Ankylosing SpondylitisPhase 4NCT03800797
Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis
A Phase 4 study testing Loxoprofen sodium hydrogel patch and Loxoprofen sodium tablet in people with Ankylosing Spondylitis, run by Sun Yat-sen University at 1 site in China.
Trial summary
To assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Loxoprofen sodium hydrogel patch and Loxoprofen sodium tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2015to 10 Dec 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years
- Meet 1984 modified New York criteria for AS
- The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3
- NSAIDs washout period of at least 5 days prior to randomization
- DMARDs washout period of at least 4 weeks prior to randomization
- Corticosteroids washout period of at least 4 weeks prior to randomization
- Biological agents washout period of at least 3 months prior to randomization.
Who cannot join
- Peptic ulcer
- Unstable cardiac diseases
- Abnormal hepatic function with an elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 times of upper normal limits
- Abnormal renal function with creatinine more than upper normal limit
- Hematologic disorders
- Psychosis
- Malignancy
- Allergic to LX drug.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
About this study
Official title: Efficacy and Safety of Loxoprofen Hydrogel Patch Versus Loxoprofen Tablet in Patients With Ankylosing Spondylitis: a 4-week Randomized, Open-label Study
To assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.
Read the detailed description
This is a 4-week randomized, open-label trial to investigate the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Loxoprofen sodium hydrogel patch, Loxoprofen sodium tablet
- Keywords
- ankylosing spondylitis, loxoprofen, patch
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loxoprofen sodium hydrogel patchDrug
Also called Loxoprofen hydrogel patch
100 mg per day
Loxoprofen sodium tabletDrug
Also called Loxoprofen tablet
60 mg t.i.d.
| Study group | Role | What they receive |
|---|---|---|
| LX-P group | Experimental | loxoprofen sodium hydrogel patch (LX-P) 100 mg per day for 4 weeks Receives: Drug: Loxoprofen sodium hydrogel patch |
| LX-T group | Active comparator | loxoprofen sodium tablet (LX-T) 60 mg t.i.d. for 4 weeks Receives: Drug: Loxoprofen sodium tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20)
ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
Measured: week 4
Secondary outcomes (3)
ASAS5/6 response
defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)
Measured: week 4
ASAS20 response
ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
Measured: week 2
ASAS5/6 response
defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)
Measured: week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start25 May 2015
- Primary completion10 Dec 2015
- Study completion10 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gu Jieruo, Sun Yat-sen University
- Investigators
- Jieruo Gu, Prof, Study director, Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800797
- Sponsor's protocol ID
- [2014]2-135
- Status last verified
- Dec 2015
- First submitted
- 7 Jan 2019
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Loxoprofen Hydrogel Patch Versus Loxoprofen Tablet in Patients With Ankylosing Spondylitis: a 4-week Randomized, Open-label Study
- ClinicalTrials.gov ID
- NCT03800797
- Acronym / sponsor ID
- [2014]2-135
- Conditions
- Ankylosing Spondylitis
- Keywords
- ankylosing spondylitis, loxoprofen, patch
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 25 May 2015 (actual)
- Primary completion
- 10 Dec 2015 (actual)
- Study completion
- 10 Dec 2015 (actual)
- First posted
- 11 Jan 2019 (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.
To assess the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.
Detailed description
This is a 4-week randomized, open-label trial to investigate the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) versus loxoprofen sodium tablet (LX-T) in patients with active ankylosing spondylitis(AS). The trial includes 70 patients who are randomly assigned to either the LX-P group (LX-P 100 mg per day) or LX-T group (LX-T 60 mg t.i.d.) for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LX-P group | Experimental | Drug: Loxoprofen sodium hydrogel patchloxoprofen sodium hydrogel patch (LX-P) 100 mg per day for 4 weeks |
| LX-T group | Active comparator | Drug: Loxoprofen sodium tabletloxoprofen sodium tablet (LX-T) 60 mg t.i.d. for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 65 years
- Meet 1984 modified New York criteria for AS
- The Bath AS Disease Activity Index (BASDAI) ≥4 on a 0-10-cm visual analog scale or the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein level (ASDAS-CRP) ≥1.3
- NSAIDs washout period of at least 5 days prior to randomization
- DMARDs washout period of at least 4 weeks prior to randomization
Key exclusion criteria (8 listed)
- Peptic ulcer
- Unstable cardiac diseases
- Abnormal hepatic function with an elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 times of upper normal limits
- Abnormal renal function with creatinine more than upper normal limit
- Hematologic disorders
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 |
|---|---|---|
| Loxoprofen sodium hydrogel patchAlso: Loxoprofen hydrogel patch100 mg per day | Drug | LX-P group |
| Loxoprofen sodium tabletAlso: Loxoprofen tablet60 mg t.i.d. | Drug | LX-T group |
Primary outcome
the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20)
Time frame: week 4
ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI)
3 secondary outcomes
ASAS5/6 response
Time frame: week 4
ASAS20 response
Time frame: week 2
ASAS5/6 response
Time frame: week 2
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 Jan 2019.
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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.
Jieruo Gu, Prof study director
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Loxoprofen sodium hydrogel patch and Loxoprofen sodium tablet in people with Ankylosing Spondylitis, run by Sun Yat-sen University at 1 site in China.
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 7 inclusion and 8 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 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20) (time frame: week 4). 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 Jan 2019.