ...

  • Study Participants

    61
The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.
Study Started
Mar 31
2014
Primary Completion
Sep 30
2015
Study Completion
Sep 30
2015
Last Update
Dec 10
2015
Estimate

Drug SM04690, 0.03mg/2mL

Drug SM04690, 0.07mg/2mL

Drug SM04690, 0.23mg/2mL

Drug Placebo

SM04690, 0.03mg/2mL Experimental

Single, intra-articular injection of SM04690, 0.03mg/2mL

SM04690, 0.07mg/2mL Experimental

Single, intra-articular injection of SM04690, 0.07mg/2mL

SM04690, 0.23mg/2mL Experimental

Single, intra-articular injection of SM04690, 0.23mg/2mL

Placebo Placebo Comparator

Single, intra-articular injection of placebo

Criteria 

Inclusion Criteria:

Diagnosed with primary OA in target knee by American College of Rheumatology (ACR) criteria
Screening pain criteria sufficient as assessed by WOMAC and VAS scores
Ability to read and understand the informed consent

Exclusion Criteria:

Women who are pregnant or lactating or child bearing potential, men must use a barrier method of contraception
Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
Body mass index >40
Major knee surgery in the target knee within 12 months prior to study or planned surgery during the study period
History of malignancy within the last 5 years
Participation in a clinical research trial within 12 weeks prior
Treatment of the target knee with intra-articular steroids within 2 months or hyaluronic acid derivatives within 6 months
Effusion of the target knee requiring aspiration within 3 months
Use of electrotherapy or acupuncture for OA within 4 weeks
Significant and clinically evident misalignment of the target knee
Any known active infections
Any chronic condition that has not been well controlled for a minimum of 3 months
No Results Posted