Study Evaluating the Efficacy and Safety of Pantoprazole... | NCT00365300

NCT00365300

Status Module

Sponsor/Collaborators Module

Oversight Module

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No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Pantoprazole	Active Comparator		Drug: pantoprazole
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
pantoprazole	Drug		Pantoprazole
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients Withdrawn From Study Due to Lack of Efficacy.	Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician's judgment.	4 weeks double-blind

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

References Module

No data available

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IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pantoprazole Sodium Granules	Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Pantoprazole Sodium Granules	Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
BG001	Placebo	Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
BG002	Total	Total of all reporting groups

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

months

Title

Denominators

Categories

Title	Measurements
	OG0006 OG0016

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		Fisher Exact		1.0		Risk Difference (RD)	0.004										No	Superiority or Other

Arm/Groups

ID	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Screening	2	129	52	129
EG001	Pantoprazole Sodium Granules (Open-Label Phase)	4	128	85	128
EG002	Pantoprazole Sodium Granules (Double-blind Phase)	0	54	28	54
EG003	Placebo (Double-blind Phase)	1	54	28	54
EG004	Follow-up	3	127	25	127

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Gastroesophageal reflux disease	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG0030 affected54 at risk EG0040 affected127 at risk
Laryngitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Gastroenteritis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Bronchiolitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Syncope	Vascular disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Otitis media	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Accidental injury	General disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0021 affected54 at risk EG0032 affected54 at risk EG0041 affected127 at risk
Fever	General disorders	Non-systematic Assessment	EG00010 affected129 at risk EG00115 affected128 at risk EG0023 affected54 at risk EG003
Flu syndrome	General disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected54 at risk EG003
Infection	General disorders	Non-systematic Assessment	EG0003 affected129 at risk EG0014 affected128 at risk EG0020 affected54 at risk EG003
Lab test abnormal	General disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Moniliasis	General disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Anorexia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0013 affected128 at risk EG0021 affected54 at risk EG003
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0015 affected128 at risk EG0021 affected54 at risk EG003
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG0005 affected129 at risk EG00114 affected128 at risk EG0022 affected54 at risk EG003
Oral moniliasis	Gastrointestinal disorders	Non-systematic Assessment	EG0002 affected129 at risk EG0017 affected128 at risk EG0021 affected54 at risk EG003
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0017 affected128 at risk EG0023 affected54 at risk EG003
Creatine phosphokinase increased	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0023 affected54 at risk EG003
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected54 at risk EG003
Hyperlipidemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0021 affected54 at risk EG003
Muscle cramp	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected54 at risk EG003
Anxiety	Nervous system disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Emotional lability	Nervous system disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0021 affected54 at risk EG003
Sleep disorder	Nervous system disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0021 affected54 at risk EG003
Twitching	Nervous system disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0021 affected54 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Bronchiolitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected129 at risk EG0013 affected128 at risk EG0022 affected54 at risk EG003
Cough increased	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 affected129 at risk EG0018 affected128 at risk EG0022 affected54 at risk EG003
Laryngitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0022 affected54 at risk EG003
Pharyngitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected128 at risk EG0012 affected128 at risk EG0021 affected54 at risk EG003
Rhinitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0003 affected129 at risk EG00112 affected128 at risk EG0023 affected54 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Upper respiratory infection	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00014 affected129 at risk EG00129 affected128 at risk EG0029 affected54 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Contact dermatitis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0005 affected129 at risk EG0018 affected128 at risk EG0022 affected54 at risk EG003
Cutaneous moniliasis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0015 affected128 at risk EG0021 affected54 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 affected129 at risk EG0015 affected128 at risk EG0020 affected54 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected54 at risk EG003
Furunculosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Impetigo	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Miliaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0003 affected129 at risk EG0014 affected128 at risk EG0023 affected54 at risk EG003
Seborrhea	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0021 affected54 at risk EG003
Conjunctivitis	Eye disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected54 at risk EG003
Otitis media	Ear and labyrinth disorders	Non-systematic Assessment	EG0002 affected129 at risk EG00113 affected128 at risk EG0023 affected54 at risk EG003
Urinary tract infection	Renal and urinary disorders	Non-systematic Assessment	EG0004 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Tooth disorder	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0015 affected128 at risk EG0020 affected54 at risk EG003
Gastroesophageal reflux disease	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0014 affected128 at risk EG0020 affected54 at risk EG003
Hematemesis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Sinusitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0013 affected128 at risk EG0020 affected54 at risk EG003
Stridor	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Abdominal pain	General disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Hernia	General disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Injection site reaction	General disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Flatulence	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Gastroenteritis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0012 affected128 at risk EG0020 affected54 at risk EG003
Alkaline phosphatase increased	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
SGOT increased	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
SGPT increased	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Agitation	Nervous system disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Nervousness	Nervous system disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Nasal septum disorder	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Fungal dermatitis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0015 affected128 at risk EG0020 affected54 at risk EG003
Maculopapular rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Testis disorder	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0011 affected128 at risk EG0020 affected54 at risk EG003
Syncope	Vascular disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Dyspepsia	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Ear pain	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003
Vulvovaginal disorder	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected129 at risk EG0010 affected128 at risk EG0020 affected54 at risk EG003

ID	Term
D005764	Gastroesophageal Reflux

ID	Term
D000077402	Pantoprazole

Ancestor Terms

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

EG0040 affected127 at risk

EG0041 affected127 at risk

EG0040 affected127 at risk

EG0041 affected127 at risk

EG0040 affected127 at risk

EG0041 affected127 at risk

EG0040 affected127 at risk

EG0043 affected127 at risk

EG0040 affected127 at risk

EG0042 affected127 at risk

EG0041 affected127 at risk

EG0040 affected127 at risk

EG0042 affected127 at risk

EG0041 affected127 at risk

EG0040 affected127 at risk

EG0046 affected127 at risk

EG0040 affected127 at risk

EG0041 affected127 at risk

EG0040 affected127 at risk

EG0041 affected127 at risk

EG0044 affected127 at risk

EG0042 affected127 at risk

EG0040 affected127 at risk

EG0041 affected127 at risk

EG0040 affected127 at risk

EG0041 affected127 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama	36604	United States

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases