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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.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02874326
Date of registration: 17/08/2016
Prospective Registration: Yes
Primary sponsor: Radboud University
Public title: Octreotide in Patients With GI Bleeding Due to Rendu-Osler-Weber ROW
Scientific title: An Uncontrolled, Pilot-study Assessing the Efficacy of Octreotide Long-acting Release to Decrease Transfusion Requirements and Endoscopy Frequency in Patients With Rendu-Osler-Weber and Gastrointestinal Bleeding
Date of first enrolment: October 2016
Target sample size: 15
Recruitment status: Unknown status
URL:  https://clinicaltrials.gov/show/NCT02874326
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Netherlands
Contacts
Name:     Joost Drenth, MD PhD
Address: 
Telephone:
Email:
Affiliation:  Radboud University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with Rendu-Osler-Weber

- Symptomatic gastrointestinal bleeds out of telangiectasias

- Transfusion and / or endoscopy dependent:

Transfusion: at least 2 blood and/or iron infusions in the 6 months before inclusion.

Endoscopy: at least one endoscopy with APC after the initial endoscopic treatment after
diagnosis in the half year before inclusion or unsuitable for endoscopic therapy.

Exclusion Criteria:

- liver cirrhosis Child-Pugh C or acute liver failure

- previous unsuccessful treatment with somatostatin analogues (SST) for the same
indication (refractory anaemia due to telangiectasias) or current effective treatment
with a somatostatin analogue

- severe diseases with life expectancy < 1 year

- patients with left ventricular assist devices (LVAD's)

- Symptomatic cholecystolithiasis (without cholecystectomy)

- pregnancy or nursing women or women who have a pregnancy wish in the study period or
who use anticonception inadequate

- current chemotherapy

- patients with a known hypersensitivity to SST analogues or any component of the
octreotide LAR formulations

- no understanding of Dutch or English



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Gastrointestinal Hemorrhage
Anemia
Hereditary Hemorrhagic Telangiectasia
Intervention(s)
Drug: Octreotide LAR
Primary Outcome(s)
The percentage of patients who are full responder, partial responder and non-responder at the end of the treatment period [Time Frame: Comparing the 6 months before inclusion and the study period (26 weeks)]
Secondary Outcome(s)
The percentual decrease in blood and iron requirements [Time Frame: Comparing the 6 months prior to inclusion and the treatment period of 6 months.]
The percentual decrease in the number of endoscopic interventions [Time Frame: Comparing the 6 months prior to inclusion and the treatment period of 6 months.]
The number, type and severity of adverse events [Time Frame: Study period]
Change in quality of life using the Short Form (SF)-36 questionnaire [Time Frame: Comparing baseline and end of treatment visit]
The mean/median decrease on the epistaxis severity score (ESS) [Time Frame: Comparing the 6 months prior to inclusion and the treatment period of 6 months.]
Secondary ID(s)
NLROW.1012.15
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
St. Antonius Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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