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

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03800797
• Other study ID #: [2014]2-135
• Status: Completed
• Phase: Phase 4
• Start date: May 25, 2015
• Est. completion date: December 10, 2015

Study information

• Verified date: December 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 10, 2015
• Est. primary completion date: December 10, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Loxoprofen sodium hydrogel patch
100 mg per day
• Loxoprofen sodium tablet
60 mg t.i.d.

Locations

Country	Name	City	State
China	Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	week 4
Secondary	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)	week 4
Secondary	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)	week 2
Secondary	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)	week 2