Efficacy of Pantoprazole in Patients Older Than 12 Years... | NCT00562094

Status Module

Sponsor/Collaborators Module

Oversight Module

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			Drug: Pantoprazole

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.	Pantoprazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of the Severity of Sleep Disturbances	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe	first and last visit (after a median of 18 days)
Assessment of Change of Quality of Sleep During Therapy With Pantoprazole	Physician's assessment on a scale with considerably improved improved unchanged	last visit (after a median of 18 days)

Secondary Outcomes

Measure	Description	Time Frame
Assessment of the Severity of Heartburn	Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe	first and last visit (after a median of 18 days)
Assessment of the Severity of Eructation/Acid Eructation

Eligibility Module

Contacts/Locations 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		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 8502 subjects (= valid cases). This number differs from the overall number of baseline participants due to missing data for 114 subjects.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.7± 14.51

Sex/Gender, Customized

Number

percentage of participants

Title

Denominators

Categories

Female

Title	Measurements
	BG00047.8

Male

Title	Measurements
	BG000

Nicotine use

Number

percentage of participants

Title

Denominators

Categories

Smoker

Title	Measurements
	BG00035.2

Non-smoker

Title	Measurements
	BG000

Alcohol use

Number

percentage of participants

Title

Denominators

Categories

Daily

Title	Measurements
	BG00022.1

Not daily

Title	Measurements
	BG000

Drug abuse

Number

percentage of participants

Title

Denominators

Categories

Drug abuse

Title	Measurements
	BG0002.9

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
	BG00050.5

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

Assessment of the Severity of Sleep Disturbances

Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe

All patients included and treated, intention to treat, missing values not imputed

Posted

Number

percentage of participants

first and last visit (after a median of 18 days)

ID	Title	Description
OG000	Pantoprazole / Start of Therapy	All patients with valid values ('as observed')
OG001	Pantoprazole / End of Therapy	All patients with valid values ('as observed')

Units	Counts
Participants	OG0008616 OG0018616

Title

Denominators

Categories

None

Title	Measurements
	OG00013.8 OG00177.4

Mild

Title	Measurements
	OG000

Primary

Assessment of Change of Quality of Sleep During Therapy With Pantoprazole

Physician's assessment on a scale with

considerably improved
improved
unchanged

All patients included and treated, intention to treat, missing values not imputed

Posted

Number

percentage of participants

last visit (after a median of 18 days)

ID	Title	Description
OG000	Pantoprazole	All patients with valid values ('as observed')

Units	Counts
Participants	OG0008616

Secondary

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

first and last visit (after a median of 18 days)

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

Units	Counts
Participants	OG0008540

Secondary

Assessment of the Severity of Eructation/Acid 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

first and last visit (after a median of 18 days)

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

Units	Counts
Participants	OG0008540

Secondary

Assessment of the Severity of Epigastric Complaints/Epigastric 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

first and last visit (after a median of 18 days)

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

Units	Counts
Participants	OG0008528

Secondary

Assessment of the Severity of Sensation of Fullness/Abdominal Distension

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

first and last visit (after a median of 18 days)

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

Units	Counts
Participants	OG0008516

Secondary

Assessment of the Efficacy 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

last visit (after a median of 18 days)

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

Units	Counts
Participants	OG0008616

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

last visit (after a median of 18 days)

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

Units	Counts
Participants	OG0008616

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	8,616	11	8,616

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected8,616 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected8,616 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Eructation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Flatulence	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Hypersensitivity	Immune system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Gout	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Dizziness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment	EG0001 events1 affected8,616 at risk

Ancestor Terms

ID	Term
D005764	Gastroesophageal Reflux
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders

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

Title

Denominators

Categories

Considerably improved

Title	Measurements
	OG00056.2

Improved

Title	Measurements
	OG00025.7

Unchanged

Title	Measurements
	OG00013.5

Missing data

Title	Measurements
	OG0004.6

Title

Denominators

Categories

Excellent

Title	Measurements
	OG00078.1

Good

Title	Measurements
	OG00019.6

Satisfactory

Title	Measurements
	OG0001.3

Not satisfactory

Title	Measurements
	OG0000.2

Missing data

Title	Measurements
	OG0000.8

Title

Denominators

Categories

Excellent

Title	Measurements
	OG00081.6

Good

Title	Measurements
	OG00014.8

Satisfactory

Title	Measurements
	OG0000.4

Not satisfactory

Title	Measurements
	OG0000.06

Missing data

Title	Measurements
	OG0003.1

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