Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis (NCT NCT02067611)
NCT ID: NCT02067611
Last Updated: 2018-02-07
Results Overview
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.
COMPLETED
PHASE2
216 participants
4 weeks of treatment
2018-02-07
Participant Flow
Participant milestones
| Measure |
Group A
Low dose of X0002/placebo, twice per day
|
Group B
Middle dose of X0002/placebo, twice per day.
|
Group C
High dose of X0002/placebo, twice per day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
72
|
72
|
72
|
|
Overall Study
COMPLETED
|
66
|
66
|
68
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 4 weeks of treatmentPopulation: The labels for X0002 and placebo were mixed up, and the data was mixed up totally.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2, 8, and 12 weeks of treatmentPopulation: The labels for X0002 and placebo were mixed up, and the data was mixed up totally.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2, 4, 8, and 12 weeks of treatmentPopulation: The labels for X0002 and placebo were mixed up, and the data was mixed up totally.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 2, 4, 8, and 12 weeks of treatmentPopulation: The labels for X0002 and placebo were mixed up, and the data was mixed up totally.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at the Week 2, week 3, week 4 and Week 12Population: The labels for X0002 and placebo were mixed up, and the data was mixed up totally.
Cmax, Tmax, AUCs, apparent terminal elimination rate constant, apparent terminal elimination half-life will be calculated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: at 2, 4, 8, and 12 weeks of treatmentPopulation: The labels for X0002 and placebo were mixed up, and the data was mixed up totally.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: at 2, 4, 8, and 12 weeks of treatmentPopulation: The labels for X0002 and placebo were mixed up, and the data was mixed up totally.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: at 2, 4, 8, and 12 weeks of treatmentPopulation: The labels for X0002 and placebo were mixed up, and the data was mixed up totally.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: at 2, 4, 8, and 12 weeks of treatmentPopulation: The labels for X0002 and placebo were mixed up, and the data was mixed up totally.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: at 2, 4, 8, and 12 weeks of treatmentPopulation: The labels for X0002 and placebo were mixed up, and the data was mixed up totally.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: at 2, 4, 8, and 12 weeks of treatmentPopulation: The labels for X0002 and placebo were mixed up, and the data was mixed up totally.
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.
Outcome measures
Outcome data not reported
Adverse Events
X0002/Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place