Efficacy of Pantoprazole 20/40 mg Once Daily (od) in Pati... | NCT00829738

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
Group 1		All patients enrolled	Drug: Pantoprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pantoprazole	Drug	This was an observational study. Therefore, the physician decided about dosage according to individual needs (20 or 40 mg pantoprazole).	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe	14 days
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe	14 days
Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe	14 days
Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms	Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory	14 days

Secondary Outcomes

Measure	Description	Time Frame
Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe	14 days
Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness

Eligibility Module

Contacts/Locations Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Nycomed Deutschland GmbH		Aachen		52072	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 4125 subjects (= valid cases). This number differs from the overall number of baseline participants due to missing data for 63 subjects.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.3± 14.82

Sex/Gender, Customized

Number

percentage of participants

Title

Denominators

Categories

Female

Title	Measurements
	BG00047.6

Male

Title	Measurements
	BG000

Nicotine use

Number

percentage of participants

Title

Denominators

Categories

Smoker

Title	Measurements
	BG00036.7

Non-smoker

Title	Measurements
	BG000

Alcohol use

Number

percentage of participants

Title

Denominators

Categories

Daily

Title	Measurements
	BG00021.9

Not daily

Title	Measurements
	BG000

Drug abuse

Number

percentage of participants

Title

Denominators

Categories

Drug abuse

Title	Measurements
	BG0003.6

No drug abuse

Title	Measurements
	BG000

Indication for prescription of pantoprazole

Number

percentage of participants

Title

Denominators

Categories

Long-term therapy and/or relapse prophylaxis

Title	Measurements
	BG00039.8

Acute reflux oesophagitis

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

Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Heartburn

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004155

Title

Denominators

Categories

Start of therapy

Title	Measurements
	OG0003.10± 0.80

End of study

Title	Measurements
	OG0001.36± 0.52

Primary

Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Eructation/Sour Eructation

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004155

Primary

Reflux-associated Gastrointestinal Symptoms: Assessment of the Severity of Painful Swallowing

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004127

Primary

Assessment of Pantoprazole at Final Visit: Efficacy Regarding Reflux Symptoms

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004188

Secondary

Functional Dyspepsia Symptoms: Assessment of the Severity of Upper Abdominal Pain

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004129

Secondary

Functional Dyspepsia Symptoms: Assessment of the Severity of Sensation of Fullness

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004122

Secondary

Functional Dyspepsia Symptoms: Assessment of the Severity of Nausea

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004055

Secondary

Assessment of Pantoprazole at Final Visit: Efficacy Regarding Dyspeptic Symptoms

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004188

Secondary

Irritable Bowel Syndrome: Assessment of the Severity of Lower Abdominal Pain

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004099

Secondary

Irritable Bowel Syndrome: Assessment of the Severity of Diarrhoea

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004087

Secondary

Irritable Bowel Syndrome: Assessment of the Severity of Constipation

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004090

Secondary

Assessment of Pantoprazole at Final Visit: Efficacy Regarding Irritable Bowel Syndrome

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004188

Secondary

Assessment of the Tolerability of Pantoprazole at Final Visit

Physician's assessment on a scale with 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

14 days

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

Units	Counts
Participants	OG0004188

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			2	4,188	3	4,188

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected4,188 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected4,188 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected4,188 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected4,188 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected4,188 at risk
Alanine aminotransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected4,188 at risk
Dizziness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected4,188 at risk

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