drugset / Trial / NCT02384122
Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias
Phase 3
Completed
62 enrolled
Radboud University Medical Center
Bernhoven Hospital · collabCatharina Ziekenhuis Eindhoven · collabElisabeth-TweeSteden Ziekenhuis · collabGelre Hospitals · collabJeroen Bosch Ziekenhuis · collabMaasstad Hospital · collabReinier de Graaf Groep · collabRijnstate Hospital · collabSt. Antonius Hospital · collabTjongerschans hospital · collabUniversity Medical Center Groningen · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to determine whether 40 mg octreotide long-acting release intramuscular every 28 days is effective in the treatment of patients with refractory anemia due to gastrointestinal angiodysplasias. We hypothesize that octreotide is effective in reducing the transfusion requirements (consisting of red blood cell transfusions and intravenous iron infusions) of patients with angiodysplasia-related anemia.
Timeline
- Start
- 2015-09
- Primary completion
- 2022-07
- Completion
- 2023-05
Publications
- Goltstein LCMJ, Grooteman KV, Bernts LHP, Scheffer RCH, Laheij RJF, Gilissen LPL, Schrauwen RWM, Talstra NC, Zuur AT, Braat H, Hadithi M, Brouwer JT, Nagengast WB, Oort FA, Tenthof van Noorden J, Kievit W, van Geenen EJM, Drenth JPH. Standard of Care Versus Octreotide in Angiodysplasia-Related Bleeding (the OCEAN Study): A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Apr;166(4):690-703. doi: 10.1053/j.gastro.2023.12.020. Epub 2023 Dec 28.
- Grooteman KV, van Geenen EJ, Drenth JP. Multicentre, open-label, randomised, parallel-group, superiority study to compare the efficacy of octreotide therapy 40 mg monthly versus standard of care in patients with refractory anaemia due to gastrointestinal bleeding from small bowel angiodysplasias: a protocol of the OCEAN trial. BMJ Open. 2016 Sep 12;6(9):e011442. doi: 10.1136/bmjopen-2016-011442.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Octreotide | Peptide | 40 mg | Intramuscular |