Ankylosing SpondylitisPhase 4NCT03932006
A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis
A Phase 4 study testing Fengshigutong Capsule plus Imrecoxib, Fengshigutong Capsule and Imrecoxib in people with Ankylosing Spondylitis, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Fengshigutong Capsule plus Imrecoxib, Fengshigutong Capsule and Imrecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2016to 31 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Peptic ulcer
- Unstable cardiac diseases
- Hematologic disorders
- Psychosis
- Malignancy
- Multiple sclerosis
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Jieruo Gu, Prof, +8620-85252055, gujieruo@163.com
About this study
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.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Fengshigutong Capsule plus Imrecoxib, Fengshigutong Capsule, Imrecoxib
- Keywords
- ankylosing spondylitis, Fengshigutong Capsule, imrecoxib
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fengshigutong Capsule plus ImrecoxibDrug
Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
Fengshigutong CapsuleDrug
Fengshigutong Capsule 1.2g twice a day,orally
ImrecoxibDrug
Imrecoxib 0.1g twice a day,orally
| Study group | Role | What they receive |
|---|---|---|
| Fengshigutong Capsule plus Imrecoxib | Experimental | Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally Receives: Drug: Fengshigutong Capsule plus Imrecoxib |
| Fengshigutong Capsule | Experimental | Fengshigutong Capsule 1.2g twice a day,orally Receives: Drug: Fengshigutong Capsule |
| Imrecoxib | Active comparator | Imrecoxib 0.1g twice a day,orally Receives: Drug: Imrecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 week
Secondary outcomes (3)
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)
Measured: 4 week
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)
Measured: 4 week
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)
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start30 Jun 2016
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gu Jieruo, Sun Yat-sen University
- Investigators
- Jieruo Gu, Prof, Study director, Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932006
- Sponsor's protocol ID
- [2015]2-159
- Status last verified
- Apr 2019
- First submitted
- 26 Apr 2019
- Last updated
- 30 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter，Double-Blind and Randomized Controlled Trial of Fengshigutong Capsule in the Treatment of Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT03932006
- Acronym / sponsor ID
- [2015]2-159
- Conditions
- Ankylosing Spondylitis
- Keywords
- ankylosing spondylitis, Fengshigutong Capsule, imrecoxib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fengshigutong Capsule plus Imrecoxib | Experimental | Drug: Fengshigutong Capsule plus ImrecoxibFengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally |
| Fengshigutong Capsule | Experimental | Drug: Fengshigutong CapsuleFengshigutong Capsule 1.2g twice a day,orally |
| Imrecoxib | Active comparator | Drug: ImrecoxibImrecoxib 0.1g twice a day,orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- Peptic ulcer
- Unstable cardiac diseases
- Hematologic disorders
- Psychosis
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fengshigutong Capsule plus ImrecoxibFengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally | Drug | Fengshigutong Capsule plus Imrecoxib |
| Fengshigutong CapsuleFengshigutong Capsule 1.2g twice a day,orally | Drug | Fengshigutong Capsule |
| ImrecoxibImrecoxib 0.1g twice a day,orally | Drug | Imrecoxib |
Primary outcome
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)
3 secondary outcomes
the proportions of patients reaching Assessment in Ankylosing Spondylitis 50%
Time frame: 4 week
ASAS20 response
Time frame: 4 week
ASAS5/6 response
Time frame: 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jieruo Gu, Prof study director
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fengshigutong Capsule plus Imrecoxib, Fengshigutong Capsule and Imrecoxib in people with Ankylosing Spondylitis, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jieruo Gu, Prof (+8620-85252055, gujieruo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% (time frame: 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.