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A Multicenter,Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis

  • Clinicaltrials.gov identifier

    NCT03932006

  • Recruitment Status

    Recruiting

  • First Posted

    April 30, 2019

  • Last update posted

    April 30, 2019

Study Description

Brief summary:

This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Fengshigutong Capsule in the treatment of active ankylosing spondylitis(AS). The primary purpose is to assess the different maintaining treatment programme in AS patients with controlled inflammation by Imrecoxib. The trial will include 180 patients who will be divided into three group: Fengshigutong Capsule plus Imrecoxib group, Imrecoxib group and Fengshigutong Capsule group. Patients will complete the 4-week therapy.

  • Condition or Disease:Ankylosing Spondylitis
  • Intervention/Treatment: Drug: Fengshigutong Capsule plus Imrecoxib
    Drug: Fengshigutong Capsule
    Drug: Imrecoxib
  • Phase: Phase 4

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 180 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Multicenter,Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis
  • Actual Study Start Date: June 2016
  • Estimated Primary Completion Date: May 2019
  • Estimated Study Completion Date: May 2019

Arms and interventions

Arm Intervention/treatment
Experimental: Fengshigutong Capsule plus Imrecoxib
Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
Drug: Fengshigutong Capsule plus Imrecoxib
Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
Experimental: Fengshigutong Capsule
Fengshigutong Capsule 1.2g twice a day,orally
Drug: Fengshigutong Capsule
Fengshigutong Capsule 1.2g twice a day,orally
Active Comparator: Imrecoxib
Imrecoxib 0.1g twice a day,orally
Drug: Imrecoxib
Imrecoxib 0.1g twice a day,orally

Outcome Measures

  • Primary Outcome Measures: 1. the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% [ Time Frame: 4 week ]
    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. the proportions of patients reaching Assessment in Ankylosing Spondylitis 50% [ Time Frame: 4 week ]
    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: 4 week ]
    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: 4 week ]
    defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP)

Eligibility Criteria

  • Ages Eligible for Study: 18 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 7 days prior to randomization

- DMARDs washout period of at least 4 weeks prior to randomization

- Corticosteroids washout period of at least 2 weeks prior to randomization

- Biological agents washout period of at least 3 months prior to randomization.

Exclusion Criteria:

- Peptic ulcer

- Unstable cardiac diseases

- Hematologic disorders

- Psychosis

- Malignancy

- Multiple sclerosis

- severe COPD

- fibromyalgia and other rheumatic disease

- Corticosteroids were injected into the articular cavity within 3 months

- Chinese medicine was taken within 28 days

- Pregnant and lactating women

- Alcohol and drug abuse

- Spinal cord compression

Contacts and Locations

Contacts

Contact: Jieruo Gu, Prof +8620-85252055 gujieruo@163.com

Locations

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

Sponsors and Collaborators

Sun Yat-sen University

Investigators

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

More Information

  • Responsible Party: Sun Yat-sen University
  • ClinicalTrials.gov Identifier: NCT03932006 History of Changes
  • Other Study ID Numbers: [2015]2-159
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: April 30, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Sun Yat-sen University: ankylosing spondylitis
    Fengshigutong Capsule
    imrecoxib
  • Additional relevant MeSH terms: Spondylitis Spondylitis, Ankylosing