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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001077-13 | EudraCT Number |
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The trial was terminated due to insufficient enrollment.
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The objective of the study is to evaluate and compare the frequency and severity of GI adverse events in different dose administration regimens. The patient population consists of low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day deferasirox or an evening dose of the same. Patients are then followed up for 6 months for any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deferasirox am | Experimental | Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food |
|
| Deferasirox pm | Experimental | Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferasirox | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Frequency of Overall Newly Occurring GI Adverse Events (AEs) in the Two Treatment Arms | Study was prematurely terminated and not powered for efficacy. Frequency of GI AEs during the overall study period is available in the AE tables reported in the safety section. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Frequency of Overall Newly Occurring GI AEs Between the Two Treatment Groups at Month 6. | Study was prematurely terminated and not powered for efficacy. | 6 months |
| Difference in Frequency of Specific Commonly Reported GI AEs Between the Two Treatment Groups |
Not provided
Inclusion Criteria:
Deferasirox naïve:
Sexually active pre-menopausal female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Caen | Cedex | 14033 | France | ||
| Novartis Investigative Site |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Deferasirox am | Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food |
| FG001 | Deferasirox pm | Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Deferasirox am | Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food |
| BG001 | Deferasirox pm | Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in the Frequency of Overall Newly Occurring GI Adverse Events (AEs) in the Two Treatment Arms | Study was prematurely terminated and not powered for efficacy. Frequency of GI AEs during the overall study period is available in the AE tables reported in the safety section. | Posted | 3 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ICL am | ICL am |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D000077588 | Deferasirox |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Study was prematurely terminated and not powered for efficacy. |
| months 3 and 6. |
| Difference in Severity of Overall GI AEs Between the Two Treatment Groups | Study was prematurely terminated and not powered for efficacy. | months 3 and 6. |
| Difference in Severity of Specific Commonly Reported GI Symptoms Between the Two Treatment Groups | Study was prematurely terminated and not powered for efficacy. | months 3 and 6 |
| Difference in Frequency and Severity of All Non-GI AEs Between the Two Treatment Groups | Study was prematurely terminated and not powered for efficacy. | months 3 and 6 |
| the Difference Between the Time From Baseline to the First Occurrence of GI AEs Between the Two Treatment Groups | Study was prematurely terminated and not powered for efficacy. | 3 months, 6 months |
| Difference in Severity of GI Symptoms, Bowel Habits and Level of Satisfaction From the Patient's Perspective Between the Two Treatment Groups | 3 months, 6 months |
| Difference in Reducing Serum Ferritin After Each Month of Study Drug Administration Between the Two Groups | Study was prematurely terminated and not powered for efficacy. | 3 months, 6 months |
| Brest |
| 29200 |
| France |
| Novartis Investigative Site | Limoges | 87042 | France |
| Novartis Investigative Site | Pessac | 33604 | France |
| Novartis Investigative Site | Vandœuvre-lès-Nancy | 54511 | France |
| Novartis Investigative Site | Alessandria | AL | 15100 | Italy |
| Novartis Investigative Site | Torino | TO | 10126 | Italy |
| Novartis Investigative Site | Roma | 00133 | Italy |
| Novartis Investigative Site | Bloemfontein | 901 | South Africa |
| Novartis Investigative Site | Madrid | Madrid | 28033 | Spain |
| Misisng |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Difference in Frequency of Overall Newly Occurring GI AEs Between the Two Treatment Groups at Month 6. | Study was prematurely terminated and not powered for efficacy. | Posted | 6 months |
|
|
| Secondary | Difference in Frequency of Specific Commonly Reported GI AEs Between the Two Treatment Groups | Study was prematurely terminated and not powered for efficacy. | Posted | months 3 and 6. |
|
|
| Secondary | Difference in Severity of Overall GI AEs Between the Two Treatment Groups | Study was prematurely terminated and not powered for efficacy. | Posted | months 3 and 6. |
|
|
| Secondary | Difference in Severity of Specific Commonly Reported GI Symptoms Between the Two Treatment Groups | Study was prematurely terminated and not powered for efficacy. | Posted | months 3 and 6 |
|
|
| Secondary | Difference in Frequency and Severity of All Non-GI AEs Between the Two Treatment Groups | Study was prematurely terminated and not powered for efficacy. | Posted | months 3 and 6 |
|
|
| Secondary | the Difference Between the Time From Baseline to the First Occurrence of GI AEs Between the Two Treatment Groups | Study was prematurely terminated and not powered for efficacy. | Posted | 3 months, 6 months |
|
|
| Secondary | Difference in Severity of GI Symptoms, Bowel Habits and Level of Satisfaction From the Patient's Perspective Between the Two Treatment Groups | Posted | 3 months, 6 months |
|
|
| Secondary | Difference in Reducing Serum Ferritin After Each Month of Study Drug Administration Between the Two Groups | Study was prematurely terminated and not powered for efficacy. | Posted | 3 months, 6 months |
|
|
| 1 |
| 7 |
| 5 |
| 7 |
| EG001 | ICL pm | ICL pm | 2 | 5 | 2 | 5 |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Lyme disease | Infections and infestations | MedDRA | Systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |