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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT02956538 |
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Date of registration:
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13/10/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide
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Scientific title:
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Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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72 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02956538 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 0
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Countries of recruitment
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China
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Contacts
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Name:
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Xiang Peng, MM |
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Address:
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Telephone:
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18302076916 |
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Email:
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stefaniepx@163.com |
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Affiliation:
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Name:
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Xiang Peng, MM |
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Address:
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Telephone:
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18302076916 |
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Email:
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stefaniepx@163.com |
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Affiliation:
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Name:
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Xiang gao, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sixth Affiliated Hospital, Sun Yat-sen University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18-50 years old
- Diagnosis of patients with CD
- Disease in the activity: CDA ? > 150 points, endoscopic see active lesions
- Refractory: immunosuppressive drugs or biological agents which are used in current
treatment is invalid and/or intolerance
Exclusion Criteria:
- Fiber stenosis caused by gastrointestinal obstruction symptoms
- Fistula exclude anal fistula
- Pregnancy or lactation
- Period of women have fertility program during the study
- Treatment not foot eight weeks after last IFX
- Central or peripheral nerve disease
- Abnormal in liver and renal function
- Heart function failure
- Malignant tumor
- Active tuberculosis
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Drug: placebo(for thalidomide)
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Drug: Thalidomide
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Primary Outcome(s)
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difference CDAI between thalidomide group and placebo group
[Time Frame: 8 weeks]
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difference SES-CD score between thalidomide group and placebo group
[Time Frame: 8weeks]
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Secondary Outcome(s)
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difference SES-CD score between different thalidomide dosage group
[Time Frame: 1 year]
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difference CDAI between different thalidomide dosage group
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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