|
Main
|
|
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:
|
EUCTR |
|
Last refreshed on:
|
30 June 2019 |
|
Main ID: |
EUCTR2010-023797-39-GB |
|
Date of registration:
|
16/07/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE
|
|
Scientific title:
|
TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY. - TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD. |
|
Date of first enrolment:
|
12/08/2011 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023797-39 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Patients with IDA complicating their IBD. Anaemia will be defined by age and sex-adjusted World Health Organisation criteria. Because serum ferritin is an acute phase reactant, patients with iron deficiency will be defined by a transferrin saturation <16%.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
Exclusion criteria:
- Patients who cannot read English, as not all of the questionnaires in the study have been validated in Non-English languages.
- Patients who present to the clinic and who are overtly ill requiring admission will also be excluded.
- Patients who are anaemic for a different reason, including folic acid, B12 deficiency, as a result of thiopurine use (pancytopenia), or with co-existent haemaglobinopathies or myelodysplasia.
- Patients under the age of 13 and over the age of 90.
- Patients with severe cardiopulmonary disease, hepatic or renal impairment, pregnancy, alcohol or drug abuse.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Inflammatory bowel disease
MedDRA version: 14.1
Level: LLT
Classification code 10045365
Term: Ulcerative colitis
System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1
Level: PT
Classification code 10011401
Term: Crohn's disease
System Organ Class: 10017947 - Gastrointestinal disorders
|
|
Intervention(s)
|
Trade Name: Iron sulphate 200mg coated tablets
Product Name: Ferrous sulphate
Product Code: Ferrous sulphate
Pharmaceutical Form: Tablet
INN or Proposed INN: Iron sulphate
CAS Number: 7720-78-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Trade Name: CosmoFer
Product Name: CosmoFer 50mg/ml solution for infusion or injection
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: iron(III)- hydroxide dextran complex
CAS Number: 9004-66-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
|
|
Primary Outcome(s)
|
Secondary Objective: 1. Oral iron does not adversely affect IBD symptoms or objective markers of inflammation.
2. A raised serum hepcidin level will reduce the response to iron therapy.
3. Oral iron improves health-related QOL, perceived stress, mood disorders and fatigue.
4. Treatment of anaemia restores ANS homeostasis and improves exercise tolerance in IBD.
|
Main Objective: Is there a difference in the response to treatment with iron supplementation in adolescents and adults in IBD?
We hypothesise that there is no difference in the haematological response to treatment of iron deficiency anaemia with oral iron in adults and adolescents with IBD.
|
|
Primary end point(s): Primary outcome: Mean increase in haemoglobin after 6 weeks of treatment.
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|