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

Axial Spondyloarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582332
• Other study ID #: 2015/5965
• Status: Completed
• Phase: Phase 4
• Start date: January 2, 2016
• Est. completion date: June 23, 2016

Study information

• Verified date: July 2018
• Source: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 23, 2016
• Est. primary completion date: June 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis

Intervention

Drug:
• Indomethacin SR, 75 Mg Oral Capsule, Extended Release
Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily
• Indomethacin 25 Mg Oral Capsule
Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily
• Etoricoxib 90 mg
Etoricoxib 90 mg once daily orally
• Etoricoxib 60 mg
Etoricoxib 60 mg once daily orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI)	<4 responded to treatment, 4 or more means not responded to treatment	3rd week and 24th week
Secondary	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