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OpenTrials
Completed

NCT Number: NCT03800797

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

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Loxoprofen sodium hydrogel patch

Drug

100 mg per day

Other names: Loxoprofen hydrogel patch

Loxoprofen sodium tablet

Drug

60 mg t.i.d.

Other names: Loxoprofen tablet

Primary outcomes

  1. 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)

Secondary outcomes

  1. ASAS5/6 response

    Time frame: 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)

  2. ASAS20 response

    Time frame: 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)

  3. ASAS5/6 response

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 11, 2019
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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