search
Back to results

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

Primary Purpose

Ankylosing Spondylitis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Fengshigutong Capsule plus Imrecoxib
Fengshigutong Capsule
Imrecoxib
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, Fengshigutong Capsule, imrecoxib

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 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Fengshigutong Capsule plus Imrecoxib

Fengshigutong Capsule

Imrecoxib

Arm Description

Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally

Fengshigutong Capsule 1.2g twice a day,orally

Imrecoxib 0.1g twice a day,orally

Outcomes

Primary Outcome Measures

the proportions of patients reaching Assessment in Ankylosing Spondylitis 20%
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

the proportions of patients reaching Assessment in Ankylosing Spondylitis 50%
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
April 26, 2019
Last Updated
April 26, 2019
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT03932006
Brief Title
A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis
Official Title
A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2016 (Actual)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
May 31, 2019 (Anticipated)

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
ankylosing spondylitis, Fengshigutong Capsule, imrecoxib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fengshigutong Capsule plus Imrecoxib
Arm Type
Experimental
Arm Description
Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
Arm Title
Fengshigutong Capsule
Arm Type
Experimental
Arm Description
Fengshigutong Capsule 1.2g twice a day,orally
Arm Title
Imrecoxib
Arm Type
Active Comparator
Arm Description
Imrecoxib 0.1g twice a day,orally
Intervention Type
Drug
Intervention Name(s)
Fengshigutong Capsule plus Imrecoxib
Intervention Description
Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
Intervention Type
Drug
Intervention Name(s)
Fengshigutong Capsule
Intervention Description
Fengshigutong Capsule 1.2g twice a day,orally
Intervention Type
Drug
Intervention Name(s)
Imrecoxib
Intervention Description
Imrecoxib 0.1g twice a day,orally
Primary Outcome Measure Information:
Title
the proportions of patients reaching Assessment in Ankylosing Spondylitis 20%
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
4 week
Secondary Outcome Measure Information:
Title
the proportions of patients reaching Assessment in Ankylosing Spondylitis 50%
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
4 week
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
4 week
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
4 week

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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jieruo Gu, Prof
Phone
+8620-85252055
Email
gujieruo@163.com
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
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jieruo Gu, Prof
Phone
+8620-85252055
Email
gujieruo@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs