Overview

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

Status:
Completed
Trial end date:
2016-06-23
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Treatments:
Etoricoxib
Indomethacin
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