A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00390858
Collaborator
(none)
40
4
1
53
10
0.2
Study Details
Study Description
Brief Summary
In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed. Patients who successfully completed the main 1 year trial (NCT00390858) were eligible to continue in this extension trial and receive chelation therapy with deferasirox for up to 4 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 4-year Extension to a Phase II a Multicenter Study Evaluating Long-term Safety, Tolerability, Pharmacokinetics and Effects on Liver Iron Concentration of Repeated Doses of 10 mg/kg/Day of Deferasirox in Pediatric Patients With Transfusion Dependent β-thalassemia Major.
Study Start Date
:
Sep 1, 2003
Actual Primary Completion Date
:
Feb 1, 2008
Actual Study Completion Date
:
Feb 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Deferasirox Initial dose of 10 mg/kg, dose modifications of ± 5 or 10 mg/kg were based on participant response. |
Drug: Deferasirox
Deferasirox in children from 1 to 18 years old was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters and on increasing or decreasing Liver Iron Concentration (LIC), and serum ferritin. Deferasirox was available as 125 mg, 250 mg and 500 mg tablets.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Participants With Adverse Events by Primary System Organ Class (SOC) [4 year extension + core 1 year]
Safety parameters were measured by the number and type of adverse events (AEs). An adverse event is any untoward medical occurence in a patient administered a medicinal product that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign ( for example, an abnormal laboratory finding), symptom or disease temporally associated with the use of the medicinal product, whether or not this is associated with the use of this medicinal product.
- Change in Liver Iron Concentration (LIC) [Baseline of Core Study to End of Extension Study, up to 5 years.]
Change in Liver Iron Concentration [LIC] measured by means of SQUID (Superconducting Quantum Interference Device). LIC is expressed in milligrams of iron per gram of liver dry weight (mg Fe/g dw)
Secondary Outcome Measures
- Total Body Iron Elimination (TBIE) Rate (mg/kg/Day) [Baseline of Core Study to End of Extension Study, up to 5 years]
Total Iron Body Elimination (TBIE) Rate [mg/kg/Day] was calculated for each patient based on SQUID ( Superconducting Quantum Interference Device) results.
- Relative Change in Serum Ferritin Level [Baseline of Core Study to Extension 18 months, up to 2.5 years.]
Serum levels were drawn at the baseline of the Core Study up to 18 months of the Extension Study. Levels were analyzed for serum ferritin measured in micrograms per Liter. Relative change (%) in serum ferritin level was assessed from Baseline to Extension 18 months. Relative Change = 1 - (Change in ferritin level from Baseline/Baseline level) x 100.
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Completion of the planned 12-month core trial, (NCT00390858).
-
Female patients who have reached menarche and who were sexually active were to use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
-
Written informed consent obtained from the patient, and/or from the parent or legal guardian in accordance with the national legislation.
Exclusion Criteria:
-
Pregnant or breast feeding patients
-
Patients with a history of non-compliance to medical regimens and patients who are considered by the investigator as potentially unreliable.
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Lyon | France | ||
| 2 | Novartis Investigative Site | Cagliari | Italy | ||
| 3 | Novartis Investigative Site | Genova | Italy | ||
| 4 | Novartis Investigative Site | Torino | Italy |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Dr. Gianluca Forni, Novartis Pharmaceuticals
- Study Director: Prof. Renzo Galanello, Novartis Pharmaceuticals
- Study Director: Prof. Antonio Piga, Novartis Pharmaceuticals
- Study Director: Dr. Yves Bertrand, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00390858
Other Study ID Numbers:
- CICL670A0106E1
First Posted:
Oct 20, 2006
Last Update Posted:
Mar 20, 2017
Last Verified:
Feb 1, 2017
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Children ( < 12 Years) | Adolescents ( ≧12 Years) |
|---|---|---|
| Arm/Group Description | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing |
| Period Title: Overall Study | ||
| STARTED | 20 | 20 |
| Completed Core & Entered Extension Study | 19 | 20 |
| COMPLETED | 11 | 13 |
| NOT COMPLETED | 9 | 7 |
Baseline Characteristics
| Arm/Group Title | Children (<12 Years) | Adolescents ( ≧12 Years) | Total |
|---|---|---|---|
| Arm/Group Description | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing | Total of all reporting groups |
| Overall Participants | 20 | 20 | 40 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
6.7
(2.83)
|
14.1
(1.64)
|
10.4
(4.37)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
12
60%
|
11
55%
|
23
57.5%
|
| Male |
8
40%
|
9
45%
|
17
42.5%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| Caucasian |
20
100%
|
20
100%
|
40
100%
|
Outcome Measures
| Title | Participants With Adverse Events by Primary System Organ Class (SOC) |
|---|---|
| Description | Safety parameters were measured by the number and type of adverse events (AEs). An adverse event is any untoward medical occurence in a patient administered a medicinal product that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign ( for example, an abnormal laboratory finding), symptom or disease temporally associated with the use of the medicinal product, whether or not this is associated with the use of this medicinal product. |
| Time Frame | 4 year extension + core 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set comprising of all the 40 patients who received at least one dose of deferasirox during the core or extension study was used in all analyses. |
| Arm/Group Title | Children (<12 Years) | Adolescents ( ≧12 Years) |
|---|---|---|
| Arm/Group Description | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing |
| Measure Participants | 20 | 20 |
| Patients with at least one Adverse Event (AE) |
20
100%
|
20
100%
|
| General disorders & administration site conditions |
19
95%
|
20
100%
|
| Respiratory, thoracic & mediastinal disorders |
19
95%
|
17
85%
|
| Gastrointestinal disorders |
18
90%
|
17
85%
|
| Infections & infestations |
18
90%
|
17
85%
|
| Musculoskeletal & connective tissue disorders |
12
60%
|
15
75%
|
| Investigations |
13
65%
|
10
50%
|
| Nervous system disorders |
9
45%
|
13
65%
|
| Skin & subcutaneous tissue disorders |
12
60%
|
8
40%
|
| Injury, poisoning & procedural complications |
11
55%
|
8
40%
|
| Ear & labyrinth disorders |
9
45%
|
8
40%
|
| Metabolism & nutrition disorders |
6
30%
|
10
50%
|
| Eye disorders |
6
30%
|
9
45%
|
| Renal & urinary disorders |
3
15%
|
6
30%
|
| Hepatobiliary disorders |
1
5%
|
7
35%
|
| Reproductive system & breast disorders |
0
0%
|
8
40%
|
| Cardiac disorders |
1
5%
|
5
25%
|
| Blood & lymphatic system disorders |
1
5%
|
5
25%
|
| Psychiatric disorders |
2
10%
|
4
20%
|
| Immune system disorders |
0
0%
|
2
10%
|
| Surgical & medical procedures |
0
0%
|
3
15%
|
| Endocrine disorders |
1
5%
|
1
5%
|
| Vascular disorders |
0
0%
|
2
10%
|
| Congenital, familial & genetic disorders |
1
5%
|
0
0%
|
| Title | Change in Liver Iron Concentration (LIC) |
|---|---|
| Description | Change in Liver Iron Concentration [LIC] measured by means of SQUID (Superconducting Quantum Interference Device). LIC is expressed in milligrams of iron per gram of liver dry weight (mg Fe/g dw) |
| Time Frame | Baseline of Core Study to End of Extension Study, up to 5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study. |
| Arm/Group Title | Children (<12 Years) | Adolescents ( ≧12 Years) |
|---|---|---|
| Arm/Group Description | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing |
| Measure Participants | 20 | 20 |
| Core Baseline LIC (n = 20, 20) |
6.25
(2.507)
|
5.73
(2.185)
|
| End of Extension LIC (n=19, 20) |
5.46
(3.192)
|
4.66
(3.533)
|
| Change from Baseline LIC (n=19, 20) |
-0.9
(3.85)
|
-1.10
(3.03)
|
| Title | Total Body Iron Elimination (TBIE) Rate (mg/kg/Day) |
|---|---|
| Description | Total Iron Body Elimination (TBIE) Rate [mg/kg/Day] was calculated for each patient based on SQUID ( Superconducting Quantum Interference Device) results. |
| Time Frame | Baseline of Core Study to End of Extension Study, up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study. |
| Arm/Group Title | Children (<12 Years) | Adolescents ( ≧12 Years) |
|---|---|---|
| Arm/Group Description | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing |
| Measure Participants | 20 | 20 |
| Core Baseline TBIE (n=19, 20) |
0.4292
(0.06454)
|
0.4083
(0.07158)
|
| End of Extension TBIE (n=11,14) |
0.4939
(0.05175)
|
0.4286
(0.06370)
|
| Title | Relative Change in Serum Ferritin Level |
|---|---|
| Description | Serum levels were drawn at the baseline of the Core Study up to 18 months of the Extension Study. Levels were analyzed for serum ferritin measured in micrograms per Liter. Relative change (%) in serum ferritin level was assessed from Baseline to Extension 18 months. Relative Change = 1 - (Change in ferritin level from Baseline/Baseline level) x 100. |
| Time Frame | Baseline of Core Study to Extension 18 months, up to 2.5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety set was used for all analyses. This comprised of all 40 patients who received at least one dose of deferasirox during the core or extension study. |
| Arm/Group Title | Children (<12 Years) | Adolescents ( ≧12 Years) |
|---|---|---|
| Arm/Group Description | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing |
| Measure Participants | 20 | 20 |
| Mean (Standard Deviation) [percent change] |
62.4
(53.47)
|
54.9
(64.64)
|
Adverse Events
| Time Frame | Adverse Events were collected from Core Study Baseline to Extension End of Study, up to 5 years. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Children (<12 Years) | Adolescents ( ≧12 Years) | ||
| Arm/Group Description | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing | Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing | ||
All Cause Mortality |
||||
| Children (<12 Years) | Adolescents ( ≧12 Years) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Children (<12 Years) | Adolescents ( ≧12 Years) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/20 (20%) | 8/20 (40%) | ||
| Blood and lymphatic system disorders | ||||
| Splenomegaly | 0/20 (0%) | 1/20 (5%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain upper | 0/20 (0%) | 1/20 (5%) | ||
| Pancreatitis | 0/20 (0%) | 1/20 (5%) | ||
| Pancreatitis acute | 0/20 (0%) | 1/20 (5%) | ||
| Pancreatolithiasis | 0/20 (0%) | 1/20 (5%) | ||
| General disorders | ||||
| Local swelling | 0/20 (0%) | 1/20 (5%) | ||
| Hepatobiliary disorders | ||||
| Biliary colic | 0/20 (0%) | 1/20 (5%) | ||
| Cholelithiasis | 0/20 (0%) | 2/20 (10%) | ||
| Infections and infestations | ||||
| Gastroenteritis | 1/20 (5%) | 1/20 (5%) | ||
| Infectious mononucleosis | 0/20 (0%) | 1/20 (5%) | ||
| Injury, poisoning and procedural complications | ||||
| Allergic transfusion reaction | 0/20 (0%) | 1/20 (5%) | ||
| Head injury | 1/20 (5%) | 0/20 (0%) | ||
| Investigations | ||||
| Transaminases increased | 1/20 (5%) | 1/20 (5%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 0/20 (0%) | 1/20 (5%) | ||
| Renal and urinary disorders | ||||
| Haematuria | 1/20 (5%) | 0/20 (0%) | ||
| Reproductive system and breast disorders | ||||
| Ovarian cyst | 0/20 (0%) | 1/20 (5%) | ||
| Pelvic fluid collection | 0/20 (0%) | 1/20 (5%) | ||
| Surgical and medical procedures | ||||
| Cholecystectomy | 0/20 (0%) | 2/20 (10%) | ||
| Splenectomy | 0/20 (0%) | 1/20 (5%) | ||
| Tonsillectomy | 0/20 (0%) | 1/20 (5%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Children (<12 Years) | Adolescents ( ≧12 Years) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 20/20 (100%) | 20/20 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Lymphadenopathy | 0/20 (0%) | 4/20 (20%) | ||
| Splenomegaly | 0/20 (0%) | 1/20 (5%) | ||
| Cardiac disorders | ||||
| Cardiomyopathy | 0/20 (0%) | 1/20 (5%) | ||
| Extrasystoles | 0/20 (0%) | 1/20 (5%) | ||
| Palpitations | 0/20 (0%) | 2/20 (10%) | ||
| Tachycardia | 1/20 (5%) | 2/20 (10%) | ||
| Congenital, familial and genetic disorders | ||||
| Talipes | 1/20 (5%) | 0/20 (0%) | ||
| Ear and labyrinth disorders | ||||
| Auricular pseudocyst | 0/20 (0%) | 1/20 (5%) | ||
| Ear pain | 8/20 (40%) | 4/20 (20%) | ||
| Hypoacusis | 1/20 (5%) | 0/20 (0%) | ||
| Vertigo | 1/20 (5%) | 3/20 (15%) | ||
| Endocrine disorders | ||||
| Growth hormone deficiency | 1/20 (5%) | 0/20 (0%) | ||
| Hypogonadism | 0/20 (0%) | 1/20 (5%) | ||
| Hypothyroidism | 1/20 (5%) | 0/20 (0%) | ||
| Eye disorders | ||||
| Conjunctival haemorrhage | 1/20 (5%) | 0/20 (0%) | ||
| Conjunctivitis | 3/20 (15%) | 4/20 (20%) | ||
| Conjunctivitis allergic | 1/20 (5%) | 0/20 (0%) | ||
| Eye irritation | 0/20 (0%) | 1/20 (5%) | ||
| Eyelid oedema | 0/20 (0%) | 1/20 (5%) | ||
| Hypermetropia | 1/20 (5%) | 0/20 (0%) | ||
| Lacrimation increased | 0/20 (0%) | 1/20 (5%) | ||
| Ocular icterus | 0/20 (0%) | 1/20 (5%) | ||
| Retinal degeneration | 0/20 (0%) | 1/20 (5%) | ||
| Retinopathy | 0/20 (0%) | 1/20 (5%) | ||
| Vision blurred | 0/20 (0%) | 1/20 (5%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 15/20 (75%) | 10/20 (50%) | ||
| Abdominal pain upper | 1/20 (5%) | 8/20 (40%) | ||
| Aphthous stomatitis | 0/20 (0%) | 1/20 (5%) | ||
| Cheilitis | 1/20 (5%) | 0/20 (0%) | ||
| Constipation | 1/20 (5%) | 3/20 (15%) | ||
| Dental caries | 2/20 (10%) | 0/20 (0%) | ||
| Diarrhoea | 8/20 (40%) | 9/20 (45%) | ||
| Dry mouth | 1/20 (5%) | 0/20 (0%) | ||
| Dyspepsia | 0/20 (0%) | 2/20 (10%) | ||
| Dysphagia | 0/20 (0%) | 1/20 (5%) | ||
| Enteritis | 3/20 (15%) | 4/20 (20%) | ||
| Flatulence | 1/20 (5%) | 0/20 (0%) | ||
| Gastritis | 1/20 (5%) | 1/20 (5%) | ||
| Gastrooesophageal reflux disease | 0/20 (0%) | 1/20 (5%) | ||
| Gingival bleeding | 0/20 (0%) | 1/20 (5%) | ||
| Gingivitis | 0/20 (0%) | 2/20 (10%) | ||
| Intestinal congestion | 0/20 (0%) | 1/20 (5%) | ||
| Nausea | 2/20 (10%) | 10/20 (50%) | ||
| Odynophagia | 0/20 (0%) | 1/20 (5%) | ||
| Stomatitis | 1/20 (5%) | 0/20 (0%) | ||
| Toothache | 2/20 (10%) | 4/20 (20%) | ||
| Vomiting | 12/20 (60%) | 9/20 (45%) | ||
| General disorders | ||||
| Asthenia | 7/20 (35%) | 8/20 (40%) | ||
| Chest pain | 1/20 (5%) | 3/20 (15%) | ||
| Cyst | 1/20 (5%) | 0/20 (0%) | ||
| Hyperpyrexia | 1/20 (5%) | 3/20 (15%) | ||
| Influenza like illness | 3/20 (15%) | 1/20 (5%) | ||
| Pyrexia | 18/20 (90%) | 16/20 (80%) | ||
| Suprapubic pain | 0/20 (0%) | 1/20 (5%) | ||
| Hepatobiliary disorders | ||||
| Biliary colic | 0/20 (0%) | 1/20 (5%) | ||
| Cholecystitis | 0/20 (0%) | 1/20 (5%) | ||
| Cholelithiasis | 1/20 (5%) | 4/20 (20%) | ||
| Jaundice | 0/20 (0%) | 1/20 (5%) | ||
| Immune system disorders | ||||
| Allergy to plants | 1/20 (5%) | 0/20 (0%) | ||
| Drug hypersensitivity | 0/20 (0%) | 1/20 (5%) | ||
| Food allergy | 0/20 (0%) | 1/20 (5%) | ||
| Hypersensitivity | 1/20 (5%) | 0/20 (0%) | ||
| Infections and infestations | ||||
| Acute tonsillitis | 0/20 (0%) | 1/20 (5%) | ||
| Bacterial infection | 0/20 (0%) | 1/20 (5%) | ||
| Bronchitis | 5/20 (25%) | 5/20 (25%) | ||
| Bronchopneumonia | 0/20 (0%) | 1/20 (5%) | ||
| Catheter related infection | 1/20 (5%) | 0/20 (0%) | ||
| Ear infection | 9/20 (45%) | 2/20 (10%) | ||
| Fungal infection | 2/20 (10%) | 2/20 (10%) | ||
| Gastroenteritis | 10/20 (50%) | 8/20 (40%) | ||
| Gastroenteritis viral | 1/20 (5%) | 0/20 (0%) | ||
| Genital infection female | 0/20 (0%) | 1/20 (5%) | ||
| Herpes simplex | 1/20 (5%) | 0/20 (0%) | ||
| Impetigo | 2/20 (10%) | 1/20 (5%) | ||
| Influenza | 7/20 (35%) | 11/20 (55%) | ||
| Laryngitis | 2/20 (10%) | 1/20 (5%) | ||
| Leptospirosis | 0/20 (0%) | 1/20 (5%) | ||
| Localised infection | 0/20 (0%) | 1/20 (5%) | ||
| Lymphangitis | 0/20 (0%) | 1/20 (5%) | ||
| Nasopharyngitis | 6/20 (30%) | 2/20 (10%) | ||
| Oral candidiasis | 1/20 (5%) | 0/20 (0%) | ||
| Oral herpes | 2/20 (10%) | 2/20 (10%) | ||
| Otitis media | 0/20 (0%) | 1/20 (5%) | ||
| Pharyngitis | 12/20 (60%) | 10/20 (50%) | ||
| Pharyngotonsillitis | 1/20 (5%) | 4/20 (20%) | ||
| Pyoderma | 1/20 (5%) | 0/20 (0%) | ||
| Rhinitis | 17/20 (85%) | 13/20 (65%) | ||
| Sinusitis | 1/20 (5%) | 0/20 (0%) | ||
| Skin infection | 0/20 (0%) | 2/20 (10%) | ||
| Subcutaneous abscess | 1/20 (5%) | 1/20 (5%) | ||
| Tinea versicolour | 0/20 (0%) | 1/20 (5%) | ||
| Tonsillitis | 3/20 (15%) | 5/20 (25%) | ||
| Tooth abscess | 2/20 (10%) | 1/20 (5%) | ||
| Tracheitis | 2/20 (10%) | 2/20 (10%) | ||
| Urinary tract infection | 0/20 (0%) | 2/20 (10%) | ||
| Varicella | 5/20 (25%) | 1/20 (5%) | ||
| Vulvitis | 1/20 (5%) | 0/20 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Arthropod bite | 1/20 (5%) | 1/20 (5%) | ||
| Chest injury | 1/20 (5%) | 0/20 (0%) | ||
| Eye injury | 1/20 (5%) | 0/20 (0%) | ||
| Foreign body trauma | 1/20 (5%) | 0/20 (0%) | ||
| Hand fracture | 2/20 (10%) | 1/20 (5%) | ||
| Head injury | 1/20 (5%) | 1/20 (5%) | ||
| Injury | 1/20 (5%) | 0/20 (0%) | ||
| Joint injury | 0/20 (0%) | 1/20 (5%) | ||
| Joint sprain | 0/20 (0%) | 2/20 (10%) | ||
| Limb injury | 3/20 (15%) | 0/20 (0%) | ||
| Sunburn | 0/20 (0%) | 1/20 (5%) | ||
| Thermal burn | 0/20 (0%) | 2/20 (10%) | ||
| Transfusion reaction | 2/20 (10%) | 1/20 (5%) | ||
| Vertebral injury | 1/20 (5%) | 0/20 (0%) | ||
| Wound | 1/20 (5%) | 1/20 (5%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 1/20 (5%) | 0/20 (0%) | ||
| Beta 2 microglobulin urine increased | 0/20 (0%) | 1/20 (5%) | ||
| Blood bilirubin increased | 0/20 (0%) | 1/20 (5%) | ||
| Blood creatinine increased | 1/20 (5%) | 2/20 (10%) | ||
| Blood folate decreased | 1/20 (5%) | 0/20 (0%) | ||
| Blood homocysteine increased | 0/20 (0%) | 1/20 (5%) | ||
| Creatinine renal clearance decreased | 1/20 (5%) | 0/20 (0%) | ||
| Electrocardiogram QT prolonged | 1/20 (5%) | 0/20 (0%) | ||
| Glomerular filtration rate abnormal | 1/20 (5%) | 0/20 (0%) | ||
| Glucose urine present | 0/20 (0%) | 1/20 (5%) | ||
| Protein C decreased | 0/20 (0%) | 1/20 (5%) | ||
| Transaminases increased | 8/20 (40%) | 2/20 (10%) | ||
| Urinary casts | 1/20 (5%) | 0/20 (0%) | ||
| Urine protein/creatinine ratio increased | 0/20 (0%) | 1/20 (5%) | ||
| Vitamin E decreased | 2/20 (10%) | 4/20 (20%) | ||
| White blood cell count increased | 0/20 (0%) | 1/20 (5%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 0/20 (0%) | 1/20 (5%) | ||
| Glucose tolerance impaired | 1/20 (5%) | 0/20 (0%) | ||
| Hyperinsulinism | 0/20 (0%) | 1/20 (5%) | ||
| Hypozincaemia | 1/20 (5%) | 1/20 (5%) | ||
| Vitamin C deficiency | 1/20 (5%) | 2/20 (10%) | ||
| Zinc deficiency | 3/20 (15%) | 5/20 (25%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 5/20 (25%) | 3/20 (15%) | ||
| Back pain | 3/20 (15%) | 9/20 (45%) | ||
| Bone swelling | 1/20 (5%) | 0/20 (0%) | ||
| Groin pain | 1/20 (5%) | 0/20 (0%) | ||
| Muscle spasms | 0/20 (0%) | 1/20 (5%) | ||
| Musculoskeletal chest pain | 3/20 (15%) | 0/20 (0%) | ||
| Musculoskeletal pain | 0/20 (0%) | 3/20 (15%) | ||
| Myalgia | 1/20 (5%) | 0/20 (0%) | ||
| Neck mass | 0/20 (0%) | 1/20 (5%) | ||
| Neck pain | 1/20 (5%) | 0/20 (0%) | ||
| Pain in extremity | 1/20 (5%) | 2/20 (10%) | ||
| Torticollis | 1/20 (5%) | 3/20 (15%) | ||
| Nervous system disorders | ||||
| Aphonia | 0/20 (0%) | 1/20 (5%) | ||
| Disturbance in attention | 1/20 (5%) | 0/20 (0%) | ||
| Headache | 9/20 (45%) | 12/20 (60%) | ||
| Migraine | 1/20 (5%) | 0/20 (0%) | ||
| Presyncope | 1/20 (5%) | 1/20 (5%) | ||
| Somnolence | 0/20 (0%) | 1/20 (5%) | ||
| Psychiatric disorders | ||||
| Anxiety | 0/20 (0%) | 2/20 (10%) | ||
| Depression | 0/20 (0%) | 1/20 (5%) | ||
| Insomnia | 0/20 (0%) | 2/20 (10%) | ||
| Nervousness | 1/20 (5%) | 0/20 (0%) | ||
| Renal and urinary disorders | ||||
| Haematuria | 1/20 (5%) | 0/20 (0%) | ||
| Nephropathy toxic | 0/20 (0%) | 1/20 (5%) | ||
| Pollakiuria | 0/20 (0%) | 1/20 (5%) | ||
| Proteinuria | 2/20 (10%) | 2/20 (10%) | ||
| Renal colic | 0/20 (0%) | 2/20 (10%) | ||
| Reproductive system and breast disorders | ||||
| Amenorrhoea | 0/20 (0%) | 3/20 (15%) | ||
| Breast discomfort | 0/20 (0%) | 1/20 (5%) | ||
| Dysmenorrhoea | 0/20 (0%) | 4/20 (20%) | ||
| Menorrhagia | 0/20 (0%) | 1/20 (5%) | ||
| Menstrual disorder | 0/20 (0%) | 1/20 (5%) | ||
| Ovarian cyst | 0/20 (0%) | 1/20 (5%) | ||
| Pelvic pain | 0/20 (0%) | 1/20 (5%) | ||
| Polymenorrhoea | 0/20 (0%) | 1/20 (5%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 2/20 (10%) | 0/20 (0%) | ||
| Cough | 18/20 (90%) | 16/20 (80%) | ||
| Dysphonia | 0/20 (0%) | 1/20 (5%) | ||
| Dyspnoea | 1/20 (5%) | 0/20 (0%) | ||
| Epistaxis | 4/20 (20%) | 3/20 (15%) | ||
| Nasal congestion | 0/20 (0%) | 1/20 (5%) | ||
| Pharyngolaryngeal pain | 7/20 (35%) | 9/20 (45%) | ||
| Productive cough | 3/20 (15%) | 0/20 (0%) | ||
| Throat irritation | 1/20 (5%) | 0/20 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Acne | 1/20 (5%) | 1/20 (5%) | ||
| Dermatitis | 1/20 (5%) | 1/20 (5%) | ||
| Eczema | 0/20 (0%) | 2/20 (10%) | ||
| Erythema | 2/20 (10%) | 0/20 (0%) | ||
| Hyperkeratosis | 1/20 (5%) | 0/20 (0%) | ||
| Ingrowing nail | 1/20 (5%) | 0/20 (0%) | ||
| Pityriasis | 1/20 (5%) | 0/20 (0%) | ||
| Pityriasis alba | 1/20 (5%) | 0/20 (0%) | ||
| Psoriasis | 0/20 (0%) | 1/20 (5%) | ||
| Rash | 2/20 (10%) | 1/20 (5%) | ||
| Rash papular | 1/20 (5%) | 0/20 (0%) | ||
| Rash pruritic | 2/20 (10%) | 0/20 (0%) | ||
| Skin discolouration | 1/20 (5%) | 1/20 (5%) | ||
| Skin exfoliation | 0/20 (0%) | 1/20 (5%) | ||
| Urticaria | 2/20 (10%) | 2/20 (10%) | ||
| Vascular disorders | ||||
| Haematoma | 0/20 (0%) | 1/20 (5%) | ||
| Hypotension | 0/20 (0%) | 1/20 (5%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00390858
Other Study ID Numbers:
- CICL670A0106E1
First Posted:
Oct 20, 2006
Last Update Posted:
Mar 20, 2017
Last Verified:
Feb 1, 2017