Ankylosing SpondylitisPhase 4NCT00953979
Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis
A Phase 4 study testing kunxian capsule in people with Ankylosing Spondylitis and Treatment, run by Gu Jieruo at 1 site in China.
Trial summary
This is a prospective randomized controlled study to evaluated the efficacy and safety of kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major outcome index is proportion of patients achieving ASAS20 response at week12, and minor outcome indexes include ASAS50 and ASAS70… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis, Treatment
- What is being tested?
- kunxian capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2009
- 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
- 16 to 65 years old, having signed the informed consent;
- fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
- BASDAI score more than 4;
- stop taking DMARDs for at least 4 weeks;
- NSAIDs dosage has been stable for at least 4 weeks;
Who cannot join
- Intra-articular injection of cortisone within 3 months.
- History of heart failure, multiple sclerosis, COPD, lymphoma or other tumors;
- Accompanied by fibromyalgia or other rheumatic diseases;
- Female of pregnancy or breast feeding;
- History of mental disease and poor compliance.
- History of drug abuse or alcoholism.
Trial locations and contacts
1 site in 1 country.
China1 site
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
Official title: A Clinical Trial About the Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis: a 12-week, Multi-center, Randomized, Double-blind, Active Drug and Placebo Compared Clinical Trial
This is a prospective randomized controlled study to evaluated the efficacy and safety of kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major outcome index is proportion of patients achieving ASAS20 response at week12, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. The adverse events at any time were recorded to evaluate the safety.
- Conditions
- Ankylosing Spondylitis, Treatment
- Being tested
- kunxian capsule
- Keywords
- ankylosing spondylitis, treatment, Sulfasalazine, kunxian capsule
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kunxian capsuleDrug
The main element of kunxian capsule is Tripterygium. Patients should take 2 tablets per time and 3 times per day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sulfasalazine | Active comparator | Sulfasalazine is a drug in treatment RA, AS and ulcerative colonitis. In this study, Sulfasalazine is used to act as an active comparator to access the efficacy of kunxian capsule. Receives: Drug: kunxian capsule |
| placebo | Placebo comparator | The placebo capsule was used to be a comparator of kunxian capsule Receives: Drug: kunxian capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients achieving ASAS20 response
Measured: 12th week
Secondary outcomes (1)
proportion of patients achieving BASDAI20/50/70 response
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJan 2008
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gu Jieruo
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Dongguan People's Hospital, Zhujiang Hospital, Huashan Hospital
- Responsible party
- Sponsor-investigator, Gu Jieruo, Sun Yat-sen University
- Investigators
- Jieruo Gu, M.D., Principal investigator, Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953979
- Sponsor's protocol ID
- 2008-2
- Status last verified
- Jan 2012
- First submitted
- 5 Aug 2009
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li Q, Li L, Bi L, Xiao C, Lin Z, Cao S, Liao Z, Gu J. Kunxian capsules in the treatment of patients with ankylosing spondylitis: a randomized placebo-controlled clinical trial. Trials. 2016 Jul 22;17(1):337. doi: 10.1186/s13063-016-1438-6.
PubMed 27449221
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial About the Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis: a 12-week, Multi-center, Randomized, Double-blind, Active Drug and Placebo Compared Clinical Trial
- ClinicalTrials.gov ID
- NCT00953979
- Acronym / sponsor ID
- 2008-2
- Conditions
- Ankylosing Spondylitis, Treatment
- Keywords
- ankylosing spondylitis, treatment, Sulfasalazine, kunxian capsule
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Gu JieruoUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital, Dongguan People's Hospital, Zhujiang Hospital, Huashan Hospital
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Aug 2009 (estimated)
- 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 prospective randomized controlled study to evaluated the efficacy and safety of kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major outcome index is proportion of patients achieving ASAS20 response at week12, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. The adverse events at any time were recorded to evaluate the safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulfasalazine | Active comparator | Drug: kunxian capsuleSulfasalazine is a drug in treatment RA, AS and ulcerative colonitis. In this study, Sulfasalazine is used to act as an active comparator to access the efficacy of kunxian capsule. |
| placebo | Placebo comparator | Drug: kunxian capsuleThe placebo capsule was used to be a comparator of kunxian capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 16 to 65 years old, having signed the informed consent;
- fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
- BASDAI score more than 4;
- stop taking DMARDs for at least 4 weeks;
- NSAIDs dosage has been stable for at least 4 weeks;
Key exclusion criteria (6 listed)
- Intra-articular injection of cortisone within 3 months.
- History of heart failure, multiple sclerosis, COPD, lymphoma or other tumors;
- Accompanied by fibromyalgia or other rheumatic diseases;
- Female of pregnancy or breast feeding;
- History of mental disease and poor compliance.
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 |
|---|---|---|
| kunxian capsuleThe main element of kunxian capsule is Tripterygium. Patients should take 2 tablets per time and 3 times per day for 12 weeks. | Drug | Sulfasalazine, placebo |
Primary outcome
proportion of patients achieving ASAS20 response
Time frame: 12th week
1 secondary outcome
proportion of patients achieving BASDAI20/50/70 response
Time frame: 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2012.
- Derived from this study: PubMed 27449221Li Q, Li L, Bi L, Xiao C, Lin Z, Cao S, Liao Z, Gu J. Kunxian capsules in the treatment of patients with ankylosing spondylitis: a randomized placebo-controlled clinical trial. Trials. 2016 Jul 22;17(1):337. doi: 10.1186/s13063-016-1438-6.
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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, M.D. principal investigator
Rheumatology Department, 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 kunxian capsule in people with Ankylosing Spondylitis and Treatment, run by Gu Jieruo 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 19 Jan 2012. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients achieving ASAS20 response (time frame: 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00953979, which also lists 1 linked publication.
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 19 Jan 2012.