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Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide

NCT ID: NCT02956538

Last Updated: 2016-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-10-31

Brief Summary

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With the development and application of biological agents, the treatment effect was considerable degree improvement on refractory corn's disease. However, there are quite a part of the CD patients lost response during treatment of using response. Moreover, due to various reasons, there still a lot limited on the using of biological agents in China, that make quite a part of the refractory CD patients lack of further medical treatment options. There has been a RCT study which prove that thalidomide effect and safety on treating refractory CD or who were lost response by using biological agents in Italy, but the object of study is only limited in children and adolescents. There are some small sample studies also confirmed the efficacy and safety on refractory corn's disease by using thalidomide, but need more RCT evidence.

Detailed Description

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It will be divided two groups of patients by using randomized, double-blind. One group was treated by thalidomide, the other was placebo. It will be unlocked blind and analysis the effect and safety about thalidomide after 8 weeks. The second, patients still use thalidomide after unlock blind to prove its longtime treatment effect and safety.

Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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thalidomide

thalidomide 100mg tablet by mouth, every night for 8 weeks

Group Type EXPERIMENTAL

Thalidomide

Intervention Type DRUG

placebo

placebo (for thalidomide) 100mg tablet by mouth, every night for 8 weeks

Group Type ACTIVE_COMPARATOR

placebo(for thalidomide)

Intervention Type DRUG

sugar pill manufactured to mimic thalidomide 100mg tablet

Interventions

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Thalidomide

Intervention Type DRUG

placebo(for thalidomide)

sugar pill manufactured to mimic thalidomide 100mg tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-50 years old
* Diagnosis of patients with CD
* Disease in the activity: CDA Ⅰ \> 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Xiang Gao

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiang gao, MD

Role: STUDY_CHAIR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

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Department of Gastroenterology

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiang Peng, MM

Role: CONTACT

Phone: 18302076916

Email: [email protected]

Min Zhi, MD

Role: CONTACT

Phone: 13502076916

Email: [email protected]

Facility Contacts

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Xiang Peng, MM

Role: primary

Other Identifiers

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E2016022

Identifier Type: -

Identifier Source: org_study_id