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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002318-22 | EudraCT Number |
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This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIP (Tobramycin Inhalation Powder) | Experimental | Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment. |
|
| Placebo | Placebo Comparator | Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.), in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobramycin Inhalation Powder | Drug | Tobramycin Inhalation Powder as produced by a modified manufacturing process TIP. TIP was provided in hard capsules each containing 28 mg active ingredient (tobramycin); Capsules were packaged in blister cards and administered by the T-326 Inhaler. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) | Relative change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model. ITT Patients with missing or unacceptable Day 29 spirometry measurements had their primary endpoint data imputed with zero. BSL = Baseline, defined as the latest measurement prior to the first dosing of study medication - Relative change = 100 * (value - baseline) / baseline There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses. | Baseline, Day 29 |
| Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29) | Absolute change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model. In the adjusted analysis model: response = treatment + screening FEV1 % predicted (<50 and >=50) + age (<13 and >=13) + error. Significance for the FEV1 % predicted is reached for p-values <= 0.05. There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses. | Baseline, Day 29 |
| Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier | Relative change in percentage predicted FEV1 without outlier (outliers with respect to FEV1 values and PK data), in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model. | Baseline, Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to End of Dosing (Day 29) and to the End of Off-cycle Period (Day 57) | Results of statistical analysis were calculated from an ANOVA model. Baseline is defined as the latest measurement prior to the first dosing of study medication. Response (percentage change) = treatment + Screening FEV1 percentage predicted (<50 and >=50) + age (<13 and >=13) + error |
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Inclusion Criteria:
Written informed consent given by adults or by the parents/legal guardian in combination with the patient's assent, if capable of assenting, before any assessment was performed
Confirmed diagnosis of Cystic Fibrosis (CF) by the presence of one or more clinical features of CF in addition to:
Forced Expiratory Volume in one second (FEV1) at screening must have been ≥25% and ≤80% of normal predicted values for age, sex, and height based on Knudson criteria
P. aeruginosa must have been present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/deep-throat cough swab culture at the screening visit
Able to expectorate a sputum sample or provide a deep throat cough swab at screening
Able to comply with all protocol requirements
Use of an effective means of contraception in females of childbearing potential
Clinically stable in the opinion of the investigator to be treated according to this protocol
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 | Pleven | Bulgaria | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23672633 | Derived | Galeva I, Konstan MW, Higgins M, Angyalosi G, Brockhaus F, Piggott S, Thomas K, Chuchalin AG. Tobramycin inhalation powder manufactured by improved process in cystic fibrosis: the randomized EDIT trial. Curr Med Res Opin. 2013 Aug;29(8):947-56. doi: 10.1185/03007995.2013.805122. Epub 2013 Jun 5. |
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Although 32 patients were randomized to the TIP group and 30 to the Placebo group, the ITT population included 2 patients allocated to the TIP group but received placebo due to Investigator error during the drug dispensation process. The safety population contained 30 patients who were treated with TIP and 32 patients who were treated with placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | TIP (Tobramycin Inhalation Powder) | Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Placebo inhalation powder consisting of the excipients used for TIP. Placebo was provided in hard capsules, containing 20 mg placebo powder, which were packaged in blister cards, matching in appearance to TIP. Capsules were administered by the T-326 Inhaler. |
|
| Baseline, Day 29, Day 57 |
| Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent. (FEF25-75%) Predicted to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) | FEF25-75: Forced expiratory flow rate over 25% to 75% of vital capacity For FEF25-75 percentage predicted the relative change is analyzed. If screening FEV1 percentage predicted is missing, it will be imputed by the baseline value. | Baseline, Day 29, Day 57 |
| Absolute Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) in Sputum Pseudomonas Aeruginosa Density (log10 Colony Forming Units(CFU) Per Gram Sputum) | P. aeruginosa sputum density refers to overall density, defined as the sum of biotypes (mucoid, dry and small colony variant). If sub-isolates exist for CFU biotype mucoid or dry, then the sum of sub-isolates is analyzed. | Baseline, Day 29, Day 57 |
| Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) of Pseudomonas Aeruginosa Minimum Inhibitory Concentration (MIC) | Maximum MIC values from all biotypes were used. Absolute values and changes in tobramycin MIC for P. aeruginosa from baseline are summarized by biotype. Overall, a high variability of MIC was observed within each treatment group. For the maximum of all biotypes, large differences in mean changes from baseline at Day 29 were observed between the TIP group and the placebo group. | Baseline, Day 29, Day 57 |
| Shift From Baseline in Laboratory Parameters to Above Upper/Lower Limit of Normal | Hematology values shift from baseline to above upper/below lower limit of normal at any time post-baseline. Biochemistry values shift from baseline to above upper/below lower limit of normal at any time post-baseline. | Baseline, Study completion |
| Percentage of Participants With Adverse Events (AEs) | Adverse Events (AEs) (on and off treatment) regardless of study relationship by primary system organ and treatment group. Primary system organ classes are sorted in descending order of frequency in the TIP treatment group. A patient with more than one AE within a primary system organ class is counted only once for that class. | First administration of study drug, study completion |
| Percentage of Participants With Serious Adverse Events (SAEs) | Serious Adverse Events (on and off treatment) by preferred term and treatment group. Preferred terms are sorted in descending order of frequency in the TIP treatment group. A patient with multiple occurrences of the same preferred term is counted only once in the preferred term. | Time of consent, 4 weeks after study completion |
| Acute Change in Airways Reactivity (FEV1 Percent Predicted) From Pre-dose to 30 Minutes After Completion of First Dose of Study Drug | Relative change = 100 * (30-m-post-dose - pre-dose)/pre-dose assessed by the number and percentage of patients with a decrease of ≥20 % in FEV1 % predicted from pre dose to 30 minutes post dose. Day 1 is the scheduled visit of first study drug administration. | Day 1, Day 29 |
| Tobramycin Serum Concentration | Descriptive statistics of serum and sputum concentrations per scheduled sampling time. Detectable concentration values at pre-dose on Day 1 were excluded from the analysis. | Pre-dose, 0 - 1 hour post-dose, 1 -2 hours post-dose, 2 - 6 hours post-dose |
| Plovdiv |
| Bulgaria |
| Novartis Investigative Site | Sofia | Bulgaria |
| Novartis Investigative Site | Varna | Bulgaria |
| Novartis Investigative Site | Alexandria | Egypt |
| Novartis Investigative Site | Giza | Egypt |
| Novartis Investigative Site | Tallinn | Estonia |
| Novartis Investigative Site | Tartu | Estonia |
| Novartis Investigative Site | Chandigarh | India |
| Novartis Investigative Site | Hyderabad | India |
| Novartis Investigative Site | New Delhi | India |
| Novartis Investigative Site | Vellore | India |
| Novartis Investigative Site | Riga | Latvia |
| Novartis Investigative Site | Kaunas | Lithuania |
| Novartis Investigative Site | Vilnius | Lithuania |
| Novartis Investigative Site | Bucharest | Romania |
| Novartis Investigative Site | Timișoara | Romania |
| Novartis Investigative Site | Kazan' | Russia |
| Novartis Investigative Site | Moscow | Russia |
| Novartis Investigative Site | Saint Petersburg | Russia |
| Novartis Investigative Site | Samara | Russia |
| Novartis Investigative Site | Voronezh | Russia |
| Novartis Investigator Site | Yaroslavi | Russia |
| Novartis Investigative Site | Durban | South Africa |
Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TIP (Tobramycin Inhalation Powder) | Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment. |
| BG001 | Placebo | Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Forced Expiratory Volume in one second (FEV1) percentage predicted |
| Mean | Standard Deviation | Percentage |
| ||||||||||||||
| Baseline P. aeruginosa sputum density |
| Mean | Standard Deviation | Log10 CFU (colony forming unit) |
|
| 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 | Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) | Relative change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model. ITT Patients with missing or unacceptable Day 29 spirometry measurements had their primary endpoint data imputed with zero. BSL = Baseline, defined as the latest measurement prior to the first dosing of study medication - Relative change = 100 * (value - baseline) / baseline There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses. | ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded. | Posted | Least Squares Mean | Standard Error | change in percentage | Baseline, Day 29 |
|
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| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to End of Dosing (Day 29) and to the End of Off-cycle Period (Day 57) | Results of statistical analysis were calculated from an ANOVA model. Baseline is defined as the latest measurement prior to the first dosing of study medication. Response (percentage change) = treatment + Screening FEV1 percentage predicted (<50 and >=50) + age (<13 and >=13) + error | Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. | Posted | Mean | Standard Error | percentage change | Baseline, Day 29, Day 57 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent. (FEF25-75%) Predicted to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) | FEF25-75: Forced expiratory flow rate over 25% to 75% of vital capacity For FEF25-75 percentage predicted the relative change is analyzed. If screening FEV1 percentage predicted is missing, it will be imputed by the baseline value. | Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Day 29, Day 57 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) in Sputum Pseudomonas Aeruginosa Density (log10 Colony Forming Units(CFU) Per Gram Sputum) | P. aeruginosa sputum density refers to overall density, defined as the sum of biotypes (mucoid, dry and small colony variant). If sub-isolates exist for CFU biotype mucoid or dry, then the sum of sub-isolates is analyzed. | Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. | Posted | Mean | Standard Error | Log10 CFU (colony forming unit) | Baseline, Day 29, Day 57 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Dosing (Day 29) and End of Off-cycle Period (Day 57) of Pseudomonas Aeruginosa Minimum Inhibitory Concentration (MIC) | Maximum MIC values from all biotypes were used. Absolute values and changes in tobramycin MIC for P. aeruginosa from baseline are summarized by biotype. Overall, a high variability of MIC was observed within each treatment group. For the maximum of all biotypes, large differences in mean changes from baseline at Day 29 were observed between the TIP group and the placebo group. | Intent-to-treat (ITT) population: All randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. | Posted | Mean | Standard Deviation | μg/mL | Baseline, Day 29, Day 57 |
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| Secondary | Shift From Baseline in Laboratory Parameters to Above Upper/Lower Limit of Normal | Hematology values shift from baseline to above upper/below lower limit of normal at any time post-baseline. Biochemistry values shift from baseline to above upper/below lower limit of normal at any time post-baseline. | Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received. | Posted | Number | percentage of participants at risk | Baseline, Study completion |
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| Secondary | Percentage of Participants With Adverse Events (AEs) | Adverse Events (AEs) (on and off treatment) regardless of study relationship by primary system organ and treatment group. Primary system organ classes are sorted in descending order of frequency in the TIP treatment group. A patient with more than one AE within a primary system organ class is counted only once for that class. | Safety population: All randomized patients who received at least one dose of study drug.In all safety analyses patients were analyzed according to the treatment received | Posted | Number | Percentage of participants | First administration of study drug, study completion |
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| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) | Serious Adverse Events (on and off treatment) by preferred term and treatment group. Preferred terms are sorted in descending order of frequency in the TIP treatment group. A patient with multiple occurrences of the same preferred term is counted only once in the preferred term. | Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received. | Posted | Number | percentage of participants | Time of consent, 4 weeks after study completion |
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| Secondary | Acute Change in Airways Reactivity (FEV1 Percent Predicted) From Pre-dose to 30 Minutes After Completion of First Dose of Study Drug | Relative change = 100 * (30-m-post-dose - pre-dose)/pre-dose assessed by the number and percentage of patients with a decrease of ≥20 % in FEV1 % predicted from pre dose to 30 minutes post dose. Day 1 is the scheduled visit of first study drug administration. | Safety population: All randomized patients who received at least one dose of study drug.In all safety analyses patients were analyzed according to the treatment received. | Posted | Number | Percentage of participants | Day 1, Day 29 |
|
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| Secondary | Tobramycin Serum Concentration | Descriptive statistics of serum and sputum concentrations per scheduled sampling time. Detectable concentration values at pre-dose on Day 1 were excluded from the analysis. | Safety population: All randomized patients who received at least one dose of study drug. In all safety analyses patients were analyzed according to the treatment received. This measures the concentration of active substance in the body at different time-point to evaluate there is abnormal accumulation of active substance. Not for Placebo Patients. | Posted | Mean | Standard Deviation | μg/mL | Pre-dose, 0 - 1 hour post-dose, 1 -2 hours post-dose, 2 - 6 hours post-dose |
|
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| Primary | Pre-planned Sensitivity Analysis: Absolute Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent (%) Predicted to End of Dosing (Day 29) | Absolute change in percentage predicted FEV1 in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model. In the adjusted analysis model: response = treatment + screening FEV1 % predicted (<50 and >=50) + age (<13 and >=13) + error. Significance for the FEV1 % predicted is reached for p-values <= 0.05. There were 3 patients who had no screening nor baseline values (due to inadequate spirometry) and so were excluded from all change from baseline analyses. | ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded. | Posted | Least Squares Mean | Standard Error | change in percentage | Baseline, Day 29 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Post-hoc: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to End of Dosing (Day 29) Without Outlier | Relative change in percentage predicted FEV1 without outlier (outliers with respect to FEV1 values and PK data), in the Intent-to-treat (ITT), modified ITT (mITT) and Observed cases in the ITT populations were calculated from an adjusted analysis ANOVA model. | ITT: All randomized patients (pts) received at least one dose of study drug. Missing or unacceptable Day 29 spirometry test -change from baseline FEV1 % predicted imputed using last available post-baseline value or 0. mITT: Pts with unacceptable FEV1 measurements excluded. Observed cases: Pts with missing or unacceptable FEV1 measurements excluded. | Posted | Least Squares Mean | Standard Error | change in percentage | Baseline, Day 29 |
|
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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 | TIP (Tobramycin Inhalation Powder) | Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment. | 0 | 30 | 4 | 30 | ||
| EG001 | Placebo | Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). | 2 | 32 | 6 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 10.X | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 10.X | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 10.X | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 10.X | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 10.X | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.X | Systematic Assessment |
|
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 or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
Not provided
Not provided
| >= 13 years |
|
| Male |
|
| Parts analyzed: Observed Cases in ITT Pop (25, 27) |
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