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

NCT03800797 | Completed Phase 4

• 1 other identifier: [2014]2-135
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis; loxoprofen; patch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ASAS5/6 response

  week 4

• ASAS20 response

  week 2

• ASAS5/6 response

  week 2

Study Arms (2)

LX-P group

EXPERIMENTAL

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

Drug: Loxoprofen sodium hydrogel patch

LX-T group

ACTIVE COMPARATOR

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

Drug: Loxoprofen sodium tablet

Interventions

Loxoprofen sodium hydrogel patch DRUG

100 mg per day

Also known as: Loxoprofen hydrogel patch

LX-P group

Loxoprofen sodium tablet DRUG

60 mg t.i.d.

Also known as: Loxoprofen tablet

LX-T group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

loxoprofen

Condition Hierarchy (Ancestors)

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

Study Officials

• Jieruo Gu, Prof

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Rheumatology, The Third Affiliated Hospital of Sun Yat-Sen University

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 11, 2019
• Study Start: May 25, 2015
• Primary Completion: December 10, 2015
• Study Completion: December 10, 2015
• Last Updated: January 11, 2019

Record last verified: 2015-12

Locations

CN (1)