Clinical trial NCT03582332: Serum Creatinine Change / Renal Adverse Effect With Use of Non-steroidal Painkillers in Axial Spondyloarthritis Patients
Official title: Effect of Continuous Administration of Different Therapeutic Dosages of Indomethacin and Etoricoxib in the Management of Axial Spondyloarthritis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Axial Spondyloarthritis
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum creatinine change
timeFrame: 3rd week and 24th week
Secondary outcomes:
measure: Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI)
timeFrame: 3rd week and 24th week
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: 3rd week and 24th week
Other outcomes:
Locations:
Study officials:
affiliation: Resident
name: Khandker Mahbub-Uz-Zaman, MD
role: PRINCIPAL_INVESTIGATOR
References: