Gastrointestinal HemorrhagePhase 4NCT00978575
Iron Substitution After Upper Gastro-Intestinal Bleeding
A Phase 4 study testing ferricarboxymaltose and Ferrosulfate in people with Gastrointestinal Hemorrhage and Anemia, run by University of Aarhus at 1 site in Denmark.
Trial summary
The trial is a double-blind randomized trial designed to examine whether compliant iron therapy (intravenous or oral) for 3 months after discharge increases hemoglobin levels more and faster than no treatment - in patients with acute bleeding from upper gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage, Anemia
- What is being tested?
- ferricarboxymaltose and Ferrosulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Apr 2013
- Phase
- Phase 4
- 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
- Acute upper gastrointestinal bleeding
- Anemia
Who cannot join
- Liver disease
- Terminal cancer
- Kidney disease
- variceal bleeding
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Compliant Oral Iron Treatment (FerroDuretter ®) for 3 Months After Discharge Versus Single-dose of Intravenous Iron (Ferinject ®) Before Discharge in Patients With Acute Bleeding From Upper Gastrointestinal Tract. A Double Blinded Randomized Trial
The trial is a double-blind randomized trial designed to examine whether compliant iron therapy (intravenous or oral) for 3 months after discharge increases hemoglobin levels more and faster than no treatment - in patients with acute bleeding from upper gastrointestinal tract. The trial will include 126 patients at Aarhus University Hospital. In addition to efficacy assessment quality of life assessment and health economic calculations between the treatments will be compared.
- Conditions
- Gastrointestinal Hemorrhage, Anemia
- Being tested
- ferricarboxymaltose, Ferrosulfate, Placebo
- Keywords
- Iron treatment, Upper gastrointestinal bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferricarboxymaltoseDrug
Also called Ferinject
Single dose of maximum 1000 mg ferricarboxymaltose intravenous
FerrosulfateDrug
Also called FerroDuretter
200mg daily for 12 weeks
PlaceboDrug
100 mg isotonic sodium and 2 placebo tablets daily
| Study group | Role | What they receive |
|---|---|---|
| Intravenous iron | Active comparator | Not described Receives: Drug: ferricarboxymaltose |
| Oral iron | Active comparator | Not described Receives: Drug: Ferrosulfate |
| Isotonic Sodium and placebo tablets | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
haemoglobin
Measured: 13 weeks
Secondary outcomes (1)
Quality of life Health economics
Measured: 13 weeks, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startApr 2010
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Vifor Pharma
- Responsible party
- Principal investigator, Palle Bager, University of Aarhus
- Investigators
- Hendrik Vilstrup, Professor, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978575
- Sponsor's protocol ID
- Iron Gab
- Status last verified
- Apr 2013
- First submitted
- 16 Sep 2009
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bager P, Dahlerup JF. Randomised clinical trial: oral vs. intravenous iron after upper gastrointestinal haemorrhage--a placebo-controlled study. Aliment Pharmacol Ther. 2014 Jan;39(2):176-87. doi: 10.1111/apt.12556. Epub 2013 Nov 19.
PubMed 24251969
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Compliant Oral Iron Treatment (FerroDuretter ®) for 3 Months After Discharge Versus Single-dose of Intravenous Iron (Ferinject ®) Before Discharge in Patients With Acute Bleeding From Upper Gastrointestinal Tract. A Double Blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT00978575
- Acronym / sponsor ID
- Iron Gab
- Conditions
- Gastrointestinal Hemorrhage, Anemia
- Keywords
- Iron treatment, Upper gastrointestinal bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- GCP-unit at Aarhus University Hospital, Aarhus, Denmark, Vifor Pharma
- Study start
- Apr 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial is a double-blind randomized trial designed to examine whether compliant iron therapy (intravenous or oral) for 3 months after discharge increases hemoglobin levels more and faster than no treatment - in patients with acute bleeding from upper gastrointestinal tract. The trial will include 126 patients at Aarhus University Hospital. In addition to efficacy assessment quality of life assessment and health economic calculations between the treatments will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous iron | Active comparator | Drug: ferricarboxymaltose |
| Oral iron | Active comparator | Drug: Ferrosulfate |
| Isotonic Sodium and placebo tablets | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute upper gastrointestinal bleeding
- Anemia
Key exclusion criteria (5 listed)
- Liver disease
- Terminal cancer
- Kidney disease
- variceal bleeding
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ferricarboxymaltoseAlso: FerinjectSingle dose of maximum 1000 mg ferricarboxymaltose intravenous | Drug | Intravenous iron |
| FerrosulfateAlso: FerroDuretter200mg daily for 12 weeks | Drug | Oral iron |
| Placebo100 mg isotonic sodium and 2 placebo tablets daily | Drug | Isotonic Sodium and placebo tablets |
Primary outcome
haemoglobin
Time frame: 13 weeks
1 secondary outcome
Quality of life Health economics
Time frame: 13 weeks, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
- Derived from this study: PubMed 24251969Bager P, Dahlerup JF. Randomised clinical trial: oral vs. intravenous iron after upper gastrointestinal haemorrhage--a placebo-controlled study. Aliment Pharmacol Ther. 2014 Jan;39(2):176-87. doi: 10.1111/apt.12556. Epub 2013 Nov 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik Vilstrup, Professor study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ferricarboxymaltose and Ferrosulfate in people with Gastrointestinal Hemorrhage and Anemia, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 5 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 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
haemoglobin (time frame: 13 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 NCT00978575, which also lists 1 linked publication.
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 5 Apr 2013; AzTrials last refreshed its copy on 29 Oct 2026.