Study to Demonstrate the Efficacy and Safety of Propranol... | NCT01056341 | Trialant
NCT01056341
Sponsor
Pierre Fabre Dermatology
Status
Completed
Last Update Posted
Dec 10, 2015Estimated
Enrollment
512Actual
Phase
Phase 2Phase 3
Conditions
Infantile Hemangioma
Interventions
Propranolol
Placebo
Countries
United States
Australia
Canada
Czechia
France
Germany
Hungary
Italy
Lithuania
Mexico
New Zealand
Peru
Poland
Romania
Russia
Spain
Protocol Section
Identification Module
NCT ID
NCT01056341
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V00400 SB 201 Study
Secondary IDs
Not provided
Brief Title
Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy
Official Title
A Randomised, Controlled, Multidose, Multicentre, Adaptive Phase II/III Study in Infants With Proliferating Infantile Hemangiomas (IHs) Requiring Systemic Therapy to Compare 4 Regimens of Propranolol (1 or 3 mg/kg/Day for 3 or 6 Months) to Placebo (Double Blind).
Acronym
Not provided
Organization
Pierre Fabre DermatologyINDUSTRY
Status Module
Record Verification Date
Nov 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 2010
Primary Completion Date
May 2012Actual
Completion Date
Nov 2013Actual
First Submitted Date
Jan 24, 2010
First Submission Date that Met QC Criteria
Jan 24, 2010
First Posted Date
Jan 26, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 9, 2014
Results First Submitted that Met QC Criteria
May 21, 2014
Results First Posted Date
Jun 24, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 27, 2013
Certification/Extension First Submitted that Passed QC Review
Mar 28, 2013
Certification/Extension First Posted Date
Apr 4, 2013Estimated
Last Update Submitted Date
Nov 12, 2015
Last Update Posted Date
Dec 10, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Pierre Fabre DermatologyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.
Detailed Description
Primary objective The primary objective of this study is to identify the appropriate dose and duration of propranolol treatment and demonstrate its superiority over placebo based on the complete/nearly complete resolution of target IH at W24.
Conditions Module
Conditions
Infantile Hemangioma
Keywords
Infantile Hemangioma
Propranolol
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
512Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Propranolol oral solution
Experimental
Drug: Propranolol
Placebo
Placebo Comparator
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Propranolol
Drug
Propranolol (1 or 3 mg/kg/day for 3 or 6 months)
Propranolol oral solution
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs.
6 months
Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs.
6 months
Secondary Outcomes
Measure
Description
Time Frame
Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48.
Time to first sustained improvement based on centralized qualitative assessments of paired patient-visits
6 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Proliferating IH (target hemangioma) requiring systemic therapy anywhere on the body except on the diaper area with largest diameter of at least 1.5 cm
Exclusion Criteria:
- The patient presents with one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycaemia (< 40 mg/dl or at risk); untreated phaeochromocytoma; hypotension (< 50/30 mmHg); second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia (< 80 bpm); severe peripheral arterial circulatory disturbances; Raynaud's phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal's angina; documented PHACES syndrome with central nervous system involvement
The patient has previously been treated for IH, including any surgical and/or medical procedures (e.g. laser therapy)
The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers
One or more of the following types of IH are present:
Life-threatening IH
Function-threatening IH (e.g. those causing impairment of vision, respiratory compromise caused by airway lesions, etc.)
Ulcerated IH (whatever the localisation) with pain and lack of response to simple wound care measures
The patient was born prematurely and has not yet reached his/her term equivalent age (e.g. an infant born 2 months prematurely cannot be included before the age of 2 months)
Leaute-Labreze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taieb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819. No abstract available.
Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taieb A, Leaute-Labreze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
512 patients were included in the study (informed Consent Form signed). Among these 510 patients, 460 were randomized and 52 were screen failure
At least one inclusion criterion not met in 26 cases
Parent's decision in 12 cases
Other reasons in 15 cases.
One patient was not included for two reasons (Parent's decision and other reason)
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo: Treatment with placebo for 6 months
FG001
Propranolol 1mg/kg/d 3 Months
Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
Leaute-Labreze C, Hoeger P, Mazereeuw-Hautier J, Guibaud L, Baselga E, Posiunas G, Phillips RJ, Caceres H, Lopez Gutierrez JC, Ballona R, Friedlander SF, Powell J, Perek D, Metz B, Barbarot S, Maruani A, Szalai ZZ, Krol A, Boccara O, Foelster-Holst R, Febrer Bosch MI, Su J, Buckova H, Torrelo A, Cambazard F, Grantzow R, Wargon O, Wyrzykowski D, Roessler J, Bernabeu-Wittel J, Valencia AM, Przewratil P, Glick S, Pope E, Birchall N, Benjamin L, Mancini AJ, Vabres P, Souteyrand P, Frieden IJ, Berul CI, Mehta CR, Prey S, Boralevi F, Morgan CC, Heritier S, Delarue A, Voisard JJ. A randomized, controlled trial of oral propranolol in infantile hemangioma. N Engl J Med. 2015 Feb 19;372(8):735-46. doi: 10.1056/NEJMoa1404710.
FG002
Propranolol 1 mg/kg/d 6 Months
Propranolol oral solution 1mg/kg/day for 6 months
FG003
Propranolol 3 mg/kg/d 3 Months
Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
FG004
Propranolol 3 mg/kg/d 6 Months
Propranolol oral solution 3mg/kg/day for 6 months
FG00055 subjects
FG00199 subjects
FG002103 subjects
FG003101 subjects
FG004102 subjects
Interim Analysis
FG00025 subjects
FG00141 subjects
FG00241 subjects
FG00340 subjects
FG00443 subjects
COMPLETED
FG00019 subjects
FG00163 subjects
FG00288 subjects
FG00365 subjects
FG00488 subjects
NOT COMPLETED
FG00036 subjects
FG00136 subjects
FG00215 subjects
FG00336 subjects
FG00414 subjects
Type
Comment
Reasons
Treatment Intolerance
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
Lack of Efficacy
FG00032 subjects
FG00130 subjects
FG0027 subjects
FG00325 subjects
FG004
Other reasons
FG0004 subjects
FG0014 subjects
FG0028 subjects
FG0039 subjects
FG004
Among the 460 randomized patients, 4 were not treated: 2 because of parent(s)'/guardian's decision (1 in 1mg/kg/day 6 months arm,1 in 3 mg/kg/day 3 months arm), 2 because of absence of adequate treatment on site (1 in 1 mg/kg/day 3 months arm and 1 in 3mg/kg/day 6 months arm).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo: Treatment with placebo for 6 months
BG001
Propranolol 1mg/kg/d 3 Months
Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
BG002
Propranolol 1 mg/kg/d 6 Months
Propranolol oral solution 1mg/kg/day for 6 months
BG003
Propranolol 3 mg/kg/d 3 Months
Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
BG004
Propranolol 3 mg/kg/d 6 Months
Propranolol oral solution 3mg/kg/day for 6 months
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00055
BG00198
BG002102
BG003100
BG004101
BG005456
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
DAYS
Title
Denominators
Categories
Title
Measurements
BG000103.91± 31.06
BG001103.58± 33.07
BG002102.65± 30.12
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00038
BG00168
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0006
BG00113
BG002
Infantile hemangioma localization
Number
participants
Title
Denominators
Categories
FACE
Title
Measurements
BG00040
BG00171
BG002
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
Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs.
Among the 190 first randomized patients who entered the stage 1 of the study, 2 patients were not treated because of parent'/legal guardian's decision: 1 in the 1mg/kg/day 6 months arm and 1 in the 3 mg/kg/day 3 months arm.
Posted
Number
percentage of participants
6 months
ID
Title
Description
OG000
Placebo
Placebo: Treatment with placebo for 6 months
OG001
Propranolol 1mg/kg/d 3 Months
Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
OG002
Propranolol 1 mg/kg/d 6 Months
Propranolol oral solution 1mg/kg/day for 6 months
OG003
Propranolol 3 mg/kg/d 3 Months
Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
OG004
Propranolol 3 mg/kg/d 6 Months
Propranolol oral solution 3mg/kg/day for 6 months
Units
Counts
Participants
OG00025
OG00141
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG0008.0
OG0019.8
OG00237.5
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
The interim analysis was carried out after the first 188 patients have completed their W24 visit or been withdrawn prematurely from study therapy. For each propranolol arm, individual hypotheses H0,i: θi≤0
One-sided Z-tests
One-sided Z-tests for proportions (contrasts tests on placebo) with pooled variance
< 0.0001
P-value not adjusted for multiplicity. An Independent Committee conducted this analysis to determine the most efficacious of all arms with a good safety profile.
P-value linked to the 3 mg/kg/day 6 months selected arm .
No
Primary
Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs.
After the interim analysis results, the Independent Committee recommendations was to continue the trial with the 3 mg/kg/day6 months arm and the placebo arm. 55 randomized and treated patients in the placebo arm and 102 randomized patients in the 3 mg/kg/day6 months arm,1 was not treated because no unit of the assigned treatment available on site.
Posted
Number
percentage of participants
6 months
ID
Title
Description
OG000
Placebo
Placebo: Treatment with placebo for 6 months
OG001
Propranolol 3mg/kg/d 6 Months
Propranolol 3 mg/kg/day for 6 months
Units
Counts
Participants
OG000
Secondary
Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48.
Time to first sustained improvement based on centralized qualitative assessments of paired patient-visits
Not Posted
6 months
Time Frame
Safety evaluation of the four regimens of oral propranolol (versus placebo) over a 24-week treatment period. Safety evaluation of the four previous regimens of oral propranolol (versus placebo) over a follow up period of 72 weeks (up to 96 weeks).
Description
Safety population included all participants who received at least one dose of Propranolol (1 or 3mg/kg/day for 3 or 6 months) or placebo.
Among the 456 treated patients, 65 were withdrawn during treatment period:22 in placebo arm, 13 in 1mg/kg/day 3months arm, 11 in 1mg/kg/day 6months arm, 13 in 3mg/kg/day 3months arm, 6 in 3mg/kg/day 6months arm.
Propranolol hydrochloride oral solution 3mg/kg/day for 6 months
5
101
96
101
EG005
W72-follow-up Period of ex Placebo Group-safety Set
72-week follow-up period without study treatment administration
5
33
27
33
EG006
W72-follow-up Period of ex 1mg/kg/d 3 Months Group-safety Set
72-week follow-up period without study treatment administration
6
85
66
85
EG007
W72-follow-up Period of ex 1mg/kg/d 6 Months Group-safety Set
72-week follow-up period without study treatment administration
5
91
70
91
EG008
W72-follow-up Period of ex 3mg/kg/d 3 Months Group-safety Set
72-week follow-up period without study treatment administration
5
87
65
87
EG009
W72-follow-up Period of ex 3mg/kg/d 6 Months Group-safety Set
72-week follow-up period without study treatment administration
7
95
75
95
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Apathy
Psychiatric disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG0031 affected100 at risk
EG0041 affected101 at risk
EG0050 affected33 at risk
EG0060 affected85 at risk
EG0070 affected91 at risk
EG0080 affected87 at risk
EG0090 affected95 at risk
Atrioventricular block second degree
Cardiac disorders
EG0000 affected55 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Bradycardia
Cardiac disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Bronchiolitis
Infections and infestations
EG0000 affected55 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Bronchitis
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Bronchopneumonia
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Condition aggravated
General disorders
EG0002 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Cyanosis
Cardiac disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Cystitis
Infections and infestations
EG0000 affected55 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Drug ineffective
General disorders
EG0001 affected55 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
Enterocolitis
Gastrointestinal disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Epilepsy
Nervous system disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Gastroenteritis
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Traumatic brain injury
Injury, poisoning and procedural complications
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Ileostomy closure
Surgical and medical procedures
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Inguinal hernia repair
Surgical and medical procedures
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
Pyelonephritis
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Pyrexia
General disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Rotavirus infection
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Viraemia
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
cataract operation
Surgical and medical procedures
EG0000 affected55 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
dehydration
Metabolism and nutrition disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
surgery
Surgical and medical procedures
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Finger amputation
Surgical and medical procedures
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
hip surgery
Surgical and medical procedures
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
hospitalisation
Surgical and medical procedures
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
scrotal operation
Surgical and medical procedures
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
hip dysplasia
Congenital, familial and genetic disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
asphyxia
Respiratory, thoracic and mediastinal disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
asthma
Respiratory, thoracic and mediastinal disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
cough
Respiratory, thoracic and mediastinal disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
convulsion
Nervous system disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
febrile convulsion
Nervous system disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
inflammation
General disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
hyperthermia
General disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
ketoacidosis
Metabolism and nutrition disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
type 1 diabetes mellitus
Metabolism and nutrition disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
respiratory tract infection viral
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
ear infection
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
gastroenteritis rotavirus
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
nasopharyngitis
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
otitis media acute
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
respiratory syncytial virus infection
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
tonsillitis
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
pneumonia
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bronchiolitis
Infections and infestations
EG0003 affected55 at risk
EG0015 affected98 at risk
EG0027 affected102 at risk
EG0035 affected100 at risk
EG0049 affected101 at risk
EG0052 affected33 at risk
EG0066 affected85 at risk
EG0074 affected91 at risk
EG0089 affected87 at risk
EG00911 affected95 at risk
Bronchitis
Infections and infestations
EG0001 affected55 at risk
EG0015 affected98 at risk
EG0028 affected102 at risk
EG003
Conjunctivitis
Eye disorders
EG0002 affected55 at risk
EG0014 affected98 at risk
EG0028 affected102 at risk
EG003
Constipation
Gastrointestinal disorders
EG0001 affected55 at risk
EG0019 affected98 at risk
EG0026 affected102 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
EG0004 affected55 at risk
EG00114 affected98 at risk
EG00218 affected102 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
EG0002 affected55 at risk
EG0014 affected98 at risk
EG0025 affected102 at risk
EG003
Diarrhea
Gastrointestinal disorders
EG0004 affected55 at risk
EG00116 affected98 at risk
EG00214 affected102 at risk
EG003
Ear infection
Infections and infestations
EG0000 affected55 at risk
EG0017 affected98 at risk
EG0026 affected102 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
EG0001 affected55 at risk
EG0018 affected98 at risk
EG0024 affected102 at risk
EG003
Gastroenteritis
Infections and infestations
EG0002 affected55 at risk
EG0012 affected98 at risk
EG0025 affected102 at risk
EG003
Insomnia
Psychiatric disorders
EG0003 affected55 at risk
EG0013 affected98 at risk
EG0021 affected102 at risk
EG003
Irritability
General disorders
EG0003 affected55 at risk
EG0015 affected98 at risk
EG0026 affected102 at risk
EG003
Middle insomnia
Psychiatric disorders
EG0003 affected55 at risk
EG0016 affected98 at risk
EG0024 affected102 at risk
EG003
Nasopharyngitis
Infections and infestations
EG00010 affected55 at risk
EG00129 affected98 at risk
EG00221 affected102 at risk
EG003
Peripheral coldness
Vascular disorders
EG0001 affected55 at risk
EG0018 affected98 at risk
EG00210 affected102 at risk
EG003
Pyrexia
General disorders
EG0006 affected55 at risk
EG00121 affected98 at risk
EG00224 affected102 at risk
EG003
Rhinitis
Infections and infestations
EG0005 affected55 at risk
EG00113 affected98 at risk
EG00213 affected102 at risk
EG003
Rhinorrhea
Respiratory, thoracic and mediastinal disorders
EG0002 affected55 at risk
EG0013 affected98 at risk
EG0023 affected102 at risk
EG003
Sleep disorder
Psychiatric disorders
EG0001 affected55 at risk
EG00112 affected98 at risk
EG0026 affected102 at risk
EG003
Somnolence
Nervous system disorders
EG0001 affected55 at risk
EG0016 affected98 at risk
EG0024 affected102 at risk
EG003
Teething
Gastrointestinal disorders
EG0006 affected55 at risk
EG00119 affected98 at risk
EG00223 affected102 at risk
EG003
Toothhache
Gastrointestinal disorders
EG0002 affected55 at risk
EG0015 affected98 at risk
EG0022 affected102 at risk
EG003
Upper respiratory tract infection
Infections and infestations
EG0004 affected55 at risk
EG0016 affected98 at risk
EG00213 affected102 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
EG0002 affected55 at risk
EG0017 affected98 at risk
EG0029 affected102 at risk
EG003
Vomiting
Gastrointestinal disorders
EG0003 affected55 at risk
EG00116 affected98 at risk
EG00213 affected102 at risk
EG003
nasal congestion
Respiratory, thoracic and mediastinal disorders
EG0001 affected55 at risk
EG0013 affected98 at risk
EG0026 affected102 at risk
EG003
asthma
Respiratory, thoracic and mediastinal disorders
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
hypotonia
Nervous system disorders
EG0000 affected55 at risk
EG0011 affected98 at risk
EG0021 affected102 at risk
EG003
condition aggravated
General disorders
EG0000 affected55 at risk
EG0013 affected98 at risk
EG0021 affected102 at risk
EG003
agitation
Psychiatric disorders
EG0000 affected55 at risk
EG0011 affected98 at risk
EG0026 affected102 at risk
EG003
gingival pain
Gastrointestinal disorders
EG0001 affected55 at risk
EG0013 affected98 at risk
EG0020 affected102 at risk
EG003
dermatitis atopic
Skin and subcutaneous tissue disorders
EG0001 affected55 at risk
EG0012 affected98 at risk
EG0021 affected102 at risk
EG003
decreased appetite
Metabolism and nutrition disorders
EG0001 affected55 at risk
EG0015 affected98 at risk
EG0023 affected102 at risk
EG003
tonsillitis
Infections and infestations
EG0000 affected55 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
pharyngitis
Infections and infestations
EG0000 affected55 at risk
EG0014 affected98 at risk
EG0023 affected102 at risk
EG003
otite media
Infections and infestations
EG0000 affected55 at risk
EG0011 affected98 at risk
EG0021 affected102 at risk
EG003
influenza
Infections and infestations
EG0001 affected55 at risk
EG0011 affected98 at risk
EG0023 affected102 at risk
EG003
varicella
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
roseola
Infections and infestations
EG0001 affected55 at risk
EG0011 affected98 at risk
EG0020 affected102 at risk
EG003
hand-foot-and-mouth disease
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
acute tonsillitis
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
croup infectious
Infections and infestations
EG0000 affected55 at risk
EG0011 affected98 at risk
EG0021 affected102 at risk
EG003
eye infection
Infections and infestations
EG0001 affected55 at risk
EG0010 affected98 at risk
EG0021 affected102 at risk
EG003
gastroenteritis viral
Infections and infestations
EG0000 affected55 at risk
EG0010 affected98 at risk
EG0020 affected102 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The investigators can reserve the right to publish or present study data; provided that the sponsor reviews the abstract or manuscript at least 60 days prior to the expected date of submission to the intended publisher or planned presentation.
Publication of study results by each site shall be made only after completion and finalisation of the study by all sites and first publication by the Sponsor.
Point of Contact
Title
Organization
Phone
Extension
Email
Dr. Jean-Jacques VOISARD - General Manager -
Pierre Fabre Dermatologie
+33 5 63 58 88 00
jean.jacques.voisard@pierre-fabre.com
ID
Term
D018324
Hemangioma, Capillary
Ancestor Terms
ID
Term
D006391
Hemangioma
D009383
Neoplasms, Vascular Tissue
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D011433
Propranolol
Ancestor Terms
ID
Term
D050198
Phenoxypropanolamines
D011412
Propanolamines
D000605
Amino Alcohols
D000438
Alcohols
D009930
Organic Chemicals
D020005
Propanols
D000588
Amines
D009281
Naphthalenes
D011084
Polycyclic Aromatic Hydrocarbons
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D011083
Polycyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
9 subjects
5 subjects
107.53
± 30.14
BG004101.63± 31.00
BG005103.85± 31.02
70
BG00379
BG00470
BG005325
Male
BG00017
BG00130
BG00232
BG00321
BG00431
BG005131
13
BG00311
BG00410
BG00553
Spain
Title
Measurements
BG0005
BG0019
BG00214
BG00317
BG00414
BG00559
Lithuania
Title
Measurements
BG0001
BG0017
BG0024
BG0031
BG0045
BG00518
Russian Federation
Title
Measurements
BG0000
BG0011
BG0020
BG0031
BG0041
BG0053
Italy
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0041
BG0052
France
Title
Measurements
BG00021
BG00125
BG00218
BG00322
BG00428
BG005114
Czech Republic
Title
Measurements
BG0002
BG0011
BG0023
BG0031
BG0041
BG0058
Hungary
Title
Measurements
BG0001
BG0012
BG0024
BG0032
BG0042
BG00511
Mexico
Title
Measurements
BG0000
BG0012
BG0020
BG0033
BG0040
BG0055
Canada
Title
Measurements
BG0002
BG0015
BG0026
BG0033
BG0042
BG00518
Poland
Title
Measurements
BG0004
BG0014
BG0026
BG0038
BG0044
BG00526
Romania
Title
Measurements
BG0002
BG0012
BG0021
BG0030
BG0042
BG0057
Peru
Title
Measurements
BG0001
BG0015
BG0029
BG0038
BG00412
BG00535
Australia
Title
Measurements
BG0001
BG0015
BG00214
BG0035
BG0047
BG00532
Germany
Title
Measurements
BG0008
BG00117
BG0029
BG00317
BG0049
BG00560
New Zealand
Title
Measurements
BG0000
BG0010
BG0021
BG0031
BG0043
BG0055
72
BG00364
BG00471
BG005318
NONE FACE
Title
Measurements
BG00015
BG00127
BG00230
BG00336
BG00430
BG005138
39
OG00443
7.7
OG00462.8
Superiority or Other
55
OG001101
Title
Denominators
Categories
Title
Measurements
OG0003.6
OG00160.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The objective is to test the superiority of the selected arm using the approach of Posch et al.
The primary analysis was performed on the intent-to-treat population: all treated patients in Stage 1 and all treated patients in stage 2 randomized to placebo or the selected arm.
combination tests
Superiority was tested using the closed testing procedure and combination tests for all intersection hypotheses using Simes' adjustment.
< 0.0001
The methodology used guaranteed that the familywise type I error rate was below the nominal one-sided significance level of 0.005.