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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Completed; Phase 4

Conditions: Axial Spondyloarthritis

Treatments: Drug: Indomethacin SR, 75 Mg Oral Capsule, Extended Release; Drug: Indomethacin 25 Mg Oral Capsule; Drug: Etoricoxib 90 mg; Drug: Etoricoxib 60 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03582332

2015/5965

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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64 participants in 4 patient groups

Group A in phase 1

Active Comparator group

Description:

Indomethacin 75 mg, extended release capsule twice daily

Treatment:

Drug: Indomethacin SR, 75 Mg Oral Capsule, Extended Release

Group B in phase 1

Active Comparator group

Description:

Indomethacin 25 mg capsule, 2 capsule twice daily

Treatment:

Drug: Indomethacin 25 Mg Oral Capsule

Group A in phase 2

Active Comparator group

Description:

Etoricoxib 90 mg once daily

Treatment:

Drug: Etoricoxib 90 mg

Group B in phase 2

Active Comparator group

Description:

Etoricoxib 60 mg once daily

Treatment:

Drug: Etoricoxib 60 mg