A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
- Conditions
- -M08M08
- Registration Number
- PER-125-09
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 10
• Polyarticular AU (both positive rheumatoid factor and negative rheumatoid factor), oligoarticular and oligoarticular extended for> 3 months that meets the criteria of the International League of Associations for Rheumatology (ILAR) for AU [See Appendix 1, ILAR Criteria for AU]. Participants with Systemic AU with active arthritis in at least 1 joint but without active systemic characteristics are eligible. Participants with psoriatic arthritis, arthritis related to enteritis and undifferentiated arthritis should be excluded (See Exclusion Criteria I). Participants with active Systemic AU should not be enrolled. (See Exclusion Criteria 2);
•> 2 years of age and <18 years of age before the baseline visit;
• Body weight> 10 kg at baseline visit;
• Candidate for chronic therapy with NSAIDs in the opinion of the Researcher,
• Potentially fertile female participants (defined as menarche or> 10 years of age, whichever occurs first) must agree to use appropriate contraception (adequate contraception may include abstinence if the Investigator considers it appropriate) and must have a negative pregnancy test in urine before administration of the study drug;
• The participant´s parent or legal guardian has provided the written informed consent document prior to enrollment in this study.
• Psoriatic arthritis, arthritis related to enthesitis and undifferentiated arthritis types of JIA;
• Systemic characteristics active during the previous 12 weeks in children with systemic JIA;
• Participants taking any of the following iamiacs are specifically excluded: NSAIDs or current salicylate compounds, Anticoagulants, Lithium, Cyclosporine, Tacrolimus, Antihypertensives, Any drug that in the opinion of the researcher will affect blood pressure, Any investigational drug within the 30 days prior to the Selection or the participant is scheduled to receive a research drug during the course of this study.
• Start of or change in doses of disease-modifying antirheumatic drugs (DMARD) and / or Biological Products within 30 days of Selection;
• Oral or injectable corticosteroids (including intra-articular) administered within 2 weeks of Selection / Baseline. Participants are allowed to continue using intranasal or oral inhaled corticosteroids as long as they have been at a stable dose for at least 30 days before Selection / Baseline and whose dose is not expected to change during the study:
• Known hypersensitivity (allergy) or hypersensitivity to sulfonamides, selective COX-2 inhibitors (including celecoxib), aspirin or NSAIDs (including naproxen). Participants who have experienced asthma, hives or allergic reactions after taking aspirin or other NSAIDs should be excluded;
• Diagnosis of or treatment received for esophageal, gastric ulceration of the pyloric or duodenal canal within 60 days of Selection;
• Active GI disease (for example, inflammatory bowel disease, Crohn´s disease, ulcerative colitis), a chronic or acute renal or hepatic disorder, a significant coagulation defect, or any condition that in the opinion of the Investigator could prevent the use of an NSAID;
• AST (SGOT), ALT (SGPT), Creatinine or BUN> 1.5 x ULN for normal values adjusted for age / sex according to the central laboratory, or any other laboratory abnormality considered by the Researcher as clinically significant within 14 days before the Basal;
• Hypertension defined as PAS and / or PAD values> 95 percentile for the age, sex and height of the participant (according to the Fourth Report on Diagnosis, Evaluation and Treatment of Arterial Hypertension in Adolescents and Children 10, (See Appendix 2, Appendix 3 and Appendix 4) for 3 measurements at the Baseline visit If the participant´s medical history indicates that the participant is normotensive Participants can be re-selected during the 2-week Selection period to determine if the participant is suitable for the study Participants who are currently treated with antihypertensive drug (s) are not eligible for the study;
• Active malignancy or any type of history of a malignancy. (Participants with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and have no evidence of recurrence in the previous 2 years and at the time of Selection are acceptable);
• Any significant, uncontrolled chronic condition (for example, diabetes, epilepsy, psychiatric disorders) or any other condition that, in the opinion of the Researcher, could contraindicate participation in the study or confuse the interpretation of the results;
• Plans for surgical intervention during the course of the study;
• Have previously participated in this study;
• Little chance of complying with the study procedures, includin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Value at 6 weeks minus value at baseline.<br><br>Measure:Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit<br>Timepoints:6 Weeks/Final Visit<br>
- Secondary Outcome Measures
Name Time Method