Efficacy of Pantoprazole in Patients Older Than 12 Years... | NCT00561730

Status Module

Oversight Module

Description 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		All patients enrolled	Drug: Pantoprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pantoprazole	Drug	Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).	Pantoprazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)	Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad	7 days
Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)	Assessment on a scale: Severity from 0=None to 10=Extremely strong	7 days
Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)	Assessment on a scale: Severity from 0=None to 10=Extremely strong	7 days
Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)	Assessment on a scale: Severity from 0=None to 10=Extremely strong	7 days
Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)	Assessment on a scale: Severity from 0=None to 10=Extremely strong	7 days
Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)	Assessment on a scale: Severity from 0=None to 10=Extremely strong	7 days

Secondary Outcomes

Measure	Description	Time Frame
Physician's Assessment of Heartburn	Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe	7 days
Physician's Assessment of Acid Eructation	Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

Eligibility Module

Name	Affiliation	Role
Dr. Thomas D. Bethke, MD, MBA	Nycomed Deutschland GmbH, 78467 Konstanz, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nycomed Deutschland GmbH		Aachen		52078	Germany
Nycomed Deutschland GmbH

Results Section

Participant Flow Module

ID	Title	Description
FG000	Pantoprazole	All patients enrolled

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

The measured value is related to the number of 1977 subjects (= valid cases). This number differs from the overall number of baseline participants due to missing data for 18 subjects.

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00054.1± 15.0

Sex/Gender, Customized

Number

Percentage of participants

Title

Denominators

Categories

Female

Title	Measurements
	BG00046.3

Male

Title	Measurements
	BG000

Nicotine use

Number

Percentage of participants

Title

Denominators

Categories

Smoker

Title	Measurements
	BG00032.5

Non-smoker

Title	Measurements
	BG000

Alcohol use

Number

Percentage of participants

Title

Denominators

Categories

Daily

Title	Measurements
	BG00017.3

Not daily

Title	Measurements
	BG000

Drug abuse

Number

Percentage of participants

Title

Denominators

Categories

Drug abuse

Title	Measurements
	BG0001.0

No drug abuse

Title	Measurements
	BG000

Diagnosis: reflux disease

Number

Percentage of participants

Title

Denominators

Categories

Non-Erosive Reflux Disease (NERD)

Title	Measurements
	BG00035.1

Erosive Gastroesophageal Reflux Disease (eGERD)

Title	Measurements
	BG000

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

Patient's Assessment of General Well-being During the Last 24 Hours (Diaries; ReQuest™ in Practice)

Assessment on a scale: Severity from 0=Excellent to 10=Extremely bad

All patients included and treated, intention to treat, missing values not imputed ('as observed').

Number of valid cases:

Day 0 = 1769
Day 1 = 1760
Day 2 = 1761
Day 3 = 1751
Day 4 = 1749
Day 5 = 1742
Day 6 = 1747

Posted

Mean

Standard Deviation

Units on a scale

7 days

ID	Title	Description
OG000	Pantoprazole	All patients with valid value at least at day 0

Units	Counts
Participants	OG0001769

Title

Denominators

Categories

Day 0

Title	Measurements
	OG0005.31± 2.27

Day 1

Title	Measurements
	OG0004.60± 2.26

Day 2

Primary

Patient's Assessment of Acid Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)

Assessment on a scale: Severity from 0=None to 10=Extremely strong

All patients included and treated, intention to treat, missing values not imputed ('as observed').

Number of valid cases:

Day 0 = 1767
Day 1 = 1758
Day 2 = 1757
Day 3 = 1744
Day 4 = 1743
Day 5 = 1739
Day 6 = 1739

Posted

Mean

Standard Deviation

Units on a scale

7 days

ID	Title	Description
OG000	Pantoprazole	All patients with valid value at least at day 0

Units	Counts
Participants	OG000

Primary

Patient's Assessment of Upper Abdominal/Stomach Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)

Assessment on a scale: Severity from 0=None to 10=Extremely strong

All patients included and treated, intention to treat, missing values not imputed ('as observed').

Number of valid cases:

Day 0 = 1760
Day 1 = 1750
Day 2 = 1746
Day 3 = 1735
Day 4 = 1735
Day 5 = 1730
Day 6 = 1734

Posted

Mean

Standard Deviation

Units on a scale

7 days

ID	Title	Description
OG000	Pantoprazole	All patients with valid value at least at day 0

Units	Counts
Participants	OG000

Primary

Patient's Assessment of Lower Abdominal/Digestive Complaints During the Last 24 Hours (Diaries; ReQuest™ in Practice)

Assessment on a scale: Severity from 0=None to 10=Extremely strong

All patients included and treated, intention to treat, missing values not imputed ('as observed').

Number of valid cases:

Day 0 = 1754
Day 1 = 1742
Day 2 = 1739
Day 3 = 1733
Day 4 = 1730
Day 5 = 1726
Day 6 = 1729

Posted

Mean

Standard Deviation

Units on a scale

7 days

ID	Title	Description
OG000	Pantoprazole	All patients with valid value at least at day 0

Units	Counts
Participants	OG000

Primary

Patient's Assessment of Nausea During the Last 24 Hours (Diaries; ReQuest™ in Practice)

Assessment on a scale: Severity from 0=None to 10=Extremely strong

All patients included and treated, intention to treat, missing values not imputed ('as observed').

Number of valid cases:

Day 0 = 1755
Day 1 = 1744
Day 2 = 1742
Day 3 = 1728
Day 4 = 1727
Day 5 = 1724
Day 6 = 1726

Posted

Mean

Standard Deviation

Units on a scale

7 days

ID	Title	Description
OG000	Pantoprazole	All patients with valid value at least at day 0

Units	Counts
Participants	OG000

Primary

Patient's Assessment of Sleep Disturbances During the Last 24 Hours (Diaries; ReQuest™ in Practice)

Assessment on a scale: Severity from 0=None to 10=Extremely strong

All patients included and treated, intention to treat, missing values not imputed ('as observed').

Number of valid cases:

Day 0 = 1755
Day 1 = 1740
Day 2 = 1740
Day 3 = 1733
Day 4 = 1732
Day 5 = 1725
Day 6 = 1727

Posted

Mean

Standard Deviation

Units on a scale

7 days

ID	Title	Description
OG000	Pantoprazole	All patients with valid value at least at day 0

Units	Counts
Participants	OG000

Secondary

Physician's Assessment of Heartburn

Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Mean

Standard Deviation

Units on a scale

7 days

ID	Title	Description
OG000	Pantoprazole	All patients with valid values at first and last visit

Units	Counts
Participants	OG0001960

Secondary

Physician's Assessment of Acid Eructation

Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Mean

Standard Deviation

Units on a scale

7 days

ID	Title	Description
OG000	Pantoprazole	All patients with valid values at first and last visit

Units	Counts
Participants	OG0001950

Secondary

Physician's Assessment of Painful Swallowing

Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Mean

Standard Deviation

Units on a scale

7 days

ID	Title	Description
OG000	Pantoprazole	All patients with valid values at first and last visit

Units	Counts
Participants	OG0001945

Secondary

Assessment of the Efficacy of Pantoprazole 20 mg/40 mg at Final Visit

Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat

Posted

Number

Percentage of participants

7 days

ID	Title	Description
OG000	Pantoprazole	Patients included and treated with at least one application of pantoprazole

Units	Counts
Participants	OG0001995

Secondary

Assessment of the Tolerability of Pantoprazole 20 mg/40 mg at Final Visit

Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory

Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat

Posted

Number

Percentage of participants

7 days

ID	Title	Description
OG000	Pantoprazole	Patients included and treated with at least one application of pantoprazole

Units	Counts
Participants	OG0001995

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,995 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0004 events4 affected1,995 at risk
Flatulence	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,995 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,995 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,995 at risk
Depressed mood	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,995 at risk
Restlessness	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,995 at risk
Sleep disorder	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment	EG0002 events2 affected1,995 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,995 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,995 at risk

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

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

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nervousness	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected1,995 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected1,995 at risk

ID	Term
D005764	Gastroesophageal Reflux
D000096663	Non-Erosive Reflux Disease