Serum Creatinine Change / Renal Adverse Effect With Use of Non-steroidal Painkillers in Axial Spondyloarthritis Patients

Study Overview
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Brief Summary
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2 Non-steroidal anti-inflammatory drugs (NSAIDs), indomethacin and etoricoxib were prescribed sequentially in Axial Spondyloarthritis patients according to the internationally accepted guidelines to determine serum creatinine change with NSAIDs use.

Detailed Description
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The study had 2 phases. In phase 1, Patients of axial Spondyloarthritis were randomized into 2 groups; group A and group B. they were put on indomethacin 150 mg/day and indomethacin 100 mg/day respectively and were followed up at 3rd week. Those who had normal serum creatinine and responded with the drug were followed up to 24th week. Those who did not respond were excluded from phase 1 and were enrolled in phase 2. Non-responders of indomethacin 150mg and indomethacin 100 mg were put on etoricoxib 90 mg and etoricoxib 60 mg respectively. Again followed up to 24th week.

Official Title
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Effect of Continuous Administration of Different Therapeutic Dosages of Indomethacin and Etoricoxib in the Management of Axial Spondyloarthritis: A Randomized Controlled Trial

Conditions
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Axial Spondyloarthritis

Intervention / Treatment
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* Drug: Indomethacin SR, 75 Mg Oral Capsule, Extended Release
* Drug: Indomethacin 25 Mg Oral Capsule
* Drug: Etoricoxib 90 mg
* Drug: Etoricoxib 60 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SpA (axial) patients according to Assessment of Spondyloarthritis International Society (ASAS) criteria with BASDAI > 4 Exclusion Criteria: Inadequate response to therapeutic dose of indomethacin or etoricoxib, taken for at least 2 weeks continuously Abnormal serum creatinine : serum creatinine >1.3 mg/dl Abnormal SGPT: SGPT > 40 U/L Hypertension: Systolic blood pressure > 140 mm Hg and/ or diastolic blood pressure >90 mm Hg or on anti-hypertensive drug Dyspepsia or active peptic ulcer disease : upper abdominal discomfort or upper abdominal pain related with food or peptic ulcer disease diagnosed by upper gastrointestinal endoscopy Diabetes mellitus: abnormal random plasma glucose or diagnosed case of diabetes mellitus Ischemic heart disease: history of angina or ECG changes suggestive of ischemic heart disease Active congestive heart failure: pedal edema with tender hepatomegaly with raised JVP or diastolic dysfunction on echocardiography Asthma: diagnosed case of asthma or rhonchi on chest auscultation Bleeding problems: having a history of prolonged bleeding Pregnancy: missed period followed by positive pregnancy test Simultaneous use with certain medications such as warfarin, phenytoin, cyclosporine, probenecid, lithium, digoxin, ACE inhibitor, thiazide

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A in phase 1<br>Indomethacin 75 mg, extended release capsule twice daily | Drug: Indomethacin SR, 75 Mg Oral Capsule, Extended Release<br>* Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily<br>* Other names: indomethacin;|
| Active Comparator: Group B in phase 1<br>Indomethacin 25 mg capsule, 2 capsule twice daily | Drug: Indomethacin 25 Mg Oral Capsule<br>* Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily<br>* Other names: indomethacin;|
| Active Comparator: Group A in phase 2<br>Etoricoxib 90 mg once daily | Drug: Etoricoxib 90 mg<br>* Etoricoxib 90 mg once daily orally<br>* Other names: Etoricoxib;|
| Active Comparator: Group B in phase 2<br>Etoricoxib 60 mg once daily | Drug: Etoricoxib 60 mg<br>* Etoricoxib 60 mg once daily orally<br>* Other names: Etoricoxib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum creatinine change | change in serum creatinine >25% from baseline with use of indomethacin and etoricoxib in Axial Spondyloarthritis patients | 3rd week and 24th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI) | <4 responded to treatment, 4 or more means not responded to treatment | 3rd week and 24th week | 
| Ankylosing Spondylitis Disease Activity Score (ASDAS) | ASDAS: <1.3 between inactive disease and moderate disease activity, <2.1 between moderate disease activity and high disease activity, and >3.5 between high disease activity and very high disease activity | 3rd week and 24th week |