Axial SpondyloarthritisPhase 4NCT03582332
Serum Creatinine Change / Renal Adverse Effect With Use of Non-steroidal Painkillers in Axial Spondyloarthritis Patients
A Phase 4 study testing Indomethacin SR, 75 Mg Oral Capsule, Extended Release, Indomethacin 25 Mg Oral Capsule and Etoricoxib 90 mg in people with Axial Spondyloarthritis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Indomethacin SR, 75 Mg Oral Capsule, Extended Release, Indomethacin 25 Mg Oral Capsule and Etoricoxib 90 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2016to 23 Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- SpA (axial) patients according to Assessment of Spondyloarthritis International Society (ASAS) criteria with BASDAI > 4
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
Official title: Effect of Continuous Administration of Different Therapeutic Dosages of Indomethacin and Etoricoxib in the Management of Axial Spondyloarthritis: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- Indomethacin SR, 75 Mg Oral Capsule, Extended Release, Indomethacin 25 Mg Oral Capsule, Etoricoxib 90 mg, Etoricoxib 60 mg
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin SR, 75 Mg Oral Capsule, Extended ReleaseDrug
Also called indomethacin
Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily
Indomethacin 25 Mg Oral CapsuleDrug
Also called indomethacin
Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily
Etoricoxib 90 mgDrug
Also called Etoricoxib
Etoricoxib 90 mg once daily orally
Etoricoxib 60 mgDrug
Also called Etoricoxib
Etoricoxib 60 mg once daily orally
| Study group | Role | What they receive |
|---|---|---|
| Group A in phase 1 | Active comparator | Indomethacin 75 mg, extended release capsule twice daily Receives: Drug: Indomethacin SR, 75 Mg Oral Capsule, Extended Release |
| Group B in phase 1 | Active comparator | Indomethacin 25 mg capsule, 2 capsule twice daily Receives: Drug: Indomethacin 25 Mg Oral Capsule |
| Group A in phase 2 | Active comparator | Etoricoxib 90 mg once daily Receives: Drug: Etoricoxib 90 mg |
| Group B in phase 2 | Active comparator | Etoricoxib 60 mg once daily Receives: Drug: Etoricoxib 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine change
change in serum creatinine >25% from baseline with use of indomethacin and etoricoxib in Axial Spondyloarthritis patients
Measured: 3rd week and 24th week
Secondary outcomes (2)
Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI)
<4 responded to treatment, 4 or more means not responded to treatment
Measured: 3rd week and 24th week
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"
Measured: 3rd week and 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start2 Jan 2016
- Primary completion23 Jun 2016
- Study completion23 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khandker Mahbub-Uz-Zaman, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Khandker Mahbub-Uz-Zaman, MD, Principal investigator, Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582332
- Sponsor's protocol ID
- 2015/5965
- Status last verified
- Jul 2018
- First submitted
- 12 Mar 2018
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Administration of Different Therapeutic Dosages of Indomethacin and Etoricoxib in the Management of Axial Spondyloarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03582332
- Acronym / sponsor ID
- 2015/5965
- Conditions
- Axial Spondyloarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 23 Jun 2016 (actual)
- Study completion
- 23 Jun 2016 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A in phase 1 | Active comparator | Drug: Indomethacin SR, 75 Mg Oral Capsule, Extended ReleaseIndomethacin 75 mg, extended release capsule twice daily |
| Group B in phase 1 | Active comparator | Drug: Indomethacin 25 Mg Oral CapsuleIndomethacin 25 mg capsule, 2 capsule twice daily |
| Group A in phase 2 | Active comparator | Drug: Etoricoxib 90 mgEtoricoxib 90 mg once daily |
| Group B in phase 2 | Active comparator | Drug: Etoricoxib 60 mgEtoricoxib 60 mg once daily |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- SpA (axial) patients according to Assessment of Spondyloarthritis International Society (ASAS) criteria with BASDAI > 4
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indomethacin SR, 75 Mg Oral Capsule, Extended ReleaseAlso: indomethacinIndomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily | Drug | Group A in phase 1 |
| Indomethacin 25 Mg Oral CapsuleAlso: indomethacinIndomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily | Drug | Group B in phase 1 |
| Etoricoxib 90 mgAlso: EtoricoxibEtoricoxib 90 mg once daily orally | Drug | Group A in phase 2 |
| Etoricoxib 60 mgAlso: EtoricoxibEtoricoxib 60 mg once daily orally | Drug | Group B in phase 2 |
Primary outcome
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
2 secondary outcomes
Bath Ankyiosing Spodylitis Disease Activity Index (BASDAI)
Time frame: 3rd week and 24th week
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: 3rd week and 24th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khandker Mahbub-Uz-Zaman, MD principal investigator
Resident
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indomethacin SR, 75 Mg Oral Capsule, Extended Release, Indomethacin 25 Mg Oral Capsule and Etoricoxib 90 mg in people with Axial Spondyloarthritis, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum creatinine change (time frame: 3rd week and 24th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.