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

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.

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Drug: Loxoprofen sodium hydrogel patch; Drug: Loxoprofen sodium tablet

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Jieruo Gu, Prof, Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2015
• Primary Completion (Actual): December 10, 2015
• Study Completion (Actual): December 10, 2015

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: patch; ankylosing spondylitis; loxoprofen
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Loxoprofen
• Other Study ID Numbers: [2014]2-135

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No