Trial Outcomes & Findings for A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain (NCT NCT03660943)
NCT ID: NCT03660943
Last Updated: 2022-07-21
Results Overview
The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The pain dimension includes 5 items about the amount of pain experienced doing various activities (walking, stair climbing, nocturnal, at rest, weight bearing). The score ranges from 0 to 50.
COMPLETED
PHASE3
332 participants
Baseline, Week 12
2022-07-21
Participant Flow
Participant milestones
| Measure |
Placebo
Matching placebo of 2.0 mL for IA injection
|
CNTX-4975-05 (Trans-capsaicin)
Pre-filled glass syringes administered as a single 2.0 mL IA injection
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
187
|
|
Overall Study
Treated
|
140
|
184
|
|
Overall Study
COMPLETED
|
109
|
134
|
|
Overall Study
NOT COMPLETED
|
36
|
53
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo of 2.0 mL for IA injection
|
CNTX-4975-05 (Trans-capsaicin)
Pre-filled glass syringes administered as a single 2.0 mL IA injection
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
|
Overall Study
Protocol Violation
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
8
|
15
|
|
Overall Study
Lack of Efficacy
|
9
|
12
|
|
Overall Study
WITHDRAWAL FOR OTHER TREATMENT; UNABLE TO COMPLETE INJECTION PROCEDURES
|
4
|
13
|
Baseline Characteristics
A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=140 Participants
Matching placebo of 2.0 mL for IA injection
|
CNTX-4975-05 (Trans-capsaicin)
n=184 Participants
Pre-filled glass syringes administered as a single 2.0 mL IA injection
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 8.59 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 8.80 • n=7 Participants
|
62.8 years
STANDARD_DEVIATION 8.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Body Mass Index (kg/m^2)
|
32.40 kg/m^2
STANDARD_DEVIATION 5.265 • n=5 Participants
|
32.37 kg/m^2
STANDARD_DEVIATION 5.895 • n=7 Participants
|
32.38 kg/m^2
STANDARD_DEVIATION 5.623 • n=5 Participants
|
|
Study Baseline WOMAC A (Pain) Domain Score (range 0-50)
|
31.3 score on a scale
STANDARD_DEVIATION 7.2 • n=5 Participants
|
31.6 score on a scale
STANDARD_DEVIATION 7.36 • n=7 Participants
|
31.5 score on a scale
STANDARD_DEVIATION 7.28 • n=5 Participants
|
|
Study Baseline WOMAC B (Stiffness) Domain Score (range 0-20)
|
13.2 score on a scale
STANDARD_DEVIATION 3.41 • n=5 Participants
|
13.2 score on a scale
STANDARD_DEVIATION 3.15 • n=7 Participants
|
13.2 score on a scale
STANDARD_DEVIATION 3.26 • n=5 Participants
|
|
Study Baseline WOMAC C (Function) Domain Score (range 0-170)
|
107.9 score on a scale
STANDARD_DEVIATION 26.71 • n=5 Participants
|
109.5 score on a scale
STANDARD_DEVIATION 25.89 • n=7 Participants
|
108.8 score on a scale
STANDARD_DEVIATION 26.22 • n=5 Participants
|
|
Average Weekly Pain with Walking NPRS (0-10) Score
|
6.933 score on a scale
STANDARD_DEVIATION 1.021 • n=5 Participants
|
7.013 score on a scale
STANDARD_DEVIATION 0.9950 • n=7 Participants
|
6.978 score on a scale
STANDARD_DEVIATION 1.0055 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The intent to treat (ITT) population included all randomized subjects who received any amount of investigational product and all observed data
The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The pain dimension includes 5 items about the amount of pain experienced doing various activities (walking, stair climbing, nocturnal, at rest, weight bearing). The score ranges from 0 to 50.
Outcome measures
| Measure |
Placebo
n=125 Participants
Matching placebo of 2.0 mL for IA injection
|
CNTX-4975-05
n=164 Participants
Pre-filled glass syringes administered as a single 2.0 mL IA injection
|
|---|---|---|
|
Mean Change From Baseline in WOMAC A (Pain) Dimension
|
-14.13 score on a scale
Standard Deviation 12.217
|
-17.16 score on a scale
Standard Deviation 12.266
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The intent to treat (ITT) population included all randomized subjects who received any amount of investigational product and all observed data as collected in the daily diary
Average daily OA pain in the index knee while walking was evaluated using a 0 to 10 Numerical Pain Rating Scale (NPRS) (0 = no pain and 10 = worst possible pain). 0 was the best score and 10 was the worst score. Subjects used an ePRO at bedtime (9:00 PM ± 3 hours) to record on a daily basis their average daily OA knee pain score with walking during the previous 24 hours.
Outcome measures
| Measure |
Placebo
n=128 Participants
Matching placebo of 2.0 mL for IA injection
|
CNTX-4975-05
n=170 Participants
Pre-filled glass syringes administered as a single 2.0 mL IA injection
|
|---|---|---|
|
Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
|
-2.99 score on a scale
Standard Error 0.213
|
-3.41 score on a scale
Standard Error 0.197
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The intent to treat (ITT) population included all randomized subjects who received any amount of investigational product and all observed data
The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The stiffness dimension has 2 items: joint stiffness upon wakening and joint stiffness later in the day. The score ranges from 0 to 20.
Outcome measures
| Measure |
Placebo
n=125 Participants
Matching placebo of 2.0 mL for IA injection
|
CNTX-4975-05
n=164 Participants
Pre-filled glass syringes administered as a single 2.0 mL IA injection
|
|---|---|---|
|
Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension
|
-5.36 score on a scale
Standard Error 0.434
|
-6.58 score on a scale
Standard Error 0.404
|
SECONDARY outcome
Timeframe: Baseline, Week12Population: The intent to treat (ITT) population included all randomized subjects who received any amount of investigational product and all observed data
The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme). The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome. The function dimension asks about the degree of difficulty in doing 17 activities due to the reference joint. The score ranges from 0 to 170.
Outcome measures
| Measure |
Placebo
n=125 Participants
Matching placebo of 2.0 mL for IA injection
|
CNTX-4975-05
n=164 Participants
Pre-filled glass syringes administered as a single 2.0 mL IA injection
|
|---|---|---|
|
Mean Change From Study Baseline in WOMAC C (Function) Dimension
|
-49.03 score on a scale
Standard Error 3.541
|
-57.02 score on a scale
Standard Error 3.307
|
Adverse Events
Placebo
CNTX-4975-05 (Trans-capsaicin)
Serious adverse events
| Measure |
Placebo
n=140 participants at risk
Matching placebo of 2.0 mL for IA injection
|
CNTX-4975-05 (Trans-capsaicin)
n=184 participants at risk
Pre-filled glass syringes administered as a single 2.0 mL IA injection
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/140 • 1 Year
|
1.1%
2/184 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.71%
1/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Cardiac disorders
Angina unstable
|
0.71%
1/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Cardiac disorders
Coronary artery disease
|
0.71%
1/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.71%
1/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.71%
1/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Infections and infestations
Bronchitis
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Infections and infestations
Diverticulitis
|
0.71%
1/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Infections and infestations
Peritoneal abscess
|
0.71%
1/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Infections and infestations
Peritoneal bacterial
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.71%
1/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.71%
1/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.71%
1/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Vascular disorders
Aortic aneurysm
|
0.71%
1/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.71%
1/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/140 • 1 Year
|
0.54%
1/184 • 1 Year
|
Other adverse events
| Measure |
Placebo
n=140 participants at risk
Matching placebo of 2.0 mL for IA injection
|
CNTX-4975-05 (Trans-capsaicin)
n=184 participants at risk
Pre-filled glass syringes administered as a single 2.0 mL IA injection
|
|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.6%
5/140 • 1 Year
|
7.1%
13/184 • 1 Year
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
6/140 • 1 Year
|
2.2%
4/184 • 1 Year
|
|
Infections and infestations
Bronchitis
|
1.4%
2/140 • 1 Year
|
3.3%
6/184 • 1 Year
|
|
Infections and infestations
Sinusitis
|
2.1%
3/140 • 1 Year
|
2.7%
5/184 • 1 Year
|
|
Infections and infestations
Urinary tract infection
|
2.1%
3/140 • 1 Year
|
2.2%
4/184 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.71%
1/140 • 1 Year
|
5.4%
10/184 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.71%
1/140 • 1 Year
|
2.2%
4/184 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.71%
1/140 • 1 Year
|
2.2%
4/184 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
4/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.1%
3/140 • 1 Year
|
0.00%
0/184 • 1 Year
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.71%
1/140 • 1 Year
|
3.8%
7/184 • 1 Year
|
|
Nervous system disorders
Headache
|
2.1%
3/140 • 1 Year
|
2.2%
4/184 • 1 Year
|
|
Gastrointestinal disorders
Nausea
|
0.71%
1/140 • 1 Year
|
2.7%
5/184 • 1 Year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/140 • 1 Year
|
2.2%
4/184 • 1 Year
|
Additional Information
Director of Clinical Operations
Centrexion Therapeutics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place