Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis

Sponsor

Sun Yat-sen University (Other)

Overall Status

Completed

CT.gov ID

NCT03800797

Collaborator

(none)

Enrollment

Location

Arms

6.5

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ankylosing Spondylitis	Drug: Loxoprofen sodium hydrogel patch Drug: Loxoprofen sodium tablet	Phase 4

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

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Loxoprofen Hydrogel Patch Versus Loxoprofen Tablet in Patients With Ankylosing Spondylitis: a 4-week Randomized, Open-label Study

Actual Study Start Date :

May 25, 2015

Actual Primary Completion Date :

Dec 10, 2015

Actual Study Completion Date :

Dec 10, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LX-P group loxoprofen sodium hydrogel patch (LX-P) 100 mg per day for 4 weeks	Drug: Loxoprofen sodium hydrogel patch 100 mg per day Other Names: Loxoprofen hydrogel patch
Active Comparator: LX-T group loxoprofen sodium tablet (LX-T) 60 mg t.i.d. for 4 weeks	Drug: Loxoprofen sodium tablet 60 mg t.i.d. Other Names: Loxoprofen tablet

Arm

Intervention/Treatment

Experimental: LX-P group

loxoprofen sodium hydrogel patch (LX-P) 100 mg per day for 4 weeks

Drug: Loxoprofen sodium hydrogel patch

100 mg per day

Other Names:

Loxoprofen hydrogel patch

Active Comparator: LX-T group

loxoprofen sodium tablet (LX-T) 60 mg t.i.d. for 4 weeks

Drug: Loxoprofen sodium tablet

60 mg t.i.d.

Other Names:

Loxoprofen tablet

Outcome Measures

Primary Outcome Measures

the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20) [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)

Secondary Outcome Measures

ASAS5/6 response [week 4]
defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)
ASAS20 response [week 2]
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)
ASAS5/6 response [week 2]
defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.