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This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee.
Objectives of the study:
This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee.
After a screening period of up to 3 weeks and radiographic evaluation of the target knee joint space, 225 subjects will be randomly assigned to 1 of 3 treatment groups in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group (i.e., 2 subjects to active treatment and 1 subject to placebo):
Group A: low dose of X0002, twice daily (BID, approximately every 12 hours; n=50) or placebo (low dose), BID (approximately every 12 hours; n=25); Group B: middle dose of X0002, BID (approximately every 12 hours; n=50) or placebo , BID (approximately every 12 hours; n=25) ; Group C: High dose of X0002, BID (approximately every 12 hours; n=50) or placebo, BID (approximately every 12 hours; n=25) .
Safety and efficacy assessments will be performed at at 2, 4, 8, and 12 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| X0002 | Experimental | low dose, BID;middle dose, BID, or high dose, BID. |
|
| Placebo | Placebo Comparator | low dose, BID; middle dose, BID, or high dose, BID. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X0002 | Drug | Parallel Assignment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Efficacy of X0002 Spray Compared to Placebo for Relief of Knee Pain in Subjects With Osteoarthritis (OA) of the Knee | The Primary Efficacy Endpoint is change from Baseline in the WOMAC (VAS) pain subscale score for the target knee at 4 weeks of treatment, and will be analyzed using an analysis of covariance (ANCOVA). Treatment will be included as a fixed class effect and WOMAC Baseline pain subscale score as covariates. The primary comparisons of interest will be the difference between active Group A (low dose) and combined placebo, active Group B (middle dose) and combined placebo, and active Group C (high dose) and combined placebo. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | 4 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To Assess the Safety and Tolerability of Multiple Doses of X0002 When Administered as a Topical Spray | A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group. The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Global Assessment of Disease Status of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment | Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | at 2, 4, 8, and 12 weeks of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chongxi Yu, Ph.D. | Techfields Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fiel Family & Sports Medicine/Clinical Research Advantage Inc | Tempe | Arizona | 85283-1528 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Low dose of X0002/placebo, twice per day |
| FG001 | Group B | Middle dose of X0002/placebo, twice per day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Parallel Assignment |
|
|
| 2, 8, and 12 weeks of treatment |
| To Evaluate the Effect of X0002 Spray Compared to Placebo for the Relief of Joint Stiffness | A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group. The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 4, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | 2, 4, 8, and 12 weeks of treatment |
| To Assess the Effect of X0002 Spray Compared to Placebo on Difficulty Performing Daily Activities | A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group. The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | at 2, 4, 8, and 12 weeks of treatment |
| Characterize the Pharmacokinetics of X0002 | Cmax, Tmax, AUCs, apparent terminal elimination rate constant, apparent terminal elimination half-life will be calculated. | at the Week 2, week 3, week 4 and Week 12 |
| Investigator's Global Assessment of Disease Status of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment | Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | at 2, 4, 8, and 12 weeks of treatment |
| Subject's Global Assessment of Response to Therapy of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment | Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | at 2, 4, 8, and 12 weeks of treatment |
| Investigator's Global Assessment of Response to Therapy of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment | Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | at 2, 4, 8, and 12 weeks of treatment |
| Change From Baseline Over Time in VAS Pain Scores for the Target Knee From Daily Diary Data. | Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | at 2, 4, 8, and 12 weeks of treatment |
| Amount of Rescue Medication (Acetaminophen) Consumed Per Day for Target Knee Pain. | Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | at 2, 4, 8, and 12 weeks of treatment |
| Med Center |
| Carmichael |
| California |
| 95608 |
| United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| New England Research Assoc. | Trumbull | Connecticut | 06611 | United States |
| Clinical Research of South Florida | Coral Gables | Florida | 32720 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| Health Awareness Inc. | Jupiter | Florida | 33458 | United States |
| Suncoast Clinical Research, Inc | New Port Richey | Florida | 34652 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| Clinical Trials Technology(CTT) Consultants, Inc. | Prairie Village | Kansas | 66206-1362 | United States |
| Healthcare Research Network | Hazelwood | Missouri | 63042-1755 | United States |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141-7068 | United States |
| New Mexico Clinical Research & Osteoporosis Center, Inc. | Albuquerque | New Mexico | 87106 | United States |
| Hightop Medical Research | Cincinnati | Ohio | 45224 | United States |
| Prestige Clinical Research, LLC | Franklin | Ohio | 45005 | United States |
| Heritage Valley Medical Group | Beaver | Pennsylvania | 15009 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Quality Research Inc | San Antonio | Texas | 78209 | United States |
| Health Research of Hampton Roads, Inc | Newport News | Virginia | 23606 | United States |
| FG002 |
| Group C |
High dose of X0002/placebo, twice per day. |
| COMPLETED |
|
| NOT COMPLETED |
|
In the study, the active drug and placebo were mixed up and we did not have safety and efficacy data and no report at all.
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| ID | Title | Description |
|---|---|---|
| BG000 | X0002+Placebo | low dose, BID;middle dose, BID, or high dose, BID. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | In this study, the active drug and placebo were mixed up and we did not have safety and efficacy data and no report at all. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | In this study, the active drug and placebo were mixed up and we did not have safety and efficacy data and no report at all. | Count of Participants | Participants |
|
| 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 | To Evaluate the Efficacy of X0002 Spray Compared to Placebo for Relief of Knee Pain in Subjects With Osteoarthritis (OA) of the Knee | The Primary Efficacy Endpoint is change from Baseline in the WOMAC (VAS) pain subscale score for the target knee at 4 weeks of treatment, and will be analyzed using an analysis of covariance (ANCOVA). Treatment will be included as a fixed class effect and WOMAC Baseline pain subscale score as covariates. The primary comparisons of interest will be the difference between active Group A (low dose) and combined placebo, active Group B (middle dose) and combined placebo, and active Group C (high dose) and combined placebo. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | The labels for X0002 and placebo were mixed up, and the data was mixed up totally. | Posted | 4 weeks of treatment |
|
| |||||||||||||||||||||||
| Secondary | To Assess the Safety and Tolerability of Multiple Doses of X0002 When Administered as a Topical Spray | A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group. The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | The labels for X0002 and placebo were mixed up, and the data was mixed up totally. | Posted | 2, 8, and 12 weeks of treatment |
| ||||||||||||||||||||||||
| Secondary | To Evaluate the Effect of X0002 Spray Compared to Placebo for the Relief of Joint Stiffness | A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group. The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 4, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | The labels for X0002 and placebo were mixed up, and the data was mixed up totally. | Posted | 2, 4, 8, and 12 weeks of treatment |
| ||||||||||||||||||||||||
| Secondary | To Assess the Effect of X0002 Spray Compared to Placebo on Difficulty Performing Daily Activities | A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group. The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | The labels for X0002 and placebo were mixed up, and the data was mixed up totally. | Posted | at 2, 4, 8, and 12 weeks of treatment |
| ||||||||||||||||||||||||
| Secondary | Characterize the Pharmacokinetics of X0002 | Cmax, Tmax, AUCs, apparent terminal elimination rate constant, apparent terminal elimination half-life will be calculated. | The labels for X0002 and placebo were mixed up, and the data was mixed up totally. | Posted | at the Week 2, week 3, week 4 and Week 12 |
|
| |||||||||||||||||||||||
| Other Pre-specified | Subject's Global Assessment of Disease Status of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment | Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | The labels for X0002 and placebo were mixed up, and the data was mixed up totally. | Posted | at 2, 4, 8, and 12 weeks of treatment |
|
| |||||||||||||||||||||||
| Other Pre-specified | Investigator's Global Assessment of Disease Status of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment | Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | The labels for X0002 and placebo were mixed up, and the data was mixed up totally. | Posted | at 2, 4, 8, and 12 weeks of treatment |
|
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| Other Pre-specified | Subject's Global Assessment of Response to Therapy of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment | Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | The labels for X0002 and placebo were mixed up, and the data was mixed up totally. | Posted | at 2, 4, 8, and 12 weeks of treatment |
|
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| Other Pre-specified | Investigator's Global Assessment of Response to Therapy of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment | Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | The labels for X0002 and placebo were mixed up, and the data was mixed up totally. | Posted | at 2, 4, 8, and 12 weeks of treatment |
|
| |||||||||||||||||||||||
| Other Pre-specified | Change From Baseline Over Time in VAS Pain Scores for the Target Knee From Daily Diary Data. | Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | The labels for X0002 and placebo were mixed up, and the data was mixed up totally. | Posted | at 2, 4, 8, and 12 weeks of treatment |
|
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| Other Pre-specified | Amount of Rescue Medication (Acetaminophen) Consumed Per Day for Target Knee Pain. | Data for the exploratory efficacy endpoints will be summarized using descriptive statistics. Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned. | The labels for X0002 and placebo were mixed up, and the data was mixed up totally. | Posted | at 2, 4, 8, and 12 weeks of treatment |
|
|
This study was ongoing for about 16 weeks (12 weeks treatment, 1 week follow-up and 3 weeks screening). Safety assessments were performed at each visit and included assessment of AEs, vital signs (blood pressure, pulse rate, and oral temperature), clinical laboratories, physical examination, skin irritation, and electrocardiograms (ECGs).
In this study, the active drug and placebo were mixed up and we did not have safety and efficacy data and no report at all.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | X0002/Placebo | low dose, BID;middle dose, BID, or high dose, BID. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chongxi Yu | Techfields | 571 276 5371 | chongxiyu@hotmail.com |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000095485 | Bulk Drugs |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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