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

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03932006
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 35
• Patients Per Site Per Month: 5.1

Study Details

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	Intervention/Treatment	Phase
Ankylosing Spondylitis	Drug: Fengshigutong Capsule plus Imrecoxib; Drug: Fengshigutong Capsule; Drug: Imrecoxib	Phase 4

Study Design

• Study Type: Interventional
• Anticipated 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: Jun 30, 2016
• Anticipated Primary Completion Date: May 31, 2019
• Anticipated Study Completion Date: May 31, 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% [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% [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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gu Jieruo, Division of Rheumatology of Third Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT03932006
• Other Study ID Numbers: [2015]2-159
• First Posted: Apr 30, 2019
• Last Update Posted: Apr 30, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Gu Jieruo, Division of Rheumatology of Third Affiliated Hospital of Sun Yat-sen University, Sun Yat-sen University: ankylosing spondylitis; Fengshigutong Capsule; imrecoxib
• Additional relevant MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing

Study Results

No Results Posted as of Apr 30, 2019