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

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Loxoprofen sodium hydrogel patch
Loxoprofen sodium tablet
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ankylosing spondylitis, loxoprofen, patch

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LX-P group

LX-T group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)

Full Information

First Posted
January 7, 2019
Last Updated
January 10, 2019
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03800797
Brief Title
Efficacy and Safety of Loxoprofen Hydrogel Patch in Patients With Ankylosing Spondylitis
Official Title
Efficacy and Safety of Loxoprofen Hydrogel Patch Versus Loxoprofen Tablet in Patients With Ankylosing Spondylitis: a 4-week Randomized, Open-label Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 25, 2015 (Actual)
Primary Completion Date
December 10, 2015 (Actual)
Study Completion Date
December 10, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
ankylosing spondylitis, loxoprofen, patch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LX-P group
Arm Type
Experimental
Arm Description
loxoprofen sodium hydrogel patch (LX-P) 100 mg per day for 4 weeks
Arm Title
LX-T group
Arm Type
Active Comparator
Arm Description
loxoprofen sodium tablet (LX-T) 60 mg t.i.d. for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Loxoprofen sodium hydrogel patch
Other Intervention Name(s)
Loxoprofen hydrogel patch
Intervention Description
100 mg per day
Intervention Type
Drug
Intervention Name(s)
Loxoprofen sodium tablet
Other Intervention Name(s)
Loxoprofen tablet
Intervention Description
60 mg t.i.d.
Primary Outcome Measure Information:
Title
the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% response (ASAS20)
Description
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)
Time Frame
week 4
Secondary Outcome Measure Information:
Title
ASAS5/6 response
Description
defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)
Time Frame
week 4
Title
ASAS20 response
Description
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)
Time Frame
week 2
Title
ASAS5/6 response
Description
defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)
Time Frame
week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jieruo Gu, Prof
Organizational Affiliation
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Rheumatology, the Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

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

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