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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03582332
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Khandker Mahbub-Uz-Zaman, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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.

Condition or disease Intervention/treatment Phase
Axial Spondyloarthritis Drug: Indomethacin SR, 75 Mg Oral Capsule, Extended Release Drug: Indomethacin 25 Mg Oral Capsule Drug: Etoricoxib 90 mg Drug: Etoricoxib 60 mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Continuous Administration of Different Therapeutic Dosages of Indomethacin and Etoricoxib in the Management of Axial Spondyloarthritis: A Randomized Controlled Trial
Actual Study Start Date : January 2, 2016
Actual Primary Completion Date : June 23, 2016
Actual Study Completion Date : June 23, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Creatinine

Arm Intervention/treatment
Active Comparator: Group A in phase 1
Indomethacin 75 mg, extended release capsule twice daily
Drug: Indomethacin SR, 75 Mg Oral Capsule, Extended Release
Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily
Other Name: indomethacin

Active Comparator: Group B in phase 1
Indomethacin 25 mg capsule, 2 capsule twice daily
Drug: Indomethacin 25 Mg Oral Capsule
Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily
Other Name: indomethacin

Active Comparator: Group A in phase 2
Etoricoxib 90 mg once daily
Drug: Etoricoxib 90 mg
Etoricoxib 90 mg once daily orally
Other Name: Etoricoxib

Active Comparator: Group B in phase 2
Etoricoxib 60 mg once daily
Drug: Etoricoxib 60 mg
Etoricoxib 60 mg once daily orally
Other Name: Etoricoxib




Primary Outcome Measures :
  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 Outcome Measures :
  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"



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582332


Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Principal Investigator: Khandker Mahbub-Uz-Zaman, MD Resident
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Responsible Party: Khandker Mahbub-Uz-Zaman, Resident, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT03582332    
Other Study ID Numbers: 2015/5965
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Indomethacin
Etoricoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors