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

Primary Purpose

Axial Spondyloarthritis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Indomethacin SR, 75 Mg Oral Capsule, Extended Release
Indomethacin 25 Mg Oral Capsule
Etoricoxib 90 mg
Etoricoxib 60 mg
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group A in phase 1

    Group B in phase 1

    Group A in phase 2

    Group B in phase 2

    Arm Description

    Indomethacin 75 mg, extended release capsule twice daily

    Indomethacin 25 mg capsule, 2 capsule twice daily

    Etoricoxib 90 mg once daily

    Etoricoxib 60 mg once daily

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI)
    <4 responded to treatment, 4 or more means not responded to treatment
    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"

    Full Information

    First Posted
    March 12, 2018
    Last Updated
    July 9, 2018
    Sponsor
    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03582332
    Brief Title
    Serum Creatinine Change / Renal Adverse Effect With Use of Non-steroidal Painkillers in Axial Spondyloarthritis Patients
    Official Title
    Effect of Continuous Administration of Different Therapeutic Dosages of Indomethacin and Etoricoxib in the Management of Axial Spondyloarthritis: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2, 2016 (Actual)
    Primary Completion Date
    June 23, 2016 (Actual)
    Study Completion Date
    June 23, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Axial Spondyloarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    64 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A in phase 1
    Arm Type
    Active Comparator
    Arm Description
    Indomethacin 75 mg, extended release capsule twice daily
    Arm Title
    Group B in phase 1
    Arm Type
    Active Comparator
    Arm Description
    Indomethacin 25 mg capsule, 2 capsule twice daily
    Arm Title
    Group A in phase 2
    Arm Type
    Active Comparator
    Arm Description
    Etoricoxib 90 mg once daily
    Arm Title
    Group B in phase 2
    Arm Type
    Active Comparator
    Arm Description
    Etoricoxib 60 mg once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Indomethacin SR, 75 Mg Oral Capsule, Extended Release
    Other Intervention Name(s)
    indomethacin
    Intervention Description
    Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    Indomethacin 25 Mg Oral Capsule
    Other Intervention Name(s)
    indomethacin
    Intervention Description
    Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    Etoricoxib 90 mg
    Other Intervention Name(s)
    Etoricoxib
    Intervention Description
    Etoricoxib 90 mg once daily orally
    Intervention Type
    Drug
    Intervention Name(s)
    Etoricoxib 60 mg
    Other Intervention Name(s)
    Etoricoxib
    Intervention Description
    Etoricoxib 60 mg once daily orally
    Primary Outcome Measure Information:
    Title
    Serum creatinine change
    Description
    change in serum creatinine >25% from baseline with use of indomethacin and etoricoxib in Axial Spondyloarthritis patients
    Time Frame
    3rd week and 24th week
    Secondary Outcome Measure Information:
    Title
    Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI)
    Description
    <4 responded to treatment, 4 or more means not responded to treatment
    Time Frame
    3rd week and 24th week
    Title
    Ankylosing Spondylitis Disease Activity Score (ASDAS)
    Description
    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"
    Time Frame
    3rd week and 24th week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Khandker Mahbub-Uz-Zaman, MD
    Organizational Affiliation
    Resident
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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