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A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536833
Recruitment Status : Completed
First Posted : September 1, 2015
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Drug: SM04690
Drug: Placebo
Enrollment 455
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Period Title: Overall Study
Started 112 117 110 116
Completed 103 107 95 97
Not Completed 9 10 15 19
Reason Not Completed
Discontinued Before Treatment             0             0             1             2
Adverse Event             1             3             4             1
Lost to Follow-up             2             1             2             2
Physician Decision             0             0             0             1
Site Terminated by Sponsor             2             2             2             2
Subject Non-Compliance             0             1             1             0
Withdrawal by Subject             4             3             5             11
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo Total
Hide Arm/Group Description Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline Total of all reporting groups
Overall Number of Baseline Participants 112 117 110 116 455
Hide Baseline Analysis Population Description
Baseline Analysis Population is the Intent-to-Treat (ITT) Analysis Set (i.e. all participants who were randomized).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 117 participants 110 participants 116 participants 455 participants
59  (9) 60  (8.2) 61.3  (8.7) 60.7  (8.9) 60.3  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 117 participants 110 participants 116 participants 455 participants
Female
68
  60.7%
60
  51.3%
68
  61.8%
72
  62.1%
268
  58.9%
Male
44
  39.3%
57
  48.7%
42
  38.2%
44
  37.9%
187
  41.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 117 participants 110 participants 116 participants 455 participants
Hispanic or Latino
20
  17.9%
23
  19.7%
17
  15.5%
21
  18.1%
81
  17.8%
Not Hispanic or Latino
92
  82.1%
94
  80.3%
93
  84.5%
95
  81.9%
374
  82.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 117 participants 110 participants 116 participants 455 participants
American Indian or Alaska Native
0
   0.0%
1
   0.9%
0
   0.0%
2
   1.7%
3
   0.7%
Asian
1
   0.9%
0
   0.0%
2
   1.8%
0
   0.0%
3
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.9%
1
   0.2%
Black or African American
18
  16.1%
14
  12.0%
12
  10.9%
10
   8.6%
54
  11.9%
White
92
  82.1%
102
  87.2%
96
  87.3%
102
  87.9%
392
  86.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.9%
0
   0.0%
0
   0.0%
1
   0.9%
2
   0.4%
Kellgren-Lawrence Grade   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 117 participants 110 participants 116 participants 455 participants
Grade 2
38
  33.9%
43
  36.8%
39
  35.5%
41
  35.3%
161
  35.4%
Grade 3
74
  66.1%
74
  63.2%
70
  63.6%
74
  63.8%
292
  64.2%
Grade 4
0
   0.0%
0
   0.0%
1
   0.9%
1
   0.9%
2
   0.4%
[1]
Measure Description: Participants' knee osteoarthritis was graded in accordance with the following definitions of Kellgren-Lawrence Grade: None (Grade 0) - Normal appearance of the knee; Doubtful (Grade 1): Doubtful narrowing of joint space and possible osteophytic lipping; Minimal (Grade 2): Definite osteophytes and possible narrowing of joint space; Moderate (Grade 3): Moderate multiple osteophytes, definite narrowing of the joint space, some sclerosis and possible deformity of bone ends; Severe (Grade 4): Large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends.
1.Primary Outcome
Title Change From Baseline Osteoarthritis (OA) Pain in the Target Knee
Hide Description Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 13. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 112 117 110 116
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-23.3  (2.2) -23.5  (2.1) -21.3  (2.2) -22.1  (2.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.575
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.46
Confidence Interval (2-Sided) 95%
-6.57 to 3.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.643
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.27
Confidence Interval (2-Sided) 95%
-6.63 to 4.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.901
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-5.07 to 5.75
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline OA Pain in the Target Knee
Hide Description Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 26. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 112 117 110 116
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-24.7  (2.3) -27.3  (2.0) -23.3  (2.1) -24.4  (2.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.271
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.99
Confidence Interval (2-Sided) 95%
-8.31 to 2.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.898
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-6.06 to 5.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.795
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
-4.74 to 6.18
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline OA Function in the Target Knee
Hide Description Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 13. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 112 117 110 116
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-24.5  (2.1) -26.3  (2.0) -22.6  (2.1) -22.8  (2.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.283
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.74
Confidence Interval (2-Sided) 95%
-7.74 to 2.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.588
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.48
Confidence Interval (2-Sided) 95%
-6.82 to 3.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.853
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-5.76 to 4.76
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline OA Function in the Target Knee
Hide Description Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 26. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 112 117 110 116
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-25.1  (2.2) -28.6  (2.0) -24.1  (2.0) -25.1  (2.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.292
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.89
Confidence Interval (2-Sided) 95%
-8.26 to 2.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.931
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-5.34 to 5.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.878
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
-4.92 to 5.76
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline OA Disease Activity as Assessed by the Patient
Hide Description Change from baseline OA disease activity as assessed by the Patient Global Assessment at Week 13. The Patient Global Assessment was completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.
Time Frame Baseline and Week 13
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 112 117 110 116
Least Squares Mean (Standard Error)
Unit of Measure: mm
-18.1  (2.3) -13.7  (2.3) -14.6  (2.6) -14.0  (2.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.648
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
-3.83 to 6.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.209
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.14
Confidence Interval (2-Sided) 95%
-8.02 to 1.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.915
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
-4.78 to 5.33
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline OA Disease Activity as Assessed by the Patient
Hide Description Change from baseline OA disease activity as assessed by the Patient Global Assessment at Week 26. The Patient Global Assessment was completed using a 100 mm visual analog scale (VAS) adapted from the Patient Assessment Form © 1999, American College of Rheumatology. The subject rated how well he/she was doing, considering all the ways in which illness and health conditions may affected him/her. The VAS scale was anchored by "Very Well" on the left (scored as 0) and "Very Poorly" on the right (scored as 100). Higher scores indicated poorer disease assessment by the subject.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 112 117 110 116
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-21.3  (2.4) -17.5  (2.3) -17.2  (2.6) -16.6  (2.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.969
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-5.16 to 5.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.174
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.64
Confidence Interval (2-Sided) 95%
-8.89 to 1.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.908
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
-4.97 to 5.59
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Medial Joint Space Width of Target Knee
Hide Description Change from baseline in medial joint space width as documented by X-ray of the target knee at Week 26.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 112 117 110 116
Least Squares Mean (Standard Error)
Unit of Measure: mm
-0.07  (0.06) -0.11  (0.08) -0.02  (0.06) -0.20  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.334
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.10 to 0.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.04 to 0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.19
Confidence Interval (2-Sided) 95%
0.02 to 0.36
Estimation Comments [Not Specified]
8.Other Pre-specified Outcome
Title Change From Baseline OA Pain in the Target Knee
Hide Description Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 52. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 112 117 110 116
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-24.7  (2.5) -29.0  (2.1) -25.5  (2.1) -26.7  (2.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.405
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.38
Confidence Interval (2-Sided) 95%
-8.00 to 3.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.552
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.89
Confidence Interval (2-Sided) 95%
-4.37 to 8.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.763
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
-4.91 to 6.68
Estimation Comments [Not Specified]
9.Other Pre-specified Outcome
Title Change From Baseline OA Function in the Target Knee
Hide Description Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 52. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 112 117 110 116
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-24.1  (2.5) -29.6  (2.0) -24.9  (2.1) -25.1  (2.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.173
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.90
Confidence Interval (2-Sided) 95%
-9.50 to 1.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.724
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
-5.12 to 7.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.914
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-6.17 to 5.53
Estimation Comments [Not Specified]
10.Other Pre-specified Outcome
Title Change From Baseline in Medial Joint Space Width of Target Knee
Hide Description Change from baseline in medial joint space width as documented by X-ray of the target knee at Week 52.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 112 117 110 116
Least Squares Mean (Standard Error)
Unit of Measure: mm
-0.04  (0.06) -0.09  (0.06) -0.16  (0.07) -0.14  (0.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.529
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.12 to 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.259
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.08 to 0.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.807
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.21 to 0.16
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Change From Baseline OA Pain in the Target Knee [Unilateral Symptomatic OA]
Hide Description Change from baseline OA pain in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) pain subscore (WOMAC Pain) at Week 52. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Pain subscore is reported ranging from 0 to 100.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with unilateral symptomatic OA in the ITT Analysis Set.
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 45 35 45 39
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-28.6  (3.5) -30.1  (3.2) -26.6  (3.1) -23.8  (3.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.73
Confidence Interval (2-Sided) 95%
-17.44 to -0.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.211
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.03
Confidence Interval (2-Sided) 95%
-15.49 to 3.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.254
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.23
Confidence Interval (2-Sided) 95%
-14.24 to 3.78
Estimation Comments [Not Specified]
12.Other Pre-specified Outcome
Title Change From Baseline OA Function in the Target Knee [Unilateral Symptomatic OA]
Hide Description Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numeric Rating Scale (NRS 3.1) physical functioning subscore (WOMAC Function) at Week 52. The WOMAC is a widely-used, proprietary outcome measurement tool used by health professionals to evaluate the condition of subjects with OA of the knee and hip, including pain (5 questions), stiffness (2 questions), and physical functioning (17 questions) of the joints. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 10 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore is reported ranging from 0 to 100.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with unilateral symptomatic OA in the ITT Analysis Set.
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 45 35 45 39
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-29.0  (3.9) -29.9  (3.4) -25.6  (3.1) -21.5  (3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.26
Confidence Interval (2-Sided) 95%
-19.82 to -0.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.170
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.07
Confidence Interval (2-Sided) 95%
-17.18 to 3.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.171
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.29
Confidence Interval (2-Sided) 95%
-15.33 to 2.74
Estimation Comments [Not Specified]
13.Other Pre-specified Outcome
Title Change From Baseline in Medial Joint Space Width of Target Knee [Unilateral Symptomatic OA]
Hide Description Change from baseline in medial joint space width as documented by X-ray of the target knee at Week 52.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with unilateral symptomatic OA in the ITT Analysis Set.
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo
Hide Arm/Group Description:
Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension
Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline
Overall Number of Participants Analyzed 45 35 45 39
Least Squares Mean (Standard Error)
Unit of Measure: mm
0.03  (0.10) 0.19  (0.12) -0.22  (0.11) -0.21  (0.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.07 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.06 to 0.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 0.03 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.24
Confidence Interval (2-Sided) 95%
-0.07 to 0.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 0.23 mg SM04690, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.789
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.35 to 0.26
Estimation Comments [Not Specified]
Time Frame Data regarding treatment-emergent adverse events (TEAEs) was collected in this study. TEAEs are events that were not present prior to study medication injection or, if present prior to study medication injection, had worsened in severity. The reporting period for TEAEs started after the injection of study medication on Study Visit Day 1 through Week 52 (End of Study)/Early Termination.
Adverse Event Reporting Description Safety Analyses Set: All participants who were exposed to SM04690 or placebo. Safety was assessed using the actual treatment.
 
Arm/Group Title 0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo Other
Hide Arm/Group Description Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension Single intra-articular injection of SM04690 0 mg in 2 mL phosphate buffered saline Single intra-articular injection of an unidentified dose of SM04690 or Placebo due to incorrectly performed dilution or documentation by a pharmacist.
All-Cause Mortality
0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo Other
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/111 (0.00%)      0/114 (0.00%)      0/104 (0.00%)      0/108 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo Other
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/111 (4.50%)      4/114 (3.51%)      4/104 (3.85%)      3/108 (2.78%)      1/15 (6.67%)    
Cardiac disorders           
Acute myocardial infarction  1  1/111 (0.90%)  1 1/114 (0.88%)  1 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Aortic valve incompetence  1  0/111 (0.00%)  0 1/114 (0.88%)  1 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Atrial fibrillation  1  0/111 (0.00%)  0 1/114 (0.88%)  1 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Congenital, familial and genetic disorders           
Atrial septal defect  1  0/111 (0.00%)  0 1/114 (0.88%)  1 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Gastrointestinal disorders           
Gastroesophageal reflux disease  1  1/111 (0.90%)  1 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
General disorders           
Non-cardiac chest pain  1  0/111 (0.00%)  0 0/114 (0.00%)  0 1/104 (0.96%)  1 0/108 (0.00%)  0 1/15 (6.67%)  1
Hepatobiliary disorders           
Cholecystitis acute  1  0/111 (0.00%)  0 1/114 (0.88%)  1 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Infections and infestations           
Cellulitis  1  1/111 (0.90%)  1 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Diverticulitis  1  1/111 (0.90%)  1 1/114 (0.88%)  1 1/104 (0.96%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0
Influenza  1  1/111 (0.90%)  1 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Pyelonephritis  1  0/111 (0.00%)  0 1/114 (0.88%)  1 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Injury, poisoning and procedural complications           
Patella fracture  1  0/111 (0.00%)  0 0/114 (0.00%)  0 1/104 (0.96%)  2 1/108 (0.93%)  1 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Osteoarthritis  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Breast cancer  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Gallbladder adenocarcinoma  1  0/111 (0.00%)  0 1/114 (0.88%)  1 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Nervous system disorders           
Myelitis transverse  1  1/111 (0.90%)  1 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Renal and urinary disorders           
Nephrolithiasis  1  0/111 (0.00%)  0 1/114 (0.88%)  1 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Reproductive system and breast disorders           
Benign prostatic hyperplasia  1  0/111 (0.00%)  0 1/114 (0.88%)  1 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Uterine prolapse  1  0/111 (0.00%)  0 0/114 (0.00%)  0 1/104 (0.96%)  1 0/108 (0.00%)  0 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Pulmonary embolism  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 1/108 (0.93%)  1 0/15 (0.00%)  0
Vascular disorders           
Aortic aneurysm  1  0/111 (0.00%)  0 1/114 (0.88%)  1 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Arteriosclerosis  1  0/111 (0.00%)  0 1/114 (0.88%)  1 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
Hypertensive crisis  1  1/111 (0.90%)  1 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 0/15 (0.00%)  0
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0.03 mg SM04690 0.07 mg SM04690 0.23 mg SM04690 Placebo Other
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/111 (22.52%)      23/114 (20.18%)      19/104 (18.27%)      18/108 (16.67%)      11/15 (73.33%)    
Blood and lymphatic system disorders           
Anaemia  1  0/111 (0.00%)  0 1/114 (0.88%)  1 1/104 (0.96%)  1 0/108 (0.00%)  0 1/15 (6.67%)  1
Ear and labyrinth disorders           
Vertigo  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Eye disorders           
Visual acuity reduced  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Gastrointestinal disorders           
Hiatus hernia  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Large intestine polyp  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Oesophageal motility disorder  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Oesophagitis  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
General disorders           
Oedema  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Infections and infestations           
Nasopharyngitis  1  4/111 (3.60%)  4 3/114 (2.63%)  3 3/104 (2.88%)  3 0/108 (0.00%)  0 1/15 (6.67%)  1
Tooth abscess  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Upper respiratory tract infection  1  5/111 (4.50%)  5 2/114 (1.75%)  2 1/104 (0.96%)  1 3/108 (2.78%)  3 1/15 (6.67%)  1
Injury, poisoning and procedural complications           
Joint injury  1  2/111 (1.80%)  2 0/114 (0.00%)  0 1/104 (0.96%)  1 1/108 (0.93%)  1 2/15 (13.33%)  2
Meniscus injury  1  2/111 (1.80%)  2 2/114 (1.75%)  2 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Metabolism and nutrition disorders           
Diabetes mellitus  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Hypercholesterolaemia  1  1/111 (0.90%)  1 0/114 (0.00%)  0 1/104 (0.96%)  1 1/108 (0.93%)  1 1/15 (6.67%)  1
Hyperlipidaemia  1  0/111 (0.00%)  0 1/114 (0.88%)  1 0/104 (0.00%)  0 1/108 (0.93%)  1 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia  1  13/111 (11.71%)  16 13/114 (11.40%)  14 9/104 (8.65%)  13 10/108 (9.26%)  12 4/15 (26.67%)  6
Joint crepitation  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Muscle spasms  1  1/111 (0.90%)  1 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Musculoskeletal stiffness  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  2
Patellofemoral pain syndrome  1  0/111 (0.00%)  0 0/114 (0.00%)  0 1/104 (0.96%)  1 0/108 (0.00%)  0 1/15 (6.67%)  1
Nervous system disorders           
Decreased vibratory sense  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Headache  1  0/111 (0.00%)  0 3/114 (2.63%)  6 2/104 (1.92%)  2 4/108 (3.70%)  4 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders           
Asthma  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
Vascular disorders           
Varicose vein  1  0/111 (0.00%)  0 0/114 (0.00%)  0 0/104 (0.00%)  0 0/108 (0.00%)  0 1/15 (6.67%)  1
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Swearingen, PhD, VP of Clinical Outcomes and Analytics
Organization: Samumed
Phone: 858.926.2952
EMail: chris@samumed.com
Layout table for additonal information
Responsible Party: Samumed LLC
ClinicalTrials.gov Identifier: NCT02536833    
Other Study ID Numbers: SM04690-OA-02
First Submitted: August 28, 2015
First Posted: September 1, 2015
Results First Submitted: July 23, 2020
Results First Posted: September 16, 2020
Last Update Posted: September 16, 2020