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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03800797
Recruitment Status : Completed
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Gu Jieruo, Sun Yat-sen University

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 10, 2015
Actual Study Completion Date : December 10, 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Loxoprofen tablet




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800797


Locations
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China, Guangdong
Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Director: Jieruo Gu, Prof Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
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Responsible Party: Gu Jieruo, Director, Department of Rheumatology, The Third Affiliated Hospital of Sun Yat-Sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03800797    
Other Study ID Numbers: [2014]2-135
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: December 2015

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gu Jieruo, Sun Yat-sen University:
ankylosing spondylitis
loxoprofen
patch
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Loxoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents