Iron Deficiency AnemiaPhase 3NCT01425463
A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects
A Phase 3 study testing Ferrous (II) Glycine Sulphate Complex and Polyferose in people with Iron Deficiency Anemia, run by Sanol GmbH at 15 sites in China.
Trial summary
To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron Deficiency Anemia. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferrous (II) Glycine Sulphate Complex and Polyferose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 15 sitesChina
- Study dates
- Mar 2011to Nov 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- An iron deficiency anemia patient with Serum Ferritin < 12 ng/mL, serum Hb-values >60 and < 120 g/L in males, < 110 g/L in females
Who cannot join
- With any Mal-absorption Syndrome
- With a history of Thalassemia or Sickle Cell Anemia
- With untreated concurrent Vitamin B12 or Folate deficiency at Baseline
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
15
Changsha
16
Changsha
1
Fuzhou
10
Guangzhou
5
Hangzhou
6
Hangzhou
7
Jinan
8
Jinan
13
Shanxi
14
Shanxi
12
Shenyang
2
Tianjin
17
Wenzhou
4
Wuxi
9
Xi'an
About this study
Official title: A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized and Multi-center Trial to Investigate Efficacy and Safety in Subjects With Iron Deficiency Anemia for Ferrous (II) Glycine Sulphate Complex Versus Polyferose Capsules Therapy
To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron Deficiency Anemia.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferrous (II) Glycine Sulphate Complex, Polyferose, Placebo to Ferrous (II) Glycine Sulphate Complex, Placebo to Polyferose
- Keywords
- Ferrous (II) Glycine Sulphate Complex, Polyferose, Ferro Sanol duodenal, Niferex, Iron Deficiency Anemia
- 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.
Ferrous (II) Glycine Sulphate ComplexDrug
Also called Ferro Sanol Duodenal
Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
PolyferoseDrug
Also called Nifirex
Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.
Placebo to Ferrous (II) Glycine Sulphate ComplexOther
Administered orally with water.
Placebo to PolyferoseOther
Administered orally with water.
| Study group | Role | What they receive |
|---|---|---|
| Ferrous (II) Glycine Sulphate Complex | Experimental | Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose. Receives: Drug: Ferrous (II) Glycine Sulphate Complex; Other: Placebo to Polyferose |
| Polyferose | Active comparator | Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex. Receives: Drug: Polyferose; Other: Placebo to Ferrous (II) Glycine Sulphate Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12
Measured: From Baseline to Week 12
Secondary outcomes (4)
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2
Measured: From Baseline to Week 2
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4
Measured: From Baseline to Week 4
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8
Measured: From Baseline to Week 8
Percentage of Responders at Week 12
Responders are defined as having an increment of Hemoglobin (Hb) > 15 g/L and post-treatment Hb > 120 g/L (male) or > 110 g/L (female) at Visit 6 (Week 12).
Measured: End of Treatment Period (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanol GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425463
- Sponsor's protocol ID
- SP0986
- Other IDs
- 2014-004380-20, 2014
- Status last verified
- May 2015
- First submitted
- 26 Aug 2011
- Last updated
- 1 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized and Multi-center Trial to Investigate Efficacy and Safety in Subjects With Iron Deficiency Anemia for Ferrous (II) Glycine Sulphate Complex Versus Polyferose Capsules Therapy
- ClinicalTrials.gov ID
- NCT01425463
- Acronym / sponsor ID
- SP0986
- Conditions
- Iron Deficiency Anemia
- Keywords
- Ferrous (II) Glycine Sulphate Complex, Polyferose, Ferro Sanol duodenal, Niferex, Iron Deficiency Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Sanol GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Posted 6 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron Deficiency Anemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous (II) Glycine Sulphate Complex | Experimental | Drug: Ferrous (II) Glycine Sulphate Complex, Other: Placebo to PolyferoseFerrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose. |
| Polyferose | Active comparator | Drug: Polyferose, Other: Placebo to Ferrous (II) Glycine Sulphate ComplexPolyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- An iron deficiency anemia patient with Serum Ferritin < 12 ng/mL, serum Hb-values >60 and < 120 g/L in males, < 110 g/L in females
Key exclusion criteria (3 listed)
- With any Mal-absorption Syndrome
- With a history of Thalassemia or Sickle Cell Anemia
- With untreated concurrent Vitamin B12 or Folate deficiency at Baseline
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 |
|---|---|---|
| Ferrous (II) Glycine Sulphate ComplexAlso: Ferro Sanol DuodenalOral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks). Administered orally with water. | Drug | Ferrous (II) Glycine Sulphate Complex |
| PolyferoseAlso: NifirexOral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks). Administered orally with water. | Drug | Polyferose |
| Placebo to Ferrous (II) Glycine Sulphate ComplexAdministered orally with water. | Other | Polyferose |
| Placebo to PolyferoseAdministered orally with water. | Other | Ferrous (II) Glycine Sulphate Complex |
Primary outcome
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12
Time frame: From Baseline to Week 12
4 secondary outcomes
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2
Time frame: From Baseline to Week 2
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4
Time frame: From Baseline to Week 4
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8
Time frame: From Baseline to Week 8
Percentage of Responders at Week 12
Time frame: End of Treatment Period (Week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferrous (II) Glycine Sulphate Complex and Polyferose in people with Iron Deficiency Anemia, run by Sanol GmbH at 15 sites in China.
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 1 inclusion and 3 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 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. 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?
Yes. Results are posted in the registry (first posted 6 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12 (time frame: From Baseline to Week 12). 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 1 Jun 2015.