Trial · NCT00807846
A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
NCT00807846, Phase 4, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2015-11-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects. Trials, record NCT00807846. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00807846
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
- NCT number
- NCT00807846
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 201 participants, actual
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Conditions
- Arthritis, Juvenile Rheumatoid
- Interventions
- Celecoxib, Naproxen
- First posted
- 2008-12-12
- Last updated
- 2021-02-02
- Results first posted
- 2015-11-11
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Change From Baseline to Week 2 in SBP. | 2 weeks | Value at 2 weeks minus value at baseline. |
| Secondary | Change From Baseline in SBP at Week 4. | 4 weeks | Value at 4 weeks minus value at baseline. |
| Secondary | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. | 2 weeks | Value at 2 weeks minus value at baseline. |
| Secondary | Change From Baseline in DBP at Week 4. | 4 weeks | Value at 4 weeks minus value at baseline. |
| Secondary | Change From Baseline in DBP at Week 6/Final Visit | 6 weeks | Value at 6 weeks/Final Visit minus value at baseline. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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'. |
| Secondary | 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'. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit | 6 Weeks/Final Visit | 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. | mmHg (millimeter of mercury) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 2 in SBP. | 2 weeks | 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. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SBP at Week 4. | 4 weeks | 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. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. | 2 weeks | 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. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in DBP at Week 4. | 4 weeks | 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. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in DBP at Week 6/Final Visit | 6 weeks | 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. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit. | 6 weeks | 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. | mm (millimeter) | LEAST_SQUARES_MEAN |
| SECONDARY | 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 MITT Population included all randomized participants who received at least one dose of study medication and had at least one post-baseline efficacy measurement. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit. | 6 weeks | 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. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | 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. | Participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit | Celecoxib | 0.366 | Standard Error 0.70 | mmHg (millimeter of mercury) | |
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit | Naproxen | -0.734 | Standard Error 0.70 | mmHg (millimeter of mercury) | |
| Change From Baseline to Week 2 in SBP. | Celecoxib | -0.202 | Standard Error 0.53 | mmHg | |
| Change From Baseline to Week 2 in SBP. | Naproxen | -1.290 | Standard Error 0.53 | mmHg | |
| Change From Baseline in SBP at Week 4. | Celecoxib | -0.170 | Standard Error 0.58 | mmHg | |
| Change From Baseline in SBP at Week 4. | Naproxen | -2.007 | Standard Error 0.58 | mmHg | |
| Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. | Celecoxib | -1.346 | Standard Error 0.52 | mmHg | |
| Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. | Naproxen | -0.139 | Standard Error 0.52 | mmHg | |
| Change From Baseline in DBP at Week 4. | Celecoxib | -0.628 | Standard Error 0.54 | mmHg | |
| Change From Baseline in DBP at Week 4. | Naproxen | -0.848 | Standard Error 0.54 | mmHg |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Celecoxib | 100 | |
| Overall Study | STARTED | Naproxen | 98 | |
| Overall Study | COMPLETED | Celecoxib | 88 | |
| Overall Study | COMPLETED | Naproxen | 94 | |
| Overall Study | NOT COMPLETED | Celecoxib | 12 | |
| Overall Study | NOT COMPLETED | Naproxen | 4 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Celecoxib | 4 | 100 | |
| other | Nausea | Gastrointestinal disorders | Naproxen | 9 | 98 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Celecoxib | 1 | 100 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Naproxen | 5 | 98 | |
| other | Headache | Nervous system disorders | Celecoxib | 7 | 100 | |
| other | Headache | Nervous system disorders | Naproxen | 4 | 98 | |
| serious | Hand fracture | Injury, poisoning and procedural complications | Celecoxib | 0 | 100 | |
| serious | Hand fracture | Injury, poisoning and procedural complications | Naproxen | 1 | 98 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Celecoxib | ||
| Total, all-cause mortality | Naproxen | ||
| Total, other adverse events | Celecoxib | 10 | 100 |
| Total, other adverse events | Naproxen | 18 | 98 |
| Total, serious adverse events | Celecoxib | 0 | 100 |
| Total, serious adverse events | Naproxen | 1 | 98 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Celecoxib vs Naproxen: Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit. | Trial comparisons |
| Celecoxib vs Naproxen: Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit. | Trial comparisons |
| Celecoxib vs Naproxen: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00807846
GET https://conductscience.org/api/trials/v1/NCT00807846/results?page=2