CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Thalidomide (100mg) +2 moredrug
Likely dose
Thalidomide (100mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02707484
NCT02707484Phase 3Completed
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A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of Efficacy of Thalidomide for Refractory Small Intestinal Bleeding From Vascular Malformation

Shanghai Jiao Tong University School of Medicine·interventional·Posted Mar 14, 2016·Updated Jun 23, 2023

In Brief

A Phase 3 clinical trial evaluating Thalidomide (100mg), Thalidomide (50mg), and 1 other intervention for Gastrointestinal Vascular Malformation. Completed, enrolled 150 participants across 10 sites.

Detailed Summary

Gastrointestinal vascular malformation (GIVM), which is an important cause of acute or chronic gastrointestinal bleeding, currently lacks of effective treatment. The investigators' previous study first confirmed thalidomide treatment of GIVM bleeding was safe and effective. This prospective multi-center randomized controlled clinical trial intends to investigate the efficacy of thalidomide to the recurrent small intestinal hemorrhage due to GIVM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Vascular Malformation
CountriesChina
CollaboratorsPeking Union Medical College Hospital, Nanfang Hospital, Southern Medical University, Xinqiao Hospital of Chongqing, Changhai Hospital, Shanghai Zhongshan Hospital, Huashan Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 14, 2016
Enrollment StartApr 1, 2016
Primary CompletionDec 1, 2020
Study CompletionApr 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 10.3 years ago

Interventions

Thalidomide (100mg)drug

Patients were randomly assigned to receive a 120-days course of 100 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).

Thalidomide (50mg)drug

Patients were randomly assigned to receive a 120-days course of 50 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).

placebodrug

Patients were randomly assigned to receive a 120-days course of placebo (Pharmaceutical Co., Ltd. of ChangZhou, China).