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

NCT ID: NCT03582332

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-02
• Study Completion Date: 2016-06-23

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.

Conditions

Axial Spondyloarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A in phase 1

Indomethacin 75 mg, extended release capsule twice daily

Group Type: ACTIVE_COMPARATOR

Indomethacin SR, 75 Mg Oral Capsule, Extended Release

Intervention Type: DRUG

Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily

Group B in phase 1

Indomethacin 25 mg capsule, 2 capsule twice daily

Group Type: ACTIVE_COMPARATOR

Indomethacin 25 Mg Oral Capsule

Intervention Type: DRUG

Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily

Group A in phase 2

Etoricoxib 90 mg once daily

Group Type: ACTIVE_COMPARATOR

Etoricoxib 90 mg

Intervention Type: DRUG

Etoricoxib 90 mg once daily orally

Group B in phase 2

Etoricoxib 60 mg once daily

Group Type: ACTIVE_COMPARATOR

Etoricoxib 60 mg

Intervention Type: DRUG

Etoricoxib 60 mg once daily orally

Interventions

Indomethacin SR, 75 Mg Oral Capsule, Extended Release

Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily

Intervention Type: DRUG

Indomethacin 25 Mg Oral Capsule

Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily

Intervention Type: DRUG

Etoricoxib 90 mg

Etoricoxib 90 mg once daily orally

Intervention Type: DRUG

Etoricoxib 60 mg

Etoricoxib 60 mg once daily orally

Intervention Type: DRUG

Other Intervention Names

indomethacin; indomethacin; Etoricoxib; Etoricoxib

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Khandker Mahbub-Uz-Zaman

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khandker Mahbub-Uz-Zaman, MD

Role: PRINCIPAL_INVESTIGATOR

Resident

Other Identifiers

2015/5965

Identifier Type: -

Identifier Source: org_study_id