Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo of 2.0 mL for IA injection |
|
| CNTX-4975-05 | Experimental | Pre-filled glass syringes administered as a single 2.0 mL IA injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Receiving Placebo Injection |
| |
| CNTX-4975-05 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in WOMAC A (Pain) Dimension | 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee | 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. |
Not provided
Key Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Randall Stevens, MD | Centrexion Therapeutics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holland Center for Family Health | Glendale | Arizona | 85306 | United States | ||
| GB Family Care |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo of 2.0 mL for IA injection |
| FG001 | CNTX-4975-05 (Trans-capsaicin) | Pre-filled glass syringes administered as a single 2.0 mL IA injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Receiving CNTX-4975-05 Injection |
|
| Baseline, Week 12 |
| Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension | 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. | Baseline, Week 12 |
| Mean Change From Study Baseline in WOMAC C (Function) Dimension | 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. | Baseline, Week12 |
| Phoenix |
| Arizona |
| 85037 |
| United States |
| Arizona Research Center | Phoenix | Arizona | 85053 | United States |
| Med Center Medical Clinic | Carmichael | California | 95608 | United States |
| TriWest Research Associates | El Cajon | California | 92020 | United States |
| Arthritis Care and Research Center, Inc. (ACRC Studies) | Poway | California | 92064 | United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Panamerican Health Center, Inc. | Miami | Florida | 33126 | United States |
| Well Pharma Medical Research, Corp | Miami | Florida | 33143 | United States |
| Quality Research & Medical Center LLC | Miami | Florida | 33186 | United States |
| San Marcus Research Clinic, Inc. | Miami Lakes | Florida | 33014 | United States |
| Journey Research, Inc. | Oldsmar | Florida | 34677 | United States |
| M&M Clinical Trials Sunrise | Sunrise | Florida | 33351 | United States |
| Conquest Research | Winter Park | Florida | 32789 | United States |
| Better Health Clinical Research, Inc. | Newnan | Georgia | 30265 | United States |
| Healthcare Research Network, LLC | Flossmoor | Illinois | 60422 | United States |
| Affinity Clinical Research Institute | Oak Brook | Illinois | 60523 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | United States |
| BTC of New Bedford, LLC | New Bedford | Massachusetts | 02740 | United States |
| Healthcare Research Network | Hazelwood | Missouri | 63042 | United States |
| Office of Robert P. Kaplan, DO | Las Vegas | Nevada | 89119 | United States |
| Drug Trials America | Hartsdale | New York | 10530 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58104 | United States |
| Coastal Carolina Research Center at Arcis Healthcare, LLC dba Lowcountry Orthopaedics & Sports Medicine | North Charleston | South Carolina | 29406 | United States |
| Heartland Medical, PC | New Tazewell | Tennessee | 37825 | United States |
| First Surgical Hospital | Bellaire | Texas | 77401 | United States |
| Clinical Trials of Texas, Inc | San Antonio | Texas | 78229 | United States |
| DCT-Stone Oak, LLC dba Discovery Clinical Trials | San Antonio | Texas | 78258 | United States |
| Spectrum Medical, Inc. | Danville | Virginia | 24541 | United States |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population is defined as any subject that received any amount of investigational product
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo of 2.0 mL for IA injection |
| BG001 | CNTX-4975-05 (Trans-capsaicin) | Pre-filled glass syringes administered as a single 2.0 mL IA injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Study Baseline WOMAC A (Pain) Domain Score (range 0-50) | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions for knee or hip OA. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme).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. 0 being the best score and 50 being the worst. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Study Baseline WOMAC B (Stiffness) Domain Score (range 0-20) | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions for knee or hip OA. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme).The stiffness dimension includes 2 items about the joint stiffness upon wakening and joint stiffness later in the day. The score ranges from 0 to 20. 0 being the best score and 20 being the worst. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Study Baseline WOMAC C (Function) Domain Score (range 0-170) | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions for knee or hip OA. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme).The physical function dimension asks about the degree of difficulty in doing 17 activities due to the reference joint. The score ranges from 0 to 170. 0 being the best score and 170 being the worst. | Mean | Standard Deviation | score on a scale |
| ||||||||||||||
| Average Weekly Pain with Walking NPRS (0-10) Score | 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. | Mean | Standard Deviation | score on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in WOMAC A (Pain) Dimension | 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. | The intent to treat (ITT) population included all randomized subjects who received any amount of investigational product and all observed data | Posted | Least Squares Mean | Standard Deviation | score on a scale | Baseline, Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee | 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. | 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 | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension | 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. | The intent to treat (ITT) population included all randomized subjects who received any amount of investigational product and all observed data | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Study Baseline in WOMAC C (Function) Dimension | 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. | The intent to treat (ITT) population included all randomized subjects who received any amount of investigational product and all observed data | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week12 |
|
1 Year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo of 2.0 mL for IA injection | 0 | 140 | 9 | 140 | 34 | 140 |
| EG001 | CNTX-4975-05 (Trans-capsaicin) | Pre-filled glass syringes administered as a single 2.0 mL IA injection | 2 | 184 | 9 | 184 | 70 | 184 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MEDRA | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MEDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MEDRA | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MEDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MEDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MEDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MEDRA | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MEDRA | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDRA | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDRA | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MEDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MEDRA | Systematic Assessment |
| |
| Peritoneal abscess | Infections and infestations | MEDRA | Systematic Assessment |
| |
| Peritoneal bacterial | Infections and infestations | MEDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDRA | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MEDRA | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MEDRA | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MEDRA | Systematic Assessment |
| |
| Dislocation of vertebra | Injury, poisoning and procedural complications | MEDRA | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MEDRA | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MEDRA | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MEDRA | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MEDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MEDRA | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MEDRA | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MEDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | MEDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MEDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MEDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MEDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDRA | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MEDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MEDRA | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MEDRA | Systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MEDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MEDRA | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Centrexion Therapeutics, Inc. | 617-837-6911 | info@centrexion.com |
| Mar 16, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|