A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain

• Sponsor: Centrexion Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03429049
• Collaborator: (none)
• Enrollment: 332
• Locations: 33
• Arms: 2
• Actual Duration (Months): 21.9
• Patients Per Site: 10.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the analgesic efficacy and safety of a single intra-articular (IA) CNTX-4975-05 (capsaicin), compared to IA placebo, in subjects with chronic, moderate-to-severe osteoarthritis (OA) knee pain.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Drug: CNTX-4975-05; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 332 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled, Single Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain
• Actual Study Start Date: Jan 24, 2018
• Actual Primary Completion Date: Nov 22, 2019
• Actual Study Completion Date: Nov 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Matching placebo of 2.0 mL for IA injection	Drug: Placebo; Receiving Placebo injection
Experimental: CNTX-4975-05 Pre-filled glass syringes administered as a single 2.0 mL IA injection	Drug: CNTX-4975-05; Receiving CNTX-4975-05 injection

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee [Baseline, Week 12]

   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.

Secondary Outcome Measures

1. Mean Change From Baseline in WOMAC A (Pain) Dimension Total Score [Baseline, Week 12]

   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.

2. Mean Change From Baseline WOMAC B (Stiffness) Dimension Total Score [Baseline, Week 12]

   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.

3. Mean Change From Baseline in WOMAC C (Physical Function) Dimension Total Score [Baseline, Week 12]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Male or female subjects between 40 and 95 years of age (inclusive) at the time of the Screening Visit with the ability to comply with answering the electronic diary using the study-provided tablet computers.

• Confirmation of osteoarthritis (OA) of the knee.

• Confirmation of OA of the index knee.

• Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.

• BMI ≤45 kg/m^2.

• Must have failed 2 or more prior therapies.

• Females not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile, or practicing one of the following medically acceptable methods of birth control throughout the study period.

• Subject agrees to stay on their current pain medication (including over the counter (OTC) medications) from the time of Screening through Week 12. The current pain medication must be taken only for pain in the index knee, and not for another pain indication.

• Subject agrees to take only the allowed rescue medications for OA knee pain of the index knee from the time of Screening through study completion and agrees to use no topical medications for OA knee pain during the trial.

Key Exclusion Criteria:

• Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months.

• Prior arthroscopic surgery of the index knee within 6 months of Screening.

• Any painful conditions of the index knee due to joint disease other than OA.

• Periarticular pain from any cause.

• Pain in the non-index knee that is >3 on a numeric pain rating scale (NPRS) (0-10) when walking or at rest.

• Other chronic pain anywhere in the body that requires the use of analgesic medications.

• Instability of the index knee.

• Misalignment (>10 degrees varus or valgus) of the index knee on standing.

• Documented history of neuropathic arthropathy or finding of bony fragmentation in the index knee with imaging.

• Physical/ occupational/ chiropractic therapy for the lower extremities or acupuncture for the lower extremities within 30 days of Screening, or need for such therapy during the study.

• Plans to have surgery, other invasive procedures, or IA injections while participating in the study.

• Has used topical capsaicin on the index knee within 90 days of Screening.

• Current use of opioids for any condition other than for OA of the index knee.

• Corticosteroid injection into the index knee within 90 days of Screening.

• Received IA viscosupplementation (eg, Synvisc®, Hyalgan®) within 90 days of Screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Orthopaedic Center - Research	Birmingham	Alabama	United States	35209
2	Cahaba Research, Inc	Birmingham	Alabama	United States	35242
3	Coastal Clinical Research, Inc	Mobile	Alabama	United States	36608
4	Noble Clinical Research, LLC	Tucson	Arizona	United States	85704
5	Orange County Research Institute	Anaheim	California	United States	92801
6	Core Healthcare Group	Cerritos	California	United States	90703
7	Biosolutions Clinical Research Center	La Mesa	California	United States	91942
8	Providence Clinical Research	North Hollywood	California	United States	91606
9	Medical Associates Research Group	San Diego	California	United States	92123
10	Encompass Clinical Research	Spring Valley	California	United States	91978
11	Tampa Bay Medical Research, Inc	Clearwater	Florida	United States	33761
12	Avail Clinical Research, LLC	DeLand	Florida	United States	32720
13	M&M Medical Center, Inc	Miami	Florida	United States	33185
14	Sensible Healthcare, LLC	Ocoee	Florida	United States	34761
15	Jewett Orthopaedic	Orlando	Florida	United States	32822
16	Clinical Research of West Florida, Inc.	Tampa	Florida	United States	33603
17	Drug Studies America	Marietta	Georgia	United States	30060
18	Georgia Institute for Clinical Research, LLC	Marietta	Georgia	United States	30060
19	Atlanta Orthopaedic Institute, LLC	Stockbridge	Georgia	United States	30281
20	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
21	Mid America PolyClinic	Overland Park	Kansas	United States	66210
22	Tufts Medical Center	Boston	Massachusetts	United States	02111
23	Tristan Medical Enterprises PC, dba	North Attleboro	Massachusetts	United States	02760
24	Medical Research Associates, Inc	Traverse City	Michigan	United States	49686
25	Sundance Clinical Research, LLC	Saint Louis	Missouri	United States	63141
26	Clinical Research Consortium	Las Vegas	Nevada	United States	89119
27	Hassman Research Institute	Berlin	New Jersey	United States	08009
28	Bone Joint & Spine Surgeons, Inc	Toledo	Ohio	United States	43623
29	Tekton Research, Inc	Austin	Texas	United States	78745
30	Metroplex Clinical Research Center	Dallas	Texas	United States	75231
31	Clinical Investigations of Texas	Plano	Texas	United States	75075
32	Ortho Virginia	Arlington	Virginia	United States	22205
33	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia	United States	22911

Sponsors and Collaborators

• Centrexion Therapeutics

Investigators

• Study Chair: Randall M. Stevens, MD, Centrexion Therapeutics

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 1, 2022

More Information

Publications

None provided.

• Responsible Party: Centrexion Therapeutics
• ClinicalTrials.gov Identifier: NCT03429049
• Other Study ID Numbers: CNTX-4975i-OA-301
• First Posted: Feb 12, 2018
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centrexion Therapeutics: analgesic; non-opioid; capsaicin; intra-articular; osteoarthritis; pain; knee pain
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

Participant Flow

Arm/Group Title	Placebo	CNTX-4975-05
Arm/Group Description	Matching placebo of 2.0 mL for IA injection	Pre-filled glass syringes administered as a single 2.0 mL IA injection
Period Title: Overall Study
STARTED	138	194
Treated	136	189
COMPLETED	110	152
NOT COMPLETED	28	42

Baseline Characteristics

Arm/Group Title	Placebo	CNTX-4975-05	Total
Arm/Group Description	Matching placebo of 2.0 mL for IA injection	Pre-filled glass syringes administered as a single 2.0 mL IA injection	Total of all reporting groups
Overall Participants	136	189	325
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61.8 (9.5)	61.8 (9.1)	61.8 (9.2)
Sex: Female, Male (Count of Participants)
Female	83 61%	123 65.1%	206 63.4%
Male	53 39%	66 34.9%	119 36.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	23 16.9%	37 19.6%	60 18.5%
Not Hispanic or Latino	113 83.1%	152 80.4%	265 81.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.7%	0 0%	1 0.3%
Asian	12 8.8%	15 7.9%	27 8.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	30 22.1%	46 24.3%	76 23.4%
White	90 66.2%	123 65.1%	213 65.5%
More than one race	0 0%	1 0.5%	1 0.3%
Unknown or Not Reported	3 2.2%	4 2.1%	7 2.2%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	32.07 (5.801)	31.55 (5.692)	31.77 (5.734)
Baseline Pain with Walking NPRS (0-10) Score (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	7.09 (1.152)	7.06 (1.082)	7.07 (1.110)
Baseline WOMAC A (Pain) Domain Score (range 0-50) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	30.80 (8.166)	31.92 (7.493)	31.45 (7.788)
Baseline WOMAC B (Stiffness) Domain Score (range 0-20) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	13.24 (3.389)	13.28 (3.232)	13.26 (3.293)
Baseline WOMAC C (Function) Domain Score (range 0-170) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	105.25 (29.755)	108.23 (27.085)	106.99 (28.222)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The intent to treat (ITT) population included all randomized subjects who received any amount of investigational product and all observed data.

Arm/Group Title	Placebo	CNTX-4975-05
Arm/Group Description	Matching placebo of 2.0 mL for IA injection	Pre-filled glass syringes administered as a single 2.0 mL IA injection
Measure Participants	130	177
Least Squares Mean (Standard Error) [score on a scale]	-2.84 (0.212)	-3.17 (0.182)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CNTX-4975-05
	Comments	The NRS least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1904
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.33
	Confidence Interval	(2-Sided) 95%; -0.84 to 0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.256
	Estimation Comments

2. Secondary Outcome

Title	Mean Change From Baseline in WOMAC A (Pain) Dimension Total Score
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The intent to treat (ITT) population included all randomized subjects who received any amount of investigational product and all observed data.

Arm/Group Title	Placebo	CNTX-4975-05
Arm/Group Description	Matching placebo of 2.0 mL for IA injection	Pre-filled glass syringes administered as a single 2.0 mL IA injection
Measure Participants	128	174
Least Squares Mean (Standard Error) [score on a scale]	-12.72 (1.002)	-15.42 (0.860)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CNTX-4975-05
	Comments	The WOMAC A least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0257
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.70
	Confidence Interval	(2-Sided) 95%; -5.07 to -0.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.206
	Estimation Comments

3. Secondary Outcome

Title	Mean Change From Baseline WOMAC B (Stiffness) Dimension Total Score
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The intent to treat (ITT) population included all randomized subjects who received any amount of investigational product and all observed data.

Arm/Group Title	Placebo	CNTX-4975-05
Arm/Group Description	Matching placebo of 2.0 mL for IA injection	Pre-filled glass syringes administered as a single 2.0 mL IA injection
Measure Participants	128	174
Least Squares Mean (Standard Error) [score on a scale]	-5.21 (0.448)	-6.15 (0.386)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CNTX-4975-05
	Comments	The WOMAC B least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0855
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.94
	Confidence Interval	(2-Sided) 95%; -2.01 to 0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.545
	Estimation Comments

4. Secondary Outcome

Title	Mean Change From Baseline in WOMAC C (Physical Function) Dimension Total Score
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

The intent to treat (ITT) population included all randomized subjects who received any amount of investigational product and all observed data.

Arm/Group Title	Placebo	CNTX-4975-05
Arm/Group Description	Matching placebo of 2.0 mL for IA injection	Pre-filled glass syringes administered as a single 2.0 mL IA injection
Measure Participants	128	174
Least Squares Mean (Standard Error) [score on a scale]	-42.70 (3.417)	-50.49 (2.935)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CNTX-4975-05
	Comments	The WOMAC C least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0550
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.80
	Confidence Interval	(2-Sided) 95%; -15.86 to 0.26
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.096
	Estimation Comments

Adverse Events

Time Frame	1 Year
Arm/Group Title	Placebo		CNTX-4975-05
Arm/Group Description	Matching placebo of 2.0 mL for IA injection		Pre-filled glass syringes administered as a single 2.0 mL IA injection
All Cause Mortality
	Placebo		CNTX-4975-05
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/136 (0%)		1/189 (0.5%)
Serious Adverse Events
	Placebo		CNTX-4975-05
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/136 (4.4%)		6/189 (3.2%)
Cardiac disorders
Supraventricular Tachycardia	0/136 (0%)	0	1/189 (0.5%)	1
Ear and labyrinth disorders
Vertigo Positional	1/136 (0.7%)	1	0/189 (0%)	0
General disorders
Chest Pain	1/136 (0.7%)	1	0/189 (0%)	0
Systemic inflammatory response	0/136 (0%)	0	1/189 (0.5%)	1
Infections and infestations
Appendicitis	0/136 (0%)	0	1/189 (0.5%)	1
Injury, poisoning and procedural complications
Acetabulum Fracture	0/136 (0%)	0	1/189 (0.5%)	1
Craniocerebral Injury	0/136 (0%)	0	1/189 (0.5%)	1
Foot Fracture	1/136 (0.7%)	1	0/189 (0%)	0
Hip Fracture	1/136 (0.7%)	1	0/189 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oestrogen receipt positive breast cancer	1/136 (0.7%)	1	0/189 (0%)	0
Prostate Cancer	1/136 (0.7%)	1	0/189 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure	0/136 (0%)	0	1/189 (0.5%)	1
Branchospasm	0/136 (0%)	0	1/189 (0.5%)	1
Pneumonitis	0/136 (0%)	0	1/189 (0.5%)	1
Surgical and medical procedures
Hip Arthroplasty	1/136 (0.7%)	1	0/189 (0%)	0
Vascular disorders
Hypotension	0/136 (0%)	0	1/189 (0.5%)	1
Peripheral Ischaemia	1/136 (0.7%)	1	0/189 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo		CNTX-4975-05
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/136 (33.1%)		110/189 (58.2%)
Gastrointestinal disorders
Nausea	2/136 (1.5%)	2	12/189 (6.3%)	12
General disorders
Injection site joint pain	1/136 (0.7%)	1	4/189 (2.1%)	4
Infections and infestations
Upper respiratory tract infection	7/136 (5.1%)	7	8/189 (4.2%)	8
Viral upper respiratory tract infection	3/136 (2.2%)	3	4/189 (2.1%)	4
Influenza	1/136 (0.7%)	1	5/189 (2.6%)	5
Urinary tract infection	3/136 (2.2%)	3	3/189 (1.6%)	3
Injury, poisoning and procedural complications
Procedural pain	2/136 (1.5%)	2	5/189 (2.6%)	5
Fall	2/136 (1.5%)	2	4/189 (2.1%)	4
Musculoskeletal and connective tissue disorders
Arthralgia	6/136 (4.4%)	6	19/189 (10.1%)	19
Osteoarthritis	3/136 (2.2%)	3	8/189 (4.2%)	8
Back pain	2/136 (1.5%)	2	5/189 (2.6%)	5
Joint effusion	1/136 (0.7%)	1	5/189 (2.6%)	5
Joint swelling	3/136 (2.2%)	3	3/189 (1.6%)	3
Joint stiffness	0/136 (0%)	0	4/189 (2.1%)	4
Nervous system disorders
Dizziness	3/136 (2.2%)	3	6/189 (3.2%)	6
Headache	1/136 (0.7%)	1	4/189 (2.1%)	4
Skin and subcutaneous tissue disorders
Hyperhidrosis	0/136 (0%)	0	6/189 (3.2%)	6
Surgical and medical procedures
Tooth extraction	3/136 (2.2%)	3	0/189 (0%)	0
Vascular disorders
Hypertension	2/136 (1.5%)	2	5/189 (2.6%)	5

Limitations/Caveats

[Not Specified]

More Information

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.