Trial Outcomes & Findings for An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA (NCT NCT03661996)

NCT ID: NCT03661996

Last Updated: 2022-03-09

Results Overview

A composite score was calculated for each of the 5 treatment regimens by summing the scores of three assessments: (1) procedure pain 30 minutes after injection of CNTX-4975-05 on a 0-4 scale, 0 was best indicating no procedure pain, 4 was worst indicating severe procedure pain; (2) assessment of subjects' satisfaction with the regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied), 1 was worst and 7 was best; and (3) assessment of investigators' satisfaction with the regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied), 1 was worst and 7 was best. The procedure pain at 30 minutes was reversed to a 1-7 scale so 7 was best indicating no procedure pain and 1 was worst indicating severe procedure pain. The three assessments were summed for a total score from 3-21, 3 being the worst outcome and 21 being the best outcome. The geometric mean of the scores was derived for each group. All assessments were administered on Day 1 (Baseline).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

854 participants

Primary outcome timeframe

Day 1 assessments

Results posted on

2022-03-09

Participant Flow

Subjects were recruited between 18 September 2018 and 22 October 2019

Participant milestones

Participant milestones
Measure	Group 1. Breg Cooling Control Breg Cooler (total cool time at least 85 minutes) with IA injection of 2% lidocaine followed by a second IA injection CNTX-4975	Group 2. Gel Pack Cooling Gel Pack Cooling (total cool time at least 60 minutes) with IA injection of 2% lidocaine followed by a second IA injection CNTX-4975	Group 3. Shortened Gel Pack Cooling Gel pack cooling (total cool time at least 35 minutes) with IA injection of 2% lidocaine followed by a second IA injection CNTX-4975	Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine Gel pack cooling (total cool time at least 45 minutes) with a combined single IA injection of 2% lidocaine followed by CNTX-4975	Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine Gel pack cooling (total cool time at least 45 minutes) with a combined single IA injection of 1% lidocaine followed by CNTX-4975
Overall Study STARTED	162	180	176	163	173
Overall Study Treated	162	179	175	160	172
Overall Study COMPLETED	150	172	170	150	159
Overall Study NOT COMPLETED	12	8	6	13	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1. Breg Cooling Control Breg Cooler (total cool time at least 85 minutes) with IA injection of 2% lidocaine followed by a second IA injection CNTX-4975	Group 2. Gel Pack Cooling Gel Pack Cooling (total cool time at least 60 minutes) with IA injection of 2% lidocaine followed by a second IA injection CNTX-4975	Group 3. Shortened Gel Pack Cooling Gel pack cooling (total cool time at least 35 minutes) with IA injection of 2% lidocaine followed by a second IA injection CNTX-4975	Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine Gel pack cooling (total cool time at least 45 minutes) with a combined single IA injection of 2% lidocaine followed by CNTX-4975	Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine Gel pack cooling (total cool time at least 45 minutes) with a combined single IA injection of 1% lidocaine followed by CNTX-4975
Overall Study Adverse Event	0	0	1	1	0
Overall Study Lost to Follow-up	5	1	2	2	6
Overall Study Physician Decision	1	1	1	2	0
Overall Study Protocol Violation	0	0	0	0	1
Overall Study Withdrawal by Subject	3	5	1	7	7
Overall Study Sponsors Decision	2	0	0	0	0
Overall Study Other	1	1	1	1	0

Baseline Characteristics

An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1. Breg Cooling Control n=162 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 15 minutes later. The subject was cooled with the Breg ice water pump and circumferential knee wrap for 15 minutes before lidocaine injection, followed by 30 minutes before the CNTX-4975-05 injection, and for at least 30 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 2. Gel Pack Cooling n=179 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 10 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 40 minutes before the lidocaine injection, followed by 10 minutes before the CNTX-4975-05 injection, and for at least 10 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 3. Shortened Gel Pack Cooling n=175 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 5 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 30 minutes before the lidocaine injection, followed by 5 minutes before the CNTX-4975-05 injection, and with no required cooling after the CNTX-4975-05 injection, but up to 90 minutes of cooling as needed.	Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine n=160 Participants The subject received intra-articular injections from a single needle of 2% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.	Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine n=172 Participants The subject received intra-articular injections from a single needle of 1% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.	Total n=848 Participants Total of all reporting groups
Age, Continuous	62.2 Years STANDARD_DEVIATION 9.5 • n=5 Participants	61.8 Years STANDARD_DEVIATION 8.8 • n=7 Participants	63.9 Years STANDARD_DEVIATION 9.2 • n=5 Participants	62.6 Years STANDARD_DEVIATION 9.4 • n=4 Participants	65.1 Years STANDARD_DEVIATION 9.9 • n=21 Participants	63.1 Years STANDARD_DEVIATION 9.4 • n=8 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	101 Participants n=7 Participants	104 Participants n=5 Participants	99 Participants n=4 Participants	100 Participants n=21 Participants	508 Participants n=8 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	78 Participants n=7 Participants	71 Participants n=5 Participants	61 Participants n=4 Participants	72 Participants n=21 Participants	340 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	69 Participants n=5 Participants	88 Participants n=7 Participants	15 Participants n=5 Participants	17 Participants n=4 Participants	7 Participants n=21 Participants	196 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=5 Participants	91 Participants n=7 Participants	160 Participants n=5 Participants	143 Participants n=4 Participants	164 Participants n=21 Participants	651 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants
Body Mass Index (kg/m^2)	31.21 kg/m^2 STANDARD_DEVIATION 5.349 • n=5 Participants	29.94 kg/m^2 STANDARD_DEVIATION 5.276 • n=7 Participants	31.89 kg/m^2 STANDARD_DEVIATION 7.904 • n=5 Participants	31.54 kg/m^2 STANDARD_DEVIATION 6.083 • n=4 Participants	31.72 kg/m^2 STANDARD_DEVIATION 6.099 • n=21 Participants	31.25 kg/m^2 STANDARD_DEVIATION 6.252 • n=8 Participants
Radiographic Osteoarthritis Type Unilateral	9 Participants n=5 Participants	43 Participants n=7 Participants	31 Participants n=5 Participants	22 Participants n=4 Participants	50 Participants n=21 Participants	155 Participants n=8 Participants
Radiographic Osteoarthritis Type Bilateral	153 Participants n=5 Participants	136 Participants n=7 Participants	144 Participants n=5 Participants	138 Participants n=4 Participants	122 Participants n=21 Participants	693 Participants n=8 Participants
Subject Type Single Knee Injection (Unilateral Mod-Sec OA Knee Pain)	26 Participants n=5 Participants	50 Participants n=7 Participants	71 Participants n=5 Participants	57 Participants n=4 Participants	69 Participants n=21 Participants	273 Participants n=8 Participants
Subject Type Single knee Injection (Non-Index knee PJR/TJR)	3 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	9 Participants n=4 Participants	16 Participants n=21 Participants	52 Participants n=8 Participants
Subject Type Bilateral Knee Injections (Bilateral mod-Sec OA Knee Pain)	133 Participants n=5 Participants	117 Participants n=7 Participants	92 Participants n=5 Participants	94 Participants n=4 Participants	87 Participants n=21 Participants	523 Participants n=8 Participants
KOOS Pain Subscale (Index Knee)	42.42 score on a scale STANDARD_DEVIATION 12.959 • n=5 Participants	44.89 score on a scale STANDARD_DEVIATION 13.397 • n=7 Participants	48.30 score on a scale STANDARD_DEVIATION 15.071 • n=5 Participants	44.70 score on a scale STANDARD_DEVIATION 12.803 • n=4 Participants	44.33 score on a scale STANDARD_DEVIATION 14.201 • n=21 Participants	44.97 score on a scale STANDARD_DEVIATION 13.830 • n=8 Participants
KOOS Symptoms Subscale (Index Knee)	47.69 score on a scale STANDARD_DEVIATION 16.611 • n=5 Participants	50.86 score on a scale STANDARD_DEVIATION 16.161 • n=7 Participants	52.75 score on a scale STANDARD_DEVIATION 17.570 • n=5 Participants	47.97 score on a scale STANDARD_DEVIATION 14.484 • n=4 Participants	51.73 score on a scale STANDARD_DEVIATION 16.227 • n=21 Participants	50.26 score on a scale STANDARD_DEVIATION 16.348 • n=8 Participants
KOOS Function (Daily Living) Subscale (Index Knee)	46.42 score on a scale STANDARD_DEVIATION 13.586 • n=5 Participants	47.81 score on a scale STANDARD_DEVIATION 13.791 • n=7 Participants	52.50 score on a scale STANDARD_DEVIATION 15.846 • n=5 Participants	48.87 score on a scale STANDARD_DEVIATION 14.535 • n=4 Participants	47.05 score on a scale STANDARD_DEVIATION 14.511 • n=21 Participants	48.55 score on a scale STANDARD_DEVIATION 14.607 • n=8 Participants
KOOS Function (Sport and Recreational Activities) Subscale (Index Knee)	25.06 score on a scale STANDARD_DEVIATION 18.485 • n=5 Participants	23.44 score on a scale STANDARD_DEVIATION 19.417 • n=7 Participants	26.29 score on a scale STANDARD_DEVIATION 21.980 • n=5 Participants	30.66 score on a scale STANDARD_DEVIATION 23.312 • n=4 Participants	30.74 score on a scale STANDARD_DEVIATION 24.279 • n=21 Participants	27.12 score on a scale STANDARD_DEVIATION 21.747 • n=8 Participants
KOOS Quality of Life Subscale (Index Knee)	31.98 score on a scale STANDARD_DEVIATION 16.387 • n=5 Participants	36.31 score on a scale STANDARD_DEVIATION 17.450 • n=7 Participants	30.24 score on a scale STANDARD_DEVIATION 16.751 • n=5 Participants	32.93 score on a scale STANDARD_DEVIATION 18.248 • n=4 Participants	27.54 score on a scale STANDARD_DEVIATION 16.620 • n=21 Participants	31.83 score on a scale STANDARD_DEVIATION 17.313 • n=8 Participants
Pain with Walking NPRS (0-10) Score	7.58 score on a scale STANDARD_DEVIATION 1.413 • n=5 Participants	7.23 score on a scale STANDARD_DEVIATION 1.311 • n=7 Participants	6.70 score on a scale STANDARD_DEVIATION 1.585 • n=5 Participants	6.83 score on a scale STANDARD_DEVIATION 1.493 • n=4 Participants	6.91 score on a scale STANDARD_DEVIATION 1.367 • n=21 Participants	7.05 score on a scale STANDARD_DEVIATION 1.467 • n=8 Participants

PRIMARY outcome

Timeframe: Day 1 assessments

Population: The intent to treat (ITT) population included all enrolled subjects who received any amount of CNTX-4975-05. A subject was considered enrolled if they had a Treatment Day 1 study visit.

Outcome measures

Outcome measures
Measure	Group 1. Breg Cooling Control n=162 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 15 minutes later. The subject was cooled with the Breg ice water pump and circumferential knee wrap for 15 minutes before lidocaine injection, followed by 30 minutes before the CNTX-4975-05 injection, and for at least 30 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 2. Gel Pack Cooling n=179 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 10 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 40 minutes before the lidocaine injection, followed by 10 minutes before the CNTX-4975-05 injection, and for at least 10 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 3. Shortened Gel Pack Cooling n=175 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 5 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 30 minutes before the lidocaine injection, followed by 5 minutes before the CNTX-4975-05 injection, and with no required cooling after the CNTX-4975-05 injection, but up to 90 minutes of cooling as needed.	Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine n=160 Participants The subject received intra-articular injections from a single needle of 2% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.	Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine n=172 Participants The subject received intra-articular injections from a single needle of 1% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.
Determination of Optimal Procedure for Administering CNTX-4975-05 With Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction	17.18 score on a scale Standard Error 1.016	18.26 score on a scale Standard Error 1.015	16.48 score on a scale Standard Error 1.016	17.40 score on a scale Standard Error 1.016	16.00 score on a scale Standard Error 1.015

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: The intent to treat (ITT) population included all enrolled subjects who received any amount of CNTX-4975-05.A subject was considered enrolled if they had a Treatment Day 1 study visit.

The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related Quality of Life. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The KOOS was administered on Day 1 (Baseline) and Week 8. Higher scores (or positive change from baseline) indicate improvement.

Outcome measures

Outcome measures
Measure	Group 1. Breg Cooling Control n=260 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 15 minutes later. The subject was cooled with the Breg ice water pump and circumferential knee wrap for 15 minutes before lidocaine injection, followed by 30 minutes before the CNTX-4975-05 injection, and for at least 30 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 2. Gel Pack Cooling n=50 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 10 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 40 minutes before the lidocaine injection, followed by 10 minutes before the CNTX-4975-05 injection, and for at least 10 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 3. Shortened Gel Pack Cooling n=492 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 5 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 30 minutes before the lidocaine injection, followed by 5 minutes before the CNTX-4975-05 injection, and with no required cooling after the CNTX-4975-05 injection, but up to 90 minutes of cooling as needed.	Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine n=381 Participants The subject received intra-articular injections from a single needle of 2% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.	Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine The subject received intra-articular injections from a single needle of 1% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.
Mean Change From Baseline in KOOS "Symptoms" Subscale Score by Subject Type	17.15 score on a scale Standard Error 1.396	20.41 score on a scale Standard Error 3.692	20.05 score on a scale Standard Error 0.981	18.40 score on a scale Standard Error 1.011	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: The intent to treat (ITT) population included all enrolled subjects who received any amount of CNTX-4975-05. A subject was considered enrolled if they had a Treatment Day 1 study visit.

Outcome measures

Outcome measures
Measure	Group 1. Breg Cooling Control n=260 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 15 minutes later. The subject was cooled with the Breg ice water pump and circumferential knee wrap for 15 minutes before lidocaine injection, followed by 30 minutes before the CNTX-4975-05 injection, and for at least 30 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 2. Gel Pack Cooling n=50 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 10 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 40 minutes before the lidocaine injection, followed by 10 minutes before the CNTX-4975-05 injection, and for at least 10 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 3. Shortened Gel Pack Cooling n=488 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 5 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 30 minutes before the lidocaine injection, followed by 5 minutes before the CNTX-4975-05 injection, and with no required cooling after the CNTX-4975-05 injection, but up to 90 minutes of cooling as needed.	Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine n=379 Participants The subject received intra-articular injections from a single needle of 2% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.	Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine The subject received intra-articular injections from a single needle of 1% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.
Mean Change From Baseline in KOOS "Pain" Subscale Score by Subject Type	22.45 score on a scale Standard Error 1.478	23.90 score on a scale Standard Error 4.613	25.62 score on a scale Standard Error 0.865	22.10 score on a scale Standard Error 1.053	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: The intent to treat (ITT) population included all enrolled subjects who received any amount of CNTX-4975-05. A subject was considered enrolled if they had a Treatment Day 1 study visit.

The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related Quality of Life. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The KOOS Pain with Walking is a single question from the KOOS Pain subscale. The KOOS was administered on Day 1 (Baseline) and Week 8. Higher scores (or positive change from baseline) indicate improvement.

Outcome measures

Outcome measures
Measure	Group 1. Breg Cooling Control n=260 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 15 minutes later. The subject was cooled with the Breg ice water pump and circumferential knee wrap for 15 minutes before lidocaine injection, followed by 30 minutes before the CNTX-4975-05 injection, and for at least 30 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 2. Gel Pack Cooling n=50 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 10 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 40 minutes before the lidocaine injection, followed by 10 minutes before the CNTX-4975-05 injection, and for at least 10 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 3. Shortened Gel Pack Cooling n=488 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 5 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 30 minutes before the lidocaine injection, followed by 5 minutes before the CNTX-4975-05 injection, and with no required cooling after the CNTX-4975-05 injection, but up to 90 minutes of cooling as needed.	Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine n=379 Participants The subject received intra-articular injections from a single needle of 2% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.	Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine The subject received intra-articular injections from a single needle of 1% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.
Mean Change From Baseline in KOOS "Pain With Walking" Single Question Score by Subject Type	21.08 score on a scale Standard Error 1.744	25.26 score on a scale Standard Error 6.062	25.85 score on a scale Standard Error 1.035	23.34 score on a scale Standard Error 1.238	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: The intent to treat (ITT) population included all enrolled subjects who received any amount of CNTX-4975-05. A subject was considered enrolled if they had a Treatment Day 1 study visit.

The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related QOL. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The KOOS was administered on Day 1 (Baseline) and Week 8. Higher scores (or positive change from baseline) indicate improvement.

Outcome measures

Outcome measures
Measure	Group 1. Breg Cooling Control n=260 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 15 minutes later. The subject was cooled with the Breg ice water pump and circumferential knee wrap for 15 minutes before lidocaine injection, followed by 30 minutes before the CNTX-4975-05 injection, and for at least 30 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 2. Gel Pack Cooling n=50 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 10 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 40 minutes before the lidocaine injection, followed by 10 minutes before the CNTX-4975-05 injection, and for at least 10 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 3. Shortened Gel Pack Cooling n=487 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 5 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 30 minutes before the lidocaine injection, followed by 5 minutes before the CNTX-4975-05 injection, and with no required cooling after the CNTX-4975-05 injection, but up to 90 minutes of cooling as needed.	Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine n=379 Participants The subject received intra-articular injections from a single needle of 2% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.	Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine The subject received intra-articular injections from a single needle of 1% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.
Mean Change From Baseline in KOOS "Function (Daily Living)" Subscale Score by Subject Type	20.86 score on a scale Standard Error 1.481	25.66 score on a scale Standard Error 4.568	25.57 score on a scale Standard Error 0.861	22.26 score on a scale Standard Error 1.058	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: The intent to treat (ITT) population included all enrolled subjects who received any amount of CNTX-4975-05. A subject was considered enrolled if they had a Treatment Day 1 study visit.

The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related QOL. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The KOOS was administered on Day 1 (Baseline) and Week 8. Higher scores (or positive change from baseline) indicate improvement.

Outcome measures

Outcome measures
Measure	Group 1. Breg Cooling Control n=255 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 15 minutes later. The subject was cooled with the Breg ice water pump and circumferential knee wrap for 15 minutes before lidocaine injection, followed by 30 minutes before the CNTX-4975-05 injection, and for at least 30 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 2. Gel Pack Cooling n=49 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 10 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 40 minutes before the lidocaine injection, followed by 10 minutes before the CNTX-4975-05 injection, and for at least 10 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 3. Shortened Gel Pack Cooling n=482 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 5 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 30 minutes before the lidocaine injection, followed by 5 minutes before the CNTX-4975-05 injection, and with no required cooling after the CNTX-4975-05 injection, but up to 90 minutes of cooling as needed.	Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine n=375 Participants The subject received intra-articular injections from a single needle of 2% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.	Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine The subject received intra-articular injections from a single needle of 1% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.
Mean Change From Baseline in KOOS "Function (Sport and Recreational Activities)" Subscale Score by Subject Type	25.17 score on a scale Standard Error 2.248	33.11 score on a scale Standard Error 5.795	27.80 score on a scale Standard Error 1.233	24.80 score on a scale Standard Error 1.598	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: The intent to treat (ITT) population included all enrolled subjects who received any amount of CNTX-4975-05. A subject was considered enrolled if they had a Treatment Day 1 study visit.

The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related QOL. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The KOOS was administered on Day 1 (Baseline) and Week 8. Higher scores (or positive change from baseline) indicate improvement.

Outcome measures

Outcome measures
Measure	Group 1. Breg Cooling Control n=260 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 15 minutes later. The subject was cooled with the Breg ice water pump and circumferential knee wrap for 15 minutes before lidocaine injection, followed by 30 minutes before the CNTX-4975-05 injection, and for at least 30 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 2. Gel Pack Cooling n=50 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 10 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 40 minutes before the lidocaine injection, followed by 10 minutes before the CNTX-4975-05 injection, and for at least 10 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 3. Shortened Gel Pack Cooling n=488 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 5 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 30 minutes before the lidocaine injection, followed by 5 minutes before the CNTX-4975-05 injection, and with no required cooling after the CNTX-4975-05 injection, but up to 90 minutes of cooling as needed.	Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine n=379 Participants The subject received intra-articular injections from a single needle of 2% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.	Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine The subject received intra-articular injections from a single needle of 1% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.
Mean Change From Baseline in KOOS "Knee-Related Quality of Life" Subscale Score by Subject Type	22.10 score on a scale Standard Error 1.898	16.75 score on a scale Standard Error 6.255	21.52 score on a scale Standard Error 1.062	19.40 score on a scale Standard Error 1.365	—

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: The intent to treat (ITT) population included all enrolled subjects who received any amount of CNTX-4975-05. A subject was considered enrolled if they had a Treatment Day 1 study visit.

The pain with walking Numerical Pain Rating Scale (NPRS) (0-10, 0 being no pain, 10 being greatest pain) collected subjects' average pain with walking over the past 24 hours. Subjects recorded the pain in their target knee, either the index knee or additionally the non-index knee in the case of bilateral subjects. The NPRS was collected at Day 1 (Baseline) and Week 8. Lower scores (or negative change from baseline) indicate improvement

Outcome measures

Outcome measures
Measure	Group 1. Breg Cooling Control n=260 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 15 minutes later. The subject was cooled with the Breg ice water pump and circumferential knee wrap for 15 minutes before lidocaine injection, followed by 30 minutes before the CNTX-4975-05 injection, and for at least 30 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 2. Gel Pack Cooling n=51 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 10 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 40 minutes before the lidocaine injection, followed by 10 minutes before the CNTX-4975-05 injection, and for at least 10 minutes and up to 90 minutes after the CNTX-4975-05 injection as needed.	Group 3. Shortened Gel Pack Cooling n=491 Participants The subject received intra-articular injections from separate needles of 2% lidocaine without epinephrine followed by CNTX-4975-05 5 minutes later. The subject was cooled with the Elasto-Gel circumferential knee wrap for 30 minutes before the lidocaine injection, followed by 5 minutes before the CNTX-4975-05 injection, and with no required cooling after the CNTX-4975-05 injection, but up to 90 minutes of cooling as needed.	Group 4. Single Needle Injection Gel Pack Cooling - 2% Lidocaine n=414 Participants The subject received intra-articular injections from a single needle of 2% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.	Group 5. Single Needle Injection Gel Pack Cooling - 1% Lidocaine The subject received intra-articular injections from a single needle of 1% lidocaine without epinephrine and CNTX-4975-05, with up to 3 minutes in between injections. The subject was cooled with the Elasto-Gel circumferential knee wrap for 45 minutes before the single needle injection of lidocaine and CNTX-4975-05. There was no cooling in between injections and no cooling required after the single needle injections, but up to 90 minutes of cooling as needed.
Mean Change From Baseline in Average Daily Pain With Walking NPRS (0-10) Score by Subject Type	-3.48 score on a scale Standard Error 0.191	-3.52 score on a scale Standard Error 0.416	-4.02 score on a scale Standard Error 0.118	-3.72 score on a scale Standard Error 0.122	—

Adverse Events

Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) Day 1 Through Week 8/Early Termination

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Single Knee Injection (Non-Index Knee PJR/TJR) Day 1 Through Week 8/Early Termination

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) Day 1 Through Day 7

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) Day 7 Through Week 8/Early Termination

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Knee Injection (Unilateral Mod-Sev OA Knee Pain) Day 1 Through Week 8/Early Termination n=273 participants at risk Subjects with moderate to severe OA knee pain in the index knee and mild to no pain in the non-index knee; TEAEs presented for subjects in the Single Knee Injection groups represents TEAEs occurring from Day 1 through Week 8/Early Termination	Single Knee Injection (Non-Index Knee PJR/TJR) Day 1 Through Week 8/Early Termination n=52 participants at risk Single Knee Injection (Non-index Knee partial or total joint replacement) Data presented for subjects in the Single Knee Injection groups represents TEAEs occurring from Day 1 through Week 8/Early Termination	Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) Day 1 Through Day 7 n=523 participants at risk Subjects with moderate to severe knee OA pain in both the index and non-index knee; TEAEs presented for subjects in the Bilateral Knee Injection group only from Day 1 (index knee) through Day 7 (i.e., prior to them receiving the second intra-articular injection of CNTX-4975)	Bilateral Knee Injection (Bilateral Mod-Sev OA Knee Pain) Day 7 Through Week 8/Early Termination n=427 participants at risk Subjects with moderate to severe knee OA pain in both the index and non-index knee that received bilateral injections of CNTX-4975; TEAEs presented for subjects in the Bilateral Knee Injection group from Day 8 (i.e., after receiving the second injection of CNTX-4975 into the nonindex knee) to Week 8/Early Termination. Note: 96 subjects did not receive a second injection of CNTX-4975
Cardiac disorders Acute myocardial infarction	0.37% 1/273 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/52 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/523 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/427 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.
Cardiac disorders Atrial Fibrillation	0.00% 0/273 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/52 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/523 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.23% 1/427 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.
Infections and infestations Cellulitis	0.00% 0/273 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/52 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/523 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.23% 1/427 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.
Infections and infestations Staphylococcal Infection	0.00% 0/273 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/52 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/523 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.23% 1/427 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/273 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/52 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/523 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.23% 1/427 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.
Immune system disorders Hypersensitivity	0.00% 0/273 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/52 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.00% 0/523 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.	0.23% 1/427 • Adverse events were collected from Screening to the End of the Study (8 Weeks) Adverse events are reported here according to bilateral or unilateral injection group. Adverse events by injection group is of greater safety consequence and interest than events by cooling regimens because the injection group delineates exposures to CNTX-4975-05 (index knee only or bilateral intra-articular injections) while the cooling regimens does not. Therefore representing adverse events by injection group is a better indicator of safety in relation to study drug.

Other adverse events

Additional Information

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