Pantoprazole 20/40 mg in the Treatment of Symptomatic Ref... | NCT00830115

Status Module

Sponsor/Collaborators 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 Stanford Sleepiness Scale for the Last 24 Hours (Diaries)	Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts	7 days
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)	Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired	7 days
Physician's Assessment of Sleep Disturbances	Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe	7 days

Secondary Outcomes

Measure	Description	Time Frame
Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)	Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad	7 days
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Thomas 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

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse 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 1041 subjects (= valid cases). This number differs from the overall number of baseline participants due to missing data for 4 subjects.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00052.9± 15.39

Sex/Gender, Customized

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG000480

Male

Title	Measurements
	BG000

Alcohol use

Number

participants

Title

Denominators

Categories

Daily

Title	Measurements
	BG000173

Not daily

Title	Measurements
	BG000

Diagnosis: reflux disease

Number

participants

Title

Denominators

Categories

NERD (Non-Erosive Reflux Disease)

Title	Measurements
	BG000393

eGERD (Erosive Gastro-Esophageal Reflux Disease)

Title	Measurements
	BG000

Drug abuse

Number

participants

Title

Denominators

Categories

Drug abuse

Title	Measurements
	BG00014

No drug abuse

Title	Measurements
	BG000

Nicotine use

Number

participants

Title

Denominators

Categories

Smoker

Title	Measurements
	BG000342

Non-smoker

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 Stanford Sleepiness Scale for the Last 24 Hours (Diaries)

Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts

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

Number of valid cases:

Day 0 = 869
Day 1 = 868
Day 2 = 867
Day 3 = 864
Day 4 = 863
Day 5 = 859
Day 6 = 862

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	OG000869

Title

Denominators

Categories

Day 0

Title	Measurements
	OG0002.94± 1.58

Day 1

Title	Measurements
	OG0002.62± 1.41

Day 2

Primary

Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)

Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

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

Number of valid cases:

Day 0 = 846
Day 1 = 841
Day 2 = 828
Day 3 = 817
Day 4 = 800
Day 5 = 791
Day 6 = 790

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	OG000846

Primary

Physician's Assessment of Sleep Disturbances

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	OG0001011

Secondary

Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)

Assessment on a scale: Severity from 1=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 = 908
Day 1 = 906
Day 2 = 890
Day 3 = 876
Day 4 = 861
Day 5 = 842
Day 6 = 834

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	OG000908

Secondary

Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)

Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

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

Number of valid cases:

Day 0 = 903
Day 1 = 891
Day 2 = 877
Day 3 = 843
Day 4 = 823
Day 5 = 791
Day 6 = 781

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

Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)

Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

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

Number of valid cases:

Day 0 = 887
Day 1 = 867
Day 2 = 846
Day 3 = 823
Day 4 = 801
Day 5 = 784
Day 6 = 773

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

Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)

Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

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

Number of valid cases:

Day 0 = 798
Day 1 = 782
Day 2 = 769
Day 3 = 759
Day 4 = 752
Day 5 = 739
Day 6 = 738

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

Patient's Assessment of Nausea for the Last 24 Hours (Diaries)

Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired

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

Number of valid cases:

Day 0 = 809
Day 1 = 798
Day 2 = 776
Day 3 = 761
Day 4 = 743
Day 5 = 738
Day 6 = 732

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	OG000809

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	OG0001022

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	OG0001019

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	OG0001017

Secondary

Assessment of the Efficacy of Pantoprazole 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

Participants

7 days

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

Units	Counts
Participants	OG0001045

Secondary

Assessment of the Tolerability of Pantoprazole 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

Participants

7 days

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

Units	Counts
Participants	OG0001045

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pantoprazole	Patients included and treated with at least one application of pantoprazole			0	1,045	4	1,045

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain lower	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,045 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,045 at risk
Flatulence	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,045 at risk
Hypersensitivity	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,045 at risk
Disturbance in attention	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,045 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,045 at risk
Exfoliative rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,045 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,045 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected1,045 at risk

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

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

ID	Term
D012893	Sleep Wake Disorders
D000096663	Non-Erosive Reflux Disease
D005764	Gastroesophageal Reflux