Trials / Terminated
TerminatedNCT01428843
Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
A Controlled, Randomised, Double-blind, Multicenter Study, Comparing Ferrisat Versus Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This is due to iron deficiency and inflammation. Most of treatments aim to control inflammation using anti-TNF alpha therapy which should theorically reduce anemia. The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should reduce anemia and improve quality of life of patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FERRISAT | A single infusion of 50 mg/ml of Ferrisat during inclusion visit. |
| DRUG | PLACEBO | A single infusion of Glucose 5% solution during inclusion visit |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2011-09-05
- Last updated
- 2015-06-23
Locations
18 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01428843. Inclusion in this directory is not an endorsement.