Iron Deficiency AnemiaPhase 1NCT02518568
Ferrous Sulphate Supplement (V0355) in Women With Iron Deficiency Anaemia
A Phase 1 study testing V0355 in people with Iron Deficiency Anemia, run by Pierre Fabre Medicament at 2 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the pharmacokinetics of serum iron after a single oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron deficiency anaemia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- V0355
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2015to May 2016
- Phase
- Phase 1
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 18-45 years inclusive with iron deficiency anaemia
- haemoglobin level between 85 g/L and 105 g/L
- serum ferritin level < 15 µg/L
- D14 +/- 7 days of the menstruation cycle on the day of pharmacokinetic evaluation
Who cannot join
- Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,
- Haemochromatosis or iron overload of secondary origin (blood transfusion),
- Long term treatment known to modify iron absorption,
- Gastro duodenal ulcer,
- Inflammatory bowel disease or any digestive disease which could modify iron absorption,
- Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders),
- Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Study of the Pharmacokinetics of Serum Iron After a Single Oral Administration of Ferrous Sulphate Supplement Synthetic Formula in Women With Iron Deficiency Anaemia.
The purpose of this study is to investigate the pharmacokinetics of serum iron after a single oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron deficiency anaemia.
- Conditions
- Iron Deficiency Anemia
- Being tested
- V0355
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V0355Drug
Oral administration (2 tablets)
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | Not described Receives: Drug: V0355 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma concentration (Cmax)
Measured: up to 24 hours after oral administration
Time to Maximum Concentration (Tmax)
Measured: up to 24 hours after oral administration
Area under the iron plasma concentration curve (AUC)
Measured: up to 24 hours after oral administration
Secondary outcomes (1)
Tolerability of single administration
Tolerability by evaluating the number of subjects with emergent adverse events
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518568
- Sponsor's protocol ID
- V00355 CP 1 02
- Other IDs
- 2015-000544-42, 2015
- Status last verified
- Sep 2016
- First submitted
- 4 Aug 2015
- Last updated
- 28 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Pharmacokinetics of Serum Iron After a Single Oral Administration of Ferrous Sulphate Supplement Synthetic Formula in Women With Iron Deficiency Anaemia.
- ClinicalTrials.gov ID
- NCT02518568
- Acronym / sponsor ID
- V00355 CP 1 02
- Conditions
- Iron Deficiency Anemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Aug 2015 (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 purpose of this study is to investigate the pharmacokinetics of serum iron after a single oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron deficiency anaemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: V0355 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women 18-45 years inclusive with iron deficiency anaemia
- haemoglobin level between 85 g/L and 105 g/L
- serum ferritin level < 15 µg/L
- D14 +/- 7 days of the menstruation cycle on the day of pharmacokinetic evaluation
Key exclusion criteria (7 listed)
- Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,
- Haemochromatosis or iron overload of secondary origin (blood transfusion),
- Long term treatment known to modify iron absorption,
- Gastro duodenal ulcer,
- Inflammatory bowel disease or any digestive disease which could modify iron absorption,
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 |
|---|---|---|
| V0355Oral administration (2 tablets) | Drug | Drug |
Primary outcome
Maximum Plasma concentration (Cmax)
Time frame: up to 24 hours after oral administration
Time to Maximum Concentration (Tmax)
Time frame: up to 24 hours after oral administration
Area under the iron plasma concentration curve (AUC)
Time frame: up to 24 hours after oral administration
1 secondary outcome
Tolerability of single administration
Time frame: Up to 24 hours
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing V0355 in people with Iron Deficiency Anemia, run by Pierre Fabre Medicament at 2 sites in 2 countries.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bulgaria, Romania. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early. Results are not available in the source record.
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?
Maximum Plasma concentration (Cmax) (time frame: up to 24 hours after oral administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2016.