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AngiodysplasiaPhase 3OCEANNCT02384122

Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias

A Phase 3 study testing Octreotide in people with Angiodysplasia and Vascular Malformations, run by Radboud University Medical Center at 12 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Octreotide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
12 sitesNetherlands
Study dates
Sep 2015to May 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Endoscopically diagnosed angiodysplasias
  • Transfusion dependency: at least 4 red blood cell transfusions (per 500 ml or packed cells) and/or parental iron infusions (per 500 mg) in the year before inclusion
  • Failure of endoscopic therapy: at least one endoscopic attempt to coagulate the angiodysplasias or unsuitable for endoscopic procedures
  • Providing informed consent
  • Older than 18 years

Who cannot join

  • Liver cirrhosis Child-Pugh C, liver failure or diagnosed portal hypertension
  • Previous treatment with octreotide for the same indication (refractory anemia due to angiodysplasias)
  • Current thalidomide treatment which is effective (no transfusion dependency)
  • Life expectancy < 1 year
  • Left ventricular assist devices (LVAD's)
  • Hereditary hemorrhagic diseases or hematological disorders with active treatment
Show all 11Show fewer
  • Pregnancy or nursing women
  • Uncontrolled diabetes as defined by HbA1C >64 mmol/ml, despite adequate therapy
  • Known hypersensitivity to somatostatin analogs
  • Symptomatic cholecystolithiasis
  • Systemic cancer under active treatment (chemotherapy or radiation therapy)

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Netherlands12 sites

  • Jeroen Bosch Hospital

    's-Hertogenbosch, North Brabant, 5200 ME

  • Gelre Hospital

    Apeldoorn, Gelderland, 7334 DZ

  • Rijnstate Hospital

    Arnhem, 6815AD

  • Reinier de Graaf Gasthuis

    Delft, South Holland, 2625 AD

  • Catharina Hospital

    Eindhoven, North Brabant, 5623 EJ

  • University Medical Center Groningen (UMCG)

    Groningen, 9713GZ

  • Tjongerschans Hospital

    Heerenveen, 8441 PW

  • St. Antonius Hospital

    Nieuwegein, Utrecht, 3430 EM

  • Radboud University Medical Center (Radboudumc)

    Nijmegen, Gelderland, 6525GA

  • Maasstad Hospital

    Rotterdam

  • Elisabeth-TweeSteden Hospital

    Tilburg, North Brabant, 5022 GC

  • Bernhoven Hospital

    Uden, 5406 PT

Other trials in Netherlands

About this study

Official title: A Multicenter, Randomized, Open-label Clinical Trial Assessing the Efficacy of Octreotide in Decreasing Blood and Iron Requirements in Patients With Refractory Anemia Due to Angiodysplasias

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.

Read the detailed description

Rationale: Gastrointestinal angiodysplasias are a common source of intractable small bowel bleeding, especially in older patients. Endoscopic ablation of angiodysplasias has limited efficacy and rebleeding rates are substantial. Recurrent bleeding results in refractory anemia which is managed with blood transfusions and/or iron infusions. Transfusion dependency reduces quality of life and is associated with substantial cardiovascular morbidity and mortality. Small cohort studies suggest a beneficial effect of octreotide in bleeding angiodysplasias, but evidence from rigorous, well-controlled studies are lacking.

Objective: To assess the efficacy of octreotide in reducing the transfusion requirements (consisting of blood transfusions and iron infusions) of patients with refractory anemia due to gastrointestinal angiodysplasias despite endoscopic intervention.

Study design: Multicenter, randomized, open-label intervention study.

Study population: Patients aged 18 years or older with transfusion-dependent anemia due to endoscopically confirmed angiodysplasias. Transfusion units consist of iron infusions (of 500 milligrams [mg]) and red blood cell (RBC) transfusions. At least one endoscopic attempt to treat the angiodysplasias needs to be recorded unless contra-indications are present. Patients with liver cirrhosis Child-Pugh C or liver failure, uncontrolled diabetes mellitus (defined by a glycated hemoglobin >64 mmol/mL), symptomatic cholecystolithiasis, and pregnant or nursing women, are regarded as ineligible because of the pharmacological profile of octreotide. Patients with hereditary hemorrhagic diseases or hematological disorders on active treatment, other alternative causes of gastrointestinal bleeding, presence of left ventricular assist devices, as well as patients with cancer under active treatment, and those with a life expectancy <1 year are excluded from enrolment

Intervention: Patients will be randomized (1:1) into two groups. The intervention group receives 40 mg octreotide long-acting release (Sandostatin LAR) every 28 days for a total period of 52 weeks as an adjunct to standard of care. The control group receives standard of care along. The last follow-up visit is in week 60.

Main study parameters/endpoints: The primary endpoint is defined as the mean difference in blood (RBC transfusions per 500 ml or packed cells) and parenteral iron (IV iron infusions per 500 mg) requirements between the intervention and control group, corrected for baseline transfusion requirements and follow-up time.

Being tested
Octreotide
Keywords
Angiodysplasias, Sandostatin LAR, Gastrointestinal bleeding, Somatostatin analogs, Octreotide
Medical subject headings
Angiodysplasia, Vascular Malformations, Gastrointestinal Hemorrhage, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OctreotideDrug

    Also called Sandostatin LAR, RVG 18236, ATC H01CB02

    Two injections of 20 mg will be given monthly.

Study groups in NCT02384122
Study groupRoleWhat they receive
OctreotideActive comparatorDrug: Sandostatin LAR Sandostatin LAR 40 mg will be administered once every 4 weeks as a intramuscular injection
Receives: Drug: Octreotide
Standard of careNo interventionPatients receive standard of care without a placebo.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in blood and parenteral iron requirements (transfusion units)

    The mean difference in blood (RBC transfusions per 500 ml or packed cells) and parenteral iron (IV iron infusions per 500 mg) requirements between the intervention and standard of care arm, corrected for baseline transfusion requirements and follow-up time.

    Measured: Study year (52 weeks)

Secondary outcomes (12)

  1. Proportion with a good treatment response

    The proportion of patients in both groups that experienced a ≥50% (defined as a good response) and 100% (defined as a full response) reduction in the number of transfusion units received during the study year compared to baseline

    Measured: During the study year (52 weeks) compared to the year (52 weeks) before randomization

  2. Use of concomitant care

    The proportion of patients in both groups that required concomitant care. Concomitant care consists of application of APC, discontinuation of antithrombotics, use of tranexamic acid, and starting octreotide in the control group.

    Measured: Study year (52 weeks)

  3. Difference in endoscopic procedures

    The mean difference in endoscopic procedures between both groups.

    Measured: Study year (52 weeks)

  4. Difference in bleeding episodes

    The mean difference in bleeding episodes between both groups. A bleeding episode is defined as each non-contiguous episode in which hospital care is sought for anemia.

    Measured: Study year (52 weeks)

  5. Difference in healthcare utilization

    The mean difference in healthcare utilization between both groups. Healthcare utilization consists of hospital admissions, ambulatory care, and emergency care.

    Measured: Study year (52 weeks)

  6. Difference in hemoglobin levels

    The mean difference in serum hemoglobin levels (mmol/L) between both groups.

    Measured: Study year (52 weeks)

  7. Difference in ferritin levels

    The mean difference in serum ferritin levels (ug/L) between both groups.

    Measured: Study year (52 weeks)

  8. Difference in fatigue levels

    The mean difference in fatigue levels between both groups. Fatigue is a patient-reported outcome measure (PROM), measured by the Multidimensional Fatigue Inventory (MFI-20), which covers five dimensions of fatigue affect and -tolerability. MFI-20 scores range from 20 (best) to 100 (worst).

    Measured: Study year (52 weeks)

  9. Difference in quality of life

    The mean difference in quality of life between both groups. Quality of life is a patient-reported outcome measure (PROM), measured by the Short Form Health Survey (SF-36), which uses eight subdomains to evaluate physical- and mental health. SF-36 scores range from 0 (worst) to 100 (best).

    Measured: Study year (52 weeks)

  10. Difference in adverse events

    The proportion of patients in both groups that experienced at least one adverse event (AE).

    Measured: Study year (52 weeks)

  11. Difference in serious adverse events

    The proportion of patients in both groups that experienced at least one serious adverse event (SAE).

    Measured: Study year (52 weeks)

  12. Difference in mortality

    The proportion of patients in both groups that died during the study.

    Measured: Study year (52 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionJul 2022
  4. Study completionMay 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, open-label, randomized, parallel-group, superiority study to compare the efficacy of 40 mg octreotide long-acting release intramuscular every 28 days in addition to standard of care versus standard of care alone in patients with refractory anemia due to gastrointestinal bleeding from angiodysplasias.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02384122
Sponsor's protocol ID
NLOCEAN.50514.091.14
Acronym
OCEAN
Status last verified
Apr 2023
First submitted
4 Mar 2015
Last updated
24 May 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Deidentified individual participant data and a data dictionary defining each field in the set will be available, upon reasonable request to Lia Goltstein and subjected to an appropriate data sharing agreement.

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.

    PubMed 38158089

  • 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.

    PubMed 27619827

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Octreotide in people with Angiodysplasia and Vascular Malformations, run by Radboud University Medical Center at 12 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in blood and parenteral iron requirements (transfusion units) (time frame: Study year (52 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02384122, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.

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