A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain

• Sponsor: Centrexion Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03660943
• Collaborator: (none)
• Enrollment: 332
• Locations: 30
• Arms: 2
• Actual Duration (Months): 21.1
• Patients Per Site: 11.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, placebo-controlled, 2-injection, 52-week study to evaluate the efficacy and safety of intra-articular injections of CNTX-4975-05 in subjects with chronic, moderate-to-severe osteoarthritis knee pain.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Drug: Placebo; Drug: CNTX-4975-05	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, 2-Injection, 52-Week Study to Evaluate the Efficacy and Safety of Intra-articular Injections of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain
• Actual Study Start Date: Sep 9, 2018
• Actual Primary Completion Date: Jun 11, 2020
• Actual Study Completion Date: Jun 11, 2020

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. Mean Change From Baseline in WOMAC A (Pain) Dimension [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.

Secondary 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.

2. Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension [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 Study Baseline in WOMAC C (Function) Dimension [Baseline, Week12]

   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 the 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.

• Body Mass Index (BMI) ≤45 kg/m^2

• Must have failed 2 or more prior therapies.

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 the OA.

• Periarticular pain from any cause.

• 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	Holland Center for Family Health	Glendale	Arizona	United States	85306
2	GB Family Care	Phoenix	Arizona	United States	85037
3	Arizona Research Center	Phoenix	Arizona	United States	85053
4	Med Center Medical Clinic	Carmichael	California	United States	95608
5	TriWest Research Associates	El Cajon	California	United States	92020
6	Arthritis Care and Research Center, Inc. (ACRC Studies)	Poway	California	United States	92064
7	Chase Medical Research, LLC	Waterbury	Connecticut	United States	06708
8	San Marcus Research Clinic, Inc.	Miami Lakes	Florida	United States	33014
9	Panamerican Health Center, Inc.	Miami	Florida	United States	33126
10	Well Pharma Medical Research, Corp	Miami	Florida	United States	33143
11	Quality Research & Medical Center LLC	Miami	Florida	United States	33186
12	Journey Research, Inc.	Oldsmar	Florida	United States	34677
13	M&M Clinical Trials Sunrise	Sunrise	Florida	United States	33351
14	Conquest Research	Winter Park	Florida	United States	32789
15	Better Health Clinical Research, Inc.	Newnan	Georgia	United States	30265
16	Healthcare Research Network, LLC	Flossmoor	Illinois	United States	60422
17	Affinity Clinical Research Institute	Oak Brook	Illinois	United States	60523
18	DelRicht Research	New Orleans	Louisiana	United States	70115
19	The Center for Rheumatology and Bone Research	Wheaton	Maryland	United States	20902
20	BTC of New Bedford, LLC	New Bedford	Massachusetts	United States	02740
21	Healthcare Research Network	Hazelwood	Missouri	United States	63042
22	Office of Robert P. Kaplan, DO	Las Vegas	Nevada	United States	89119
23	Drug Trials America	Hartsdale	New York	United States	10530
24	Lillestol Research LLC	Fargo	North Dakota	United States	58104
25	Coastal Carolina Research Center at Arcis Healthcare, LLC dba Lowcountry Orthopaedics & Sports Medicine	North Charleston	South Carolina	United States	29406
26	Heartland Medical, PC	New Tazewell	Tennessee	United States	37825
27	First Surgical Hospital	Bellaire	Texas	United States	77401
28	Clinical Trials of Texas, Inc	San Antonio	Texas	United States	78229
29	DCT-Stone Oak, LLC dba Discovery Clinical Trials	San Antonio	Texas	United States	78258
30	Spectrum Medical, Inc.	Danville	Virginia	United States	24541

Sponsors and Collaborators

• Centrexion Therapeutics

Investigators

• Study Chair: Randall Stevens, MD, Centrexion Therapeutics

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 12, 2020

More Information

Publications

None provided.

• Responsible Party: Centrexion Therapeutics
• ClinicalTrials.gov Identifier: NCT03660943
• Other Study ID Numbers: CNTX-4975i-OA-304
• First Posted: Sep 7, 2018
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Centrexion Therapeutics: Osteoarthritis; Knee Pain
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

Participant Flow

Arm/Group Title	Placebo	CNTX-4975-05 (Trans-capsaicin)
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	145	187
Treated	140	184
COMPLETED	109	134
NOT COMPLETED	36	53

Baseline Characteristics

Arm/Group Title	Placebo	CNTX-4975-05 (Trans-capsaicin)	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	140	184	324
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.8 (8.59)	62.8 (8.80)	62.8 (8.70)
Sex: Female, Male (Count of Participants)
Female	84 60%	115 62.5%	199 61.4%
Male	56 40%	69 37.5%	125 38.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	37 26.4%	56 30.4%	93 28.7%
Not Hispanic or Latino	103 73.6%	128 69.6%	231 71.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 1.4%	2 1.1%	4 1.2%
Asian	2 1.4%	0 0%	2 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	37 26.4%	49 26.6%	86 26.5%
White	97 69.3%	131 71.2%	228 70.4%
More than one race	1 0.7%	0 0%	1 0.3%
Unknown or Not Reported	1 0.7%	2 1.1%	3 0.9%
Body Mass Index (kg/m^2) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	32.40 (5.265)	32.37 (5.895)	32.38 (5.623)
Study Baseline WOMAC A (Pain) Domain Score (range 0-50) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	31.3 (7.2)	31.6 (7.36)	31.5 (7.28)
Study Baseline WOMAC B (Stiffness) Domain Score (range 0-20) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	13.2 (3.41)	13.2 (3.15)	13.2 (3.26)
Study Baseline WOMAC C (Function) Domain Score (range 0-170) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	107.9 (26.71)	109.5 (25.89)	108.8 (26.22)
Average Weekly Pain with Walking NPRS (0-10) Score (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	6.933 (1.021)	7.013 (0.9950)	6.978 (1.0055)

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in WOMAC A (Pain) Dimension
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	125	164
Least Squares Mean (Standard Deviation) [score on a scale]	-14.13 (12.217)	-17.16 (12.266)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CNTX-4975-05
	Comments	The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0833
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.07
	Confidence Interval	(2-Sided) 95%; -4.42 to 0.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.192
	Estimation Comments

2. Secondary 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 as collected in the daily diary

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	170
Least Squares Mean (Standard Error) [score on a scale]	-2.99 (0.213)	-3.41 (0.197)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CNTX-4975-05
	Comments	The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.
	Type of Statistical Test	Superiority
	Comments	The number of NPRS subjects differed from the WOMAC outcomes because of differences in missing data.
Statistical Test of Hypothesis	p-Value	0.0935
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.42
	Confidence Interval	(2-Sided) 95%; -0.91 to 0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.251
	Estimation Comments

3. Secondary Outcome

Title	Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension
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	125	164
Least Squares Mean (Standard Error) [score on a scale]	-5.36 (0.434)	-6.58 (0.404)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CNTX-4975-05
	Comments	The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0163
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.22
	Confidence Interval	(2-Sided) 95%; -2.22 to -0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.506
	Estimation Comments

4. Secondary Outcome

Title	Mean Change From Study Baseline in WOMAC C (Function) Dimension
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, Week12

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	125	164
Least Squares Mean (Standard Error) [score on a scale]	-49.03 (3.541)	-57.02 (3.307)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CNTX-4975-05
	Comments	The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0509
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.99
	Confidence Interval	(2-Sided) 95%; -16.01 to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.076
	Estimation Comments

Adverse Events

Time Frame	1 Year
Arm/Group Title	Placebo		CNTX-4975-05 (Trans-capsaicin)
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 (Trans-capsaicin)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/140 (0%)		2/184 (1.1%)
Serious Adverse Events
	Placebo		CNTX-4975-05 (Trans-capsaicin)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/140 (6.4%)		9/184 (4.9%)
Cardiac disorders
Angina unstable	1/140 (0.7%)		0/184 (0%)
Cardiac arrest	0/140 (0%)		1/184 (0.5%)
Cardiac failure congestive	0/140 (0%)		1/184 (0.5%)
Coronary artery disease	1/140 (0.7%)		0/184 (0%)
Coronary artery occlusion	0/140 (0%)		1/184 (0.5%)
Gastrointestinal disorders
Diverticular perforation	1/140 (0.7%)		0/184 (0%)
Hepatobiliary disorders
Cholecystitis acute	1/140 (0.7%)		0/184 (0%)
Hepatic cirrhosis	0/140 (0%)		1/184 (0.5%)
Infections and infestations
Bronchitis	0/140 (0%)		1/184 (0.5%)
Diverticulitis	1/140 (0.7%)		0/184 (0%)
Peritoneal abscess	1/140 (0.7%)		0/184 (0%)
Peritoneal bacterial	0/140 (0%)		1/184 (0.5%)
Pneumonia	0/140 (0%)		1/184 (0.5%)
Injury, poisoning and procedural complications
Cervical vertebral fracture	1/140 (0.7%)		0/184 (0%)
Dislocation of vertebra	1/140 (0.7%)		0/184 (0%)
Hip fracture	0/140 (0%)		1/184 (0.5%)
Metabolism and nutrition disorders
Hyperkalaemia	0/140 (0%)		1/184 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma	1/140 (0.7%)		1/184 (0.5%)
Breast cancer	1/140 (0.7%)		0/184 (0%)
Metastases to liver	0/140 (0%)		1/184 (0.5%)
Pancreatic carcinoma	0/140 (0%)		1/184 (0.5%)
Psychiatric disorders
Confusional state	0/140 (0%)		1/184 (0.5%)
Panic attack	0/140 (0%)		1/184 (0.5%)
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	0/140 (0%)		2/184 (1.1%)
Emphysema	1/140 (0.7%)		0/184 (0%)
Pulmonary embolism	0/140 (0%)		1/184 (0.5%)
Vascular disorders
Aortic aneurysm	1/140 (0.7%)		0/184 (0%)
Deep vein thrombosis	0/140 (0%)		1/184 (0.5%)
Other (Not Including Serious) Adverse Events
	Placebo		CNTX-4975-05 (Trans-capsaicin)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/140 (24.3%)		70/184 (38%)
Blood and lymphatic system disorders
Anaemia	0/140 (0%)		4/184 (2.2%)
Gastrointestinal disorders
Nausea	1/140 (0.7%)		5/184 (2.7%)
Infections and infestations
Viral upper respiratory tract infection	5/140 (3.6%)		13/184 (7.1%)
Upper respiratory tract infection	6/140 (4.3%)		4/184 (2.2%)
Bronchitis	2/140 (1.4%)		6/184 (3.3%)
Sinusitis	3/140 (2.1%)		5/184 (2.7%)
Urinary tract infection	3/140 (2.1%)		4/184 (2.2%)
Injury, poisoning and procedural complications
Procedural dizziness	1/140 (0.7%)		7/184 (3.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/140 (0.7%)		10/184 (5.4%)
Back Pain	1/140 (0.7%)		4/184 (2.2%)
Pain in extremity	1/140 (0.7%)		4/184 (2.2%)
Musculoskeletal pain	4/140 (2.9%)		0/184 (0%)
Arthritis	3/140 (2.1%)		0/184 (0%)
Nervous system disorders
Headache	3/140 (2.1%)		4/184 (2.2%)

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.