Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders - Study Results

Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders (PANDA)

This study has been completed.

Study NCT00830115 Information provided by Nycomed

First Received on January 13, 2009. Last Updated on August 20, 2010 History of Changes

Results First Received: July 20, 2010

Study Type:	Observational
Study Design:	Observational Model: Case-Only; Time Perspective: Prospective
Conditions:	Sleep Disorders Non-Erosive Reflux Disease Gastroesophageal Reflux Disease
Intervention:	Drug: Pantoprazole

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients were evaluated, missing values were not imputed.

Reporting Groups

	Description
Pantoprazole	All patients enrolled

Participant Flow: Overall Study

	Pantoprazole
STARTED	1045
COMPLETED	1042
NOT COMPLETED	3
Adverse Event	2
Improvement/recovery	1

Baseline Characteristics

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Reporting Groups

	Description
Pantoprazole	All patients enrolled

Baseline Measures

	Pantoprazole
Number of Participants [units: participants]	1045
Age ^[1] [units: years] Mean ± Standard Deviation	52.9 ± 15.39
Gender, Customized [units: participants]
Female	480
Male	563
Missing data	2
Alcohol use [units: participants]
Daily	173
Not daily	862
Missing data	10
Diagnosis: reflux disease [units: participants]
NERD (Non-Erosive Reflux Disease)	393
eGERD (Erosive Gastro-Esophageal Reflux Disease)	649
Missing Data	3
Drug abuse [units: participants]
Drug abuse	14
No drug abuse	1016
Missing data	15
Nicotine use [units: participants]
Smoker	342
Non-smoker	685
Missing data	18

[1]	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.

Outcome Measures

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1. Primary:

Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) [ Time Frame: 7 days ]

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2. Primary:

Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) [ Time Frame: 7 days ]

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3. Primary:

Physician's Assessment of Sleep Disturbances [ Time Frame: 7 days ]

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4. Secondary:

Patient's Assessment of General Well-being for the Last 24 Hours (Diaries) [ Time Frame: 7 days ]

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5. Secondary:

Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) [ Time Frame: 7 days ]

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6. Secondary:

Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries) [ Time Frame: 7 days ]

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7. Secondary:

Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries) [ Time Frame: 7 days ]

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8. Secondary:

Patient's Assessment of Nausea for the Last 24 Hours (Diaries) [ Time Frame: 7 days ]

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9. Secondary:

Physician's Assessment of Heartburn [ Time Frame: 7 days ]

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10. Secondary:

Physician's Assessment of Acid Eructation [ Time Frame: 7 days ]

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11. Secondary:

Physician's Assessment of Painful Swallowing [ Time Frame: 7 days ]

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12. Secondary:

Assessment of the Efficacy of Pantoprazole at Final Visit [ Time Frame: 7 days ]

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13. Secondary:

Assessment of the Tolerability of Pantoprazole at Final Visit [ Time Frame: 7 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Medical Responsible
Organization: Nycomed Deutschland GmbH
phone: +49 7531 3666 0
e-mail: clinicaltrials@nycomed.com

No publications provided

Responsible Party:	Medical Director, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier:	NCT00830115 History of Changes
Other Study ID Numbers:	P2-9999-010-DE
Study First Received:	January 13, 2009
Results First Received:	July 20, 2010
Last Updated:	August 20, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices