Arthritis, Juvenile Rheumatoid
Conditions
Keywords
Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis
Brief summary
This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis
Interventions
DRUGCelecoxib
Celecoxib 50 mg or 100 mg PO BID for 6 weeks
DRUGNaproxen
Naproxen 7.5 mg/kg PO BID \[maximum of 500 mg BID\] for 6 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for Juvenile Idiopathic Arthritis (JIA) * Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible * ≥2 years of age and \<18 years of age prior to the Baseline visit * Body weight ≥10 kg at the Baseline visit * Candidate for chronic NSAID therapy in the Investigator's judgment
Exclusion criteria
* Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA * Active systemic features over the prior 12 weeks in children with systemic Juvenile Idiopathic Arthritis (JIA) * Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded * Subjects with active Systemic JIA should not be enrolled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit | 6 Weeks/Final Visit | Value at 6 weeks minus value at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in DBP at Week 4. | 4 weeks | Value at 4 weeks minus value at baseline. |
| Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit. | 6 weeks | The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor. |
| Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit. | Week 6/Final Visit | The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor. |
| Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit. | 6 weeks | Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'. |
| Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit. | Week 6/Final Visit | Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'. |
| Change From Baseline to Week 2 in SBP. | 2 weeks | Value at 2 weeks minus value at baseline. |
| Change From Baseline in SBP at Week 4. | 4 weeks | Value at 4 weeks minus value at baseline. |
| Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. | 2 weeks | Value at 2 weeks minus value at baseline. |
| Change From Baseline in DBP at Week 6/Final Visit | 6 weeks | Value at 6 weeks/Final Visit minus value at baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant) | 6 weeks/Final Visit | A summary of ABPM 24-hour averages for SBP and DBP are presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002). |
| Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant) | 6 weeks/Final Visit | A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002). |
| Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit | 6 weeks/Final Visit | Ambulatory BP measurements were obtained from 24 participants (in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. |
| Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit | 6 weeks/Final Visit | Ambulatory BP measurements were obtained from 24 participants(in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. BP was monitored by a 24 hour Ambulatory BP device provided by a central vendor. |
Countries
Chile, Costa Rica, Peru, Philippines, Russia, Serbia, South Africa, Switzerland, Ukraine, United States
Participant flow
Recruitment details
This was a phase 4, 6-week, randomized double-blind, multicenter, active-controlled trial in participants with juvenile idiopathic arthritis (JIA). A total of 221 participants were screened into the study in 32 investigator sites.
Pre-assignment details
A total of 101 participants were randomized to treatment with Celecoxib and 100 participants to treatment with Naproxen. Of these randomized, 100 participants received treatment with Celecoxib and 98 participants received treatment with Naproxen. Three participants were randomized but did not receive any treatment.
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit | 100 |
| Naproxen Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject's weight at Baseline visit | 98 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 0 |
| Overall Study | Lack of Efficacy | 2 | 0 |
| Overall Study | Other | 1 | 2 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Naproxen | Celecoxib |
|---|---|---|---|
| Age, Customized >=13 - <18 Years | 77 Participants | 33 Participants | 44 Participants |
| Age, Customized >=2 - <8 Years | 40 Participants | 18 Participants | 22 Participants |
| Age, Customized >=8 - <13 Years | 81 Participants | 47 Participants | 34 Participants |
| Sex: Female, Male Female | 140 Participants | 64 Participants | 76 Participants |
| Sex: Female, Male Male | 58 Participants | 34 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 100 | 18 / 98 |
| serious Total, serious adverse events | 0 / 100 | 1 / 98 |
Outcome results
Primary
Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
Value at 6 weeks minus value at baseline.
Time frame: 6 Weeks/Final Visit
Population: Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP (blood pressure) measurements.~For early terminations the last observation carried forward (LOCF) was used to impute missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit | 0.366 mmHg (millimeter of mercury) | Standard Error 0.7 |
| Naproxen | Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit | -0.734 mmHg (millimeter of mercury) | Standard Error 0.7 |
Comparison: The primary analysis was based on 90% confidence interval (CI) for the difference across treatment groups (celecoxib - naproxen) in mean change from baseline in SBP. Change from Baseline in BP was analyzed using analysis of covariance (ANCOVA) with model terms for treatment with baseline height, baseline weight, baseline age, and baseline SBP as covariates. No formal hypothesis testing was applied to the primary analysis.p-value: 0.27490% CI: [-0.56, 2.76]ANCOVA
Secondary
Change From Baseline in DBP at Week 4.
Value at 4 weeks minus value at baseline.
Time frame: 4 weeks
Population: Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline in DBP at Week 4. | -0.628 mmHg | Standard Error 0.54 |
| Naproxen | Change From Baseline in DBP at Week 4. | -0.848 mmHg | Standard Error 0.54 |
Comparison: For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.p-value: 0.77695% CI: [-1.3, 1.74]ANCOVA
Secondary
Change From Baseline in DBP at Week 6/Final Visit
Value at 6 weeks/Final Visit minus value at baseline.
Time frame: 6 weeks
Population: Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline in DBP at Week 6/Final Visit | -0.535 mmHg | Standard Error 0.54 |
| Naproxen | Change From Baseline in DBP at Week 6/Final Visit | -0.356 mmHg | Standard Error 0.54 |
Comparison: For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline blood pressure as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.p-value: 0.81595% CI: [-1.69, 1.33]ANCOVA
Secondary
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.
Value at 2 weeks minus value at baseline.
Time frame: 2 weeks
Population: Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. | -1.346 mmHg | Standard Error 0.52 |
| Naproxen | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. | -0.139 mmHg | Standard Error 0.52 |
Comparison: For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.p-value: 0.10695% CI: [-2.67, 0.26]ANCOVA
Secondary
Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.
The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.
Time frame: 6 weeks
Population: Modified-Intent-to-Treat (MITT) Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit. | -10.581 mm (millimeter) | Standard Error 2.081 |
| Naproxen | Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit. | -13.614 mm (millimeter) | Standard Error 2.06 |
Comparison: Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.p-value: 0.30395% CI: [-2.76, 8.82]ANCOVA
Secondary
Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.
Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.
Time frame: 6 weeks
Population: MITT population was used. Additional 3 participants aged \<8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (\>=8 yrs) not provided self-assessment and 2 (\>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (\<8 yrs) provided self-assessment and included in analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit. | -12.990 mm | Standard Error 2.226 |
| Naproxen | Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit. | -12.588 mm | Standard Error 2.115 |
Comparison: Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.p-value: 0.89795% CI: [-6.5, 5.69]ANCOVA
Secondary
Change From Baseline in SBP at Week 4.
Value at 4 weeks minus value at baseline.
Time frame: 4 weeks
Population: Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline in SBP at Week 4. | -0.170 mmHg | Standard Error 0.58 |
| Naproxen | Change From Baseline in SBP at Week 4. | -2.007 mmHg | Standard Error 0.58 |
Comparison: For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in blood pressure was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates.~Secondary analyses were conducted using a two-sided test with α=0.05.p-value: 0.02795% CI: [0.21, 3.46]ANCOVA
Secondary
Change From Baseline to Week 2 in SBP.
Value at 2 weeks minus value at baseline.
Time frame: 2 weeks
Population: Safety population included all randomized participants who received at least one dose of study medication. The Safety Analysis set was used to analyze all BP measurements.~For early terminations the LOCF was used to impute missing data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline to Week 2 in SBP. | -0.202 mmHg | Standard Error 0.53 |
| Naproxen | Change From Baseline to Week 2 in SBP. | -1.290 mmHg | Standard Error 0.53 |
Comparison: For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.p-value: 0.14895% CI: [-0.39, 2.57]ANCOVA
Secondary
Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.
The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.
Time frame: Week 6/Final Visit
Population: The MITT Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib | Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit. | 47 Participants |
| Naproxen | Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit. | 54 Participants |
Comparison: The number of subjects with at least a 30% improvement in Parent/Guardian's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.p-value: 0.39295% CI: [-0.202, 0.079]Chi-squared
Secondary
Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.
Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.
Time frame: Week 6/Final Visit
Population: MITT population was used. Additional 3 participants aged \<8 yrs at Baseline in Naproxen Arm provided self-assessments. In Celecoxib Arm, 2 participants (\>=8 yrs) not provided self-assessment and 2 (\>=8 yrs) provided but they were not from MITT and were excluded; additional 1 participant (\<8 yrs) provided self-assessment and included in analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Celecoxib | Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit. | 33 Participants |
| Naproxen | Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit. | 45 Participants |
Comparison: The number of participants with at least a 30% improvement in participant's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.p-value: 0.295% CI: [-0.257, 0.053]Chi-squared
Other Pre-specified
Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit
Ambulatory BP measurements were obtained from 24 participants (in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure.
Time frame: 6 weeks/Final Visit
Population: Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit | 2.5 bpm (beats per minute) | Standard Deviation 6.34 |
| Naproxen | Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit | 3.7 bpm (beats per minute) | Standard Deviation 8.5 |
Other Pre-specified
Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)
A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).
Time frame: 6 weeks/Final Visit
Population: Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib | Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant) | 2.5 bpm | Standard Deviation 6.34 |
| Naproxen | Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant) | 3.3 bpm | Standard Deviation 8.82 |
Other Pre-specified
Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)
A summary of ABPM 24-hour averages for SBP and DBP are presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002).
Time frame: 6 weeks/Final Visit
Population: Safety population included all randomized participants who received at least one dose of study medication. A total of 22 out of 24 participants were analyzed in this sensitivity analysis. Two participants were excluded, one due to outlying BP values at Baseline and another due to the device failure to collect 11 out of 24 readings).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant) | SBP | 2.4 mmHg | Standard Deviation 7.02 |
| Celecoxib | Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant) | DBP | 0.9 mmHg | Standard Deviation 4.23 |
| Naproxen | Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant) | SBP | 1.9 mmHg | Standard Deviation 4.13 |
| Naproxen | Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant) | DBP | 0.3 mmHg | Standard Deviation 2.86 |
Other Pre-specified
Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit
Ambulatory BP measurements were obtained from 24 participants(in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. BP was monitored by a 24 hour Ambulatory BP device provided by a central vendor.
Time frame: 6 weeks/Final Visit
Population: Safety population included all randomized participants who received at least one dose of study medication. For one participant in Naproxen Arm the device failed to collect 11 out of 24 readings at Week 6 and this participant was not included in analysis. ABPM data were analyzed for 12 and 11 participants in Celecoxib and Naproxen Arms respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Celecoxib | Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit | SBP | 2.4 mmHg | Standard Deviation 7.02 |
| Celecoxib | Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit | DBP | 0.9 mmHg | Standard Deviation 4.23 |
| Naproxen | Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit | SBP | -1.7 mmHg | Standard Deviation 12.4 |
| Naproxen | Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit | DBP | -1.1 mmHg | Standard Deviation 5.36 |