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Completed

NCT Number: NCT03582332

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indomethacin SR, 75 Mg Oral Capsule, Extended Release

Drug

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

Other names: indomethacin

Indomethacin 25 Mg Oral Capsule

Drug

Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily

Other names: indomethacin

Etoricoxib 90 mg

Drug

Etoricoxib 90 mg once daily orally

Other names: Etoricoxib

Etoricoxib 60 mg

Drug

Etoricoxib 60 mg once daily orally

Other names: Etoricoxib

Primary outcomes

  1. Serum creatinine change

    Time frame: 3rd week and 24th week

    change in serum creatinine >25% from baseline with use of indomethacin and etoricoxib in Axial Spondyloarthritis patients

Secondary outcomes

  1. Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI)

    Time frame: 3rd week and 24th week

    <4 responded to treatment, 4 or more means not responded to treatment

  2. Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Time frame: 3rd week and 24th week

    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"

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2018
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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