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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03932006
Other study ID # [2015]2-159
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 30, 2016
Est. completion date May 31, 2019

Study information

Verified date April 2019
Source Sun Yat-sen University
Contact Jieruo Gu, Prof
Phone +8620-85252055
Email gujieruo@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Drug:
Fengshigutong Capsule plus Imrecoxib
Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
Fengshigutong Capsule
Fengshigutong Capsule 1.2g twice a day,orally
Imrecoxib
Imrecoxib 0.1g twice a day,orally

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 4 week
Secondary 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) 4 week
Secondary 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) 4 week
Secondary 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) 4 week
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