Nebcin ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
299Cystic fibrosis8

299. Cystic fibrosis


Clinical trials : 1,696 Drugs : 1,644 - (DrugBank : 272) / Drug target genes : 96 - Drug target pathways : 170
No.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
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PhaseCountries
1NCT03066453
(ClinicalTrials.gov)
June 13, 201723/2/2017Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic FibrosisEvaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.Cystic FibrosisDrug: Tobi Inhalant Product;Drug: NebcinUniversity Hospital, LilleNULLTerminated8 YearsN/AAll23Phase 3France
2NCT01337219
(ClinicalTrials.gov)
April 201113/4/2011Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic FibrosisPharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis.Cystic FibrosisDrug: TobramycinErempharmaUniversity of Lyon;Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME);Clininfo;Hospices Civils de LyonRecruiting16 YearsN/ABoth36Phase 1/Phase 2France
3EUCTR2010-023030-23-GB
(EUCTR)
24/12/201023/11/2010Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis (CRITIC) - a Randomised Pharmacokinetic Comparison of Tobramycin in CF - Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis CRITIC-1Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis (CRITIC) - a Randomised Pharmacokinetic Comparison of Tobramycin in CF - Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis CRITIC-1 Cystic fibrosisTrade Name: Nebcin (tobramycin)
Product Name: Tobramycin injection 40mg/1ml
INN or Proposed INN: Tobramcyin
The Univeristy of NottinghamNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
4NCT01288170
(ClinicalTrials.gov)
February 20101/2/2011Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®Cystic FibrosisDrug: Nebcinal Tobi;Drug: Tobi NebcinalErempharmaHopitaux de Lyon;University of LyonRecruiting6 YearsN/ABoth12N/AFrance
5EUCTR2009-013660-39-FR
(EUCTR)
10/09/200927/11/2009Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ®Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® Mucoviscidose
MedDRA version: 12.0;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Nebcinal
INN or Proposed INN: tobramycine
Trade Name: Tobi
Product Name: Tobi
INN or Proposed INN: tobramycine
Erempharma SASNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
6EUCTR2007-003868-22-FR
(EUCTR)
19/03/200820/12/2007ASSESMENT OG EFFICACY AND TOLERABILITY OF INHABLED TOBRAMYCIN VS PLACEBO IN CYSTIC FIBROSIS PATIENTS REVEIVING ANTIBIOTHERAPY FOR 28 DAYS FOR PSEUDOMONAS AERUGINOSA PRIMO COLONISATION. - NEBCINAL 01-07ASSESMENT OG EFFICACY AND TOLERABILITY OF INHABLED TOBRAMYCIN VS PLACEBO IN CYSTIC FIBROSIS PATIENTS REVEIVING ANTIBIOTHERAPY FOR 28 DAYS FOR PSEUDOMONAS AERUGINOSA PRIMO COLONISATION. - NEBCINAL 01-07 Assessment of microbiological efficacy and tolerability of inhaled tobramycin vs placebo in cystic fibrosis patients, primo colonised by Pseudomonas aeruginosa justified inhaled antiobiotherapeutical treatment during 28 days. Product Code: NEB/01-07Laboratoire ErempharmaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
7EUCTR2010-023533-34-FR
(EUCTR)
14/12/2010Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® /Pulmoaid ® chez des patients atteints de mucoviscidose.Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® /Pulmoaid ® chez des patients atteints de mucoviscidose. Mucoviscidose
MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Nebcinal
Product Code: Nebcinal
Trade Name: Tobi
Product Name: Tobi
EREMPHARMA SASNULLNAFemale: yes
Male: yes
Phase 1France
8EUCTR2014-003882-10-FR
(EUCTR)
29/07/2015Evaluation of the efficacy of antibiotic treatments associated with the Nebcine® as intravenous injection only and / or monitoring of aerosols of Tobi® in order to optimize the therapeutic management of exacerbations in patients with cystic fibrosis .Evaluation of the effectiveness of a treatment involving one (or several ) antibiotic (s) with 14-day tobramycin ( Nebcine® ) by intravenous injection versus the same antibiotic treatment (s ) associated with only 5 days of tobramycin ( Nebcine® ) by intravenous injection followed tobramycin aerosol ( Tobi® ) for 9 days in the context of cystic fibrosis mucoviscidosis or cystic fibrosis
MedDRA version: 18.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: NEBCINE
Product Name: NEBCINE
Other descriptive name: TOBRAMYCIN
Trade Name: NEBCINE
Product Name: NEBCINE
Other descriptive name: TOBRAMYCIN
Trade Name: NEBCINE
Product Name: NEBCINE
Other descriptive name: TOBRAMYCIN
Trade Name: NEBCINE
Product Name: NEBCINE
Other descriptive name: TOBRAMYCIN
Trade Name: TOBI
Product Name: TOBI
Other descriptive name: TOBRAMYCIN
CHRU de LilleNULLNAFemale: yes
Male: yes
Phase 2France