Obscure Gastrointestinal Bleeding Clinical Trial
Official title:
Long-term Effects of Thalidomide for Recurrent Gastrointestinal Bleeding Due to Vascular Malformation : An Open-label, Randomized, Parallel Controlled Study
Verified date | August 2009 |
Source | Shanghai Jiao Tong University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
Background: Repeated episodes of bleeding from gastrointestinal vascular malformations
refractory to endoscopic or surgical therapy often pose a major therapeutic challenge.
Methods: The investigators performed a randomized, parallel controlled study of thalidomide
as a therapy for recurrent gastrointestinal bleeding due to vascular malformation. Patients
with at least six episodes of bleeding in the prior year due to vascular malformation were
randomly grouped, prescribed a four-month regimen of either 25 mg of thalidomide or 100 mg
of iron orally four times daily, and monitored for at least one year. The primary end point
was defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months and
the cessation of bleeding. Rebleeding was defined based on a positive fecal occult blood
test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment.
Secondary outcomes included the participants dependent on blood transfusions and changes
from baseline in transfused packed red cell units, bleeding episodes, bleeding durations,
and hemoglobin levels at 12 months. Statistical significance was defined at P < 0.05.
Status | Completed |
Enrollment | 55 |
Est. completion date | August 2009 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Age between 40-85 years; women were post-menopausal, post-tubal ligation, or on some form of birth control like long-term laying up contraceptive ring or using condom; - History of at least six documented gastrointestinal bleeding episodes in the year prior to randomization, which were refractory or inaccessible to endoscopic therapy or surgical ectomy; - Confirmed diagnosis of vascular malformation by esophagogastroduodenoscopy (EGD), capsule endoscope (CE), double-balloon endoscope (DBE), or colonoscopy, but no obvious infectious, neoplastic, or other specific diagnosis; - Angiodysplasia at endoscopy characterized by focal or diffused venous/capillary lesions presenting as bright red ectatic vessels or pulsatile red protrusions, with surrounding venous dilatation or patchy erythema with or without oozing; - Endoscopic appearance of GAVE (also known as watermelon stomach), indicated by longitudinal antral folds converging on the pylorus, containing visible columns of tortuous red ecstatic vessels. Exclusion Criteria: - Patients were excluded if their bleeding history were less than 1 year; - if they had cirrhotic or portal hypertension gastropathy; severe co-morbidities of cardiac, pulmonary, renal, liver, hematological, rheumatologic disorders, or uncontrollable diabetes mellitus or hypertension; - if they had a history of severe bilateral peripheral neuropathy or seizure activity, thromboembolic disease, known thalidomide or iron allergy, or prior treatment of gastrointestinal bleeding with thalidomide; - if they had a history of treatment with any dose of systemic or oral topical corticosteroids or aspirin, NSAIDs, anti-platelet drugs, anticoagulants, or Chinese medications (with salicylates), gingko, or Echinacea, or other putative immunomodulators or anti-angiogenic agents; - Currently pregnant or lactating or currently undergoing systemic cancer chemotherapy or receiving radiation - if they were undergoing systemic cancer chemotherapy or receiving radiation. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Shanghai Jiao Tong University School of Medicine |
Bauditz J, Schachschal G, Wedel S, Lochs H. Thalidomide for treatment of severe intestinal bleeding. Gut. 2004 Apr;53(4):609-12. — View Citation
Jacobson JM, Greenspan JS, Spritzler J, Ketter N, Fahey JL, Jackson JB, Fox L, Chernoff M, Wu AW, MacPhail LA, Vasquez GJ, Wohl DA. Thalidomide for the treatment of oral aphthous ulcers in patients with human immunodeficiency virus infection. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group. N Engl J Med. 1997 May 22;336(21):1487-93. — View Citation
Shurafa M, Kamboj G. Thalidomide for the treatment of bleeding angiodysplasias. Am J Gastroenterol. 2003 Jan;98(1):221-2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants Whose Rebleeds Decreased From Baseline by = 50% at 12 Months | The primary end point was defined as the patients whose rebleeds decreased from baseline by = 50% at 12 months. Reduction of rebleeds = [(total bleeding episode at 12 months - total bleeding episodes at a year before randomization)/total bleeding episodes at a year before randomization(baseline)]*100%. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. | baseline and 12 months | No |
Primary | Cessation of Bleeding | The cessation of bleeding was defined as repeated negative faecal occult blood test (FOBT) (monoclonal colloidal gold color technology) during our observation period. Rebleeding was defined based on a positive FOBT at any visit after treatment. | 52 months | No |
Secondary | Change From Baseline in Hemoglobin (Hb) Level at 12 Months | The change from baseline in average hemoglobin (Hb) level(tested every month) at 12 months. | baseline and 12 months | No |
Secondary | Change From Baseline in Bleeding Episodes at 12 Months | The Change from baseline in bleeding episodes at 12 months | baseline and 12 months | No |
Secondary | Change From Baseline in Bleeding Duration at 12 Months | The change from baseline in bleeding duration at 12 months | baseline and 12 months | No |
Secondary | Participants Dependent on Blood Transfusions | Numbers of participants dependent on blood transfusions | 52 months | No |
Secondary | Change From Baseline in Total Transfused Red Cell Requirements at 12 Months | Change of total transfused red cell requirements at 12 months after randomization from one year before baseline in transfusion dependent patients | baseline and 12 months | No |
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