Inflammatory Bowel DiseasesPhase 2/3NCT02044952
Efficacy and Safety Study of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission
A Phase 2/3 study testing Mesalazine, Tripterygium glycosides in people with Inflammatory Bowel Diseases and Crohn's Disease, run by Zhu Weiming at 1 site in China.
Trial summary
The purpose of this study is to assess the effect and safety of Tripterygium Glycosides in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who received mesalazine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn's Disease, Gastrointestinal Diseases
- What is being tested?
- Mesalazine, Tripterygium glycosides
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jul 2016
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria.
- Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
- Subjects should have a CDAI score between 150 to 270 at week 0.
- Able to swallow tablets.
- Are capable of providing written informed consent and obtained at the time of enrollment.
- Willing to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Bacterial, viral or other microbial infection(including HIV).
- Orally administered corticosteroids within 3 weeks before enrollment, Inhaled or dermatologic preparations for the treatment of other diseases are acceptable.
- Used of infliximab or immunosuppressant within 2 months before enrollment.
- Previous use of prescription doses of NSAIDs without efficacy.
- Treatment with narcotic pain medications(Anti-diarrheal agents such as loperamide and diphenoxylate are permitted).
- History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis).
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- History of abnormal liver function tests, including AST or ALT >1.5 times upper limit of normal, alkaline phosphatase >2 times upper limit of normal, total bilirubin >2.5 mg/dL at screening (or within the previous 6 months, if known).
- History of malignancy.
- Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.
- Participation in other clinical trial within the past 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Surgery Institute, Jinling Hospital
Nanjing, Jiangsu, 210000
wei ming zhu, PhD,MD, +86-25-80860137, dr_zhuweiming@126.com
About this study
Official title: Prospective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission
The purpose of this study is to assess the effect and safety of Tripterygium Glycosides in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who received mesalazine.
Read the detailed description
Crohn's disease is characterized by inflammation and ulceration of the small intestine and colon. Patients commonly experience abdominal pain, diarrhea，malnutrition and malaise which result in decreased quality of life and an increased risk of chronic disability and unemployment.
Tripterygium Glycosides(T2) is a chloroform/methanol extract Tripterygium wilfordii Hook F (TWHF), the traditional Chinese medicine, used in rheumatoid arthritis and nephritis. It has both immune-modulatory and anti-inflammatory activities. Our previous animal studies have revealed that the major component of T2, triptolide, could prevent the development of chronic colitis in interleukin-10 deficient mice. The phase I clinical trial in our institute also demonstrated that T2 is efficient for induction of remission in patients with mild to moderate active crohn's disease. The common adverse effects of T2 are leucopenia, liver renal toxicity, oligospermia and amenorrhea.
The purpose of this study is to assess the effect and safety of Tripterygium Glycosides in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received mesalazine.
- Conditions
- Inflammatory Bowel Diseases, Crohn's Disease, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases
- Being tested
- Mesalazine, Tripterygium glycosides
- Keywords
- Crohn's Disease, mesalazine, Tripterygium Glycosides, induction remission
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesalazine, Tripterygium glycosidesDrug
Also called Triptolide, Lei gong teng, Thunder god vine
tripterygium glycosides: 2mg/kg/d, oral Mesalazine: 4g/d, oral
| Study group | Role | What they receive |
|---|---|---|
| Mesalazine, Tripterygium glycosides | Experimental | Mesalazine 4g/d and Tripterygium glycosides 2mg/kg/d for 12 weeks Receives: Drug: Mesalazine, Tripterygium glycosides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic effect measured by Crohn's Disease Activity Index (CDAI)
Measured: 12 weeks
Secondary outcomes (4)
The Side effects of Tripterygium wilfordii (TW)
Measured: 12 weeks
The change of Crohn's Disease Activity Index (CDAI )
Measured: 12Weeks
The change of Simple Endoscopic Score for Crohn's Disease(SES-CD)
Measured: 12 Weeks
The change of the Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhu Weiming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Weiming, Jinling Hospital, China
- Investigators
- wei ming zhu, PhD,MD, Principal investigator, General Surgery Institute, Jinling Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044952
- Sponsor's protocol ID
- CDTW-1
- Status last verified
- Jan 2014
- First submitted
- 19 Jan 2014
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Experimental of Tripterygium Glycoside in the Treatment of Crohn's Disease for Induction Remission
- ClinicalTrials.gov ID
- NCT02044952
- Acronym / sponsor ID
- CDTW-1
- Conditions
- Inflammatory Bowel Diseases, Crohn's Disease, Gastrointestinal Diseases, Digestive System Diseases, Intestinal Diseases
- Keywords
- Crohn's Disease, mesalazine, Tripterygium Glycosides, induction remission
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhu WeimingUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 24 Jan 2014 (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.
The purpose of this study is to assess the effect and safety of Tripterygium Glycosides in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who received mesalazine.
Detailed description
Crohn's disease is characterized by inflammation and ulceration of the small intestine and colon. Patients commonly experience abdominal pain, diarrhea，malnutrition and malaise which result in decreased quality of life and an increased risk of chronic disability and unemployment.
Tripterygium Glycosides(T2) is a chloroform/methanol extract Tripterygium wilfordii Hook F (TWHF), the traditional Chinese medicine, used in rheumatoid arthritis and nephritis. It has both immune-modulatory and anti-inflammatory activities. Our previous animal studies have revealed that the major component of T2, triptolide, could prevent the development of chronic colitis in interleukin-10 deficient mice. The phase I clinical trial in our institute also demonstrated that T2 is efficient for induction of remission in patients with mild to moderate active crohn's disease. The common adverse effects of T2 are leucopenia, liver renal toxicity, oligospermia and amenorrhea.
The purpose of this study is to assess the effect and safety of Tripterygium Glycosides in the treatment of Crohn's disease for induction remission and compare the therapeutic effect with patients who only received mesalazine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesalazine, Tripterygium glycosides | Experimental | Drug: Mesalazine, Tripterygium glycosidesMesalazine 4g/d and Tripterygium glycosides 2mg/kg/d for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria.
- Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
- Subjects should have a CDAI score between 150 to 270 at week 0.
- Able to swallow tablets.
- Are capable of providing written informed consent and obtained at the time of enrollment.
Key exclusion criteria (10 listed)
- Bacterial, viral or other microbial infection(including HIV).
- Orally administered corticosteroids within 3 weeks before enrollment, Inhaled or dermatologic preparations for the treatment of other diseases are acceptable.
- Used of infliximab or immunosuppressant within 2 months before enrollment.
- Previous use of prescription doses of NSAIDs without efficacy.
- Treatment with narcotic pain medications(Anti-diarrheal agents such as loperamide and diphenoxylate are permitted).
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 |
|---|---|---|
| Mesalazine, Tripterygium glycosidesAlso: Triptolide, Lei gong teng, Thunder god vinetripterygium glycosides: 2mg/kg/d, oral Mesalazine: 4g/d, oral | Drug | Mesalazine, Tripterygium glycosides |
Primary outcome
Therapeutic effect measured by Crohn's Disease Activity Index (CDAI)
Time frame: 12 weeks
4 secondary outcomes
The Side effects of Tripterygium wilfordii (TW)
Time frame: 12 weeks
The change of Crohn's Disease Activity Index (CDAI )
Time frame: 12Weeks
The change of Simple Endoscopic Score for Crohn's Disease(SES-CD)
Time frame: 12 Weeks
The change of the Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
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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.
wei ming zhu, PhD,MD principal investigator
General Surgery Institute, Jinling Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mesalazine, Tripterygium glycosides in people with Inflammatory Bowel Diseases and Crohn's Disease, run by Zhu Weiming 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 6 inclusion and 10 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 24 Jan 2014. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 wei ming zhu, PhD,MD (+86-25-80860137, dr_zhuweiming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic effect measured by Crohn's Disease Activity Index (CDAI) (time frame: 12 weeks). 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 24 Jan 2014.