NCT03932006

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

2.9 years

First QC Date

April 26, 2019

Last Update Submit

April 26, 2019

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitisFengshigutong Capsuleimrecoxib

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • the proportions of patients reaching Assessment in Ankylosing Spondylitis 50%

    4 week

  • ASAS20 response

    4 week

  • ASAS5/6 response

    4 week

Study Arms (3)

Fengshigutong Capsule plus Imrecoxib

EXPERIMENTAL

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

Drug: Fengshigutong Capsule plus Imrecoxib

Fengshigutong Capsule

EXPERIMENTAL

Fengshigutong Capsule 1.2g twice a day,orally

Drug: Fengshigutong Capsule

Imrecoxib

ACTIVE COMPARATOR

Imrecoxib 0.1g twice a day,orally

Drug: Imrecoxib

Interventions

Fengshigutong Capsule plus ImrecoxibDRUG

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

Fengshigutong Capsule plus Imrecoxib
Fengshigutong CapsuleDRUG

Fengshigutong Capsule 1.2g twice a day,orally

Fengshigutong Capsule
ImrecoxibDRUG

Imrecoxib 0.1g twice a day,orally

Imrecoxib

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Imrecoxib

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • Jieruo Gu, Prof

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

    STUDY DIRECTOR

Central Study Contacts

Jieruo Gu, Prof

CONTACT

+8620-85252055gujieruo@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division of Rheumatology of Third Affiliated Hospital of Sun Yat-sen University

Study Record Dates

First Submitted

April 26, 2019

First Posted

April 30, 2019

Study Start

June 30, 2016

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

April 30, 2019

Record last verified: 2019-04

Locations

CN(1)