Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS)
This study has been completed.
Sponsor:
Nycomed: A Takeda Company
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00562094
First received: November 12, 2007
Last updated: May 4, 2012
Last verified: May 2012
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Results First Received: September 1, 2010
| Study Type: | Observational |
|---|---|
| Study Design: | Observational Model: Cohort; Time Perspective: Prospective |
| Conditions: |
Erosive Gastroesophageal Reflux Disease Non-Erosive Reflux Disease |
| Intervention: |
Drug: Pantoprazole |
Participant Flow
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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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Pantoprazole | All patients enrolled |
Participant Flow: Overall Study
| Pantoprazole | |
|---|---|
| STARTED | 8616 |
| COMPLETED | 8554 |
| NOT COMPLETED | 62 |
| Lost to Follow-up | 62 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Pantoprazole | All patients enrolled |
Baseline Measures
| Pantoprazole | |
|---|---|
|
Number of Participants
[units: participants] |
8616 |
|
Age
[1] [units: years] Mean ± Standard Deviation |
55.7 ± 14.51 |
|
Gender, Customized
[units: percentage of participants] |
|
| Female | 47.8 |
| Male | 51.7 |
| Missing data | 0.5 |
|
Nicotine use
[units: percentage of participants] |
|
| Smoker | 35.2 |
| Non-smoker | 64.1 |
| Missing data | 0.7 |
|
Alcohol use
[units: percentage of participants] |
|
| Daily | 22.1 |
| Not daily | 77.2 |
| Missing data | 0.8 |
|
Drug abuse
[units: percentage of participants] |
|
| Drug abuse | 2.9 |
| No drug abuse | 96.0 |
| Missing data | 1.1 |
|
Indication for prescription of pantoprazole
[units: percentage of participants] |
|
| long-term therapy and/or relapse prophylaxis | 50.5 |
| Acute reflux oesophagitis | 49.1 |
| Missing data | 0.4 |
| [1] | 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. |
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Outcome Measures
| 1. Primary: | Assessment of the Severity of Sleep Disturbances [ Time Frame: first and last visit (after a median of 18 days) ] |
| 2. Primary: | Assessment of Change of Quality of Sleep During Therapy With Pantoprazole [ Time Frame: last visit (after a median of 18 days) ] |
| 3. Secondary: | Assessment of the Severity of Heartburn [ Time Frame: first and last visit (after a median of 18 days) ] |
| 4. Secondary: | Assessment of the Severity of Eructation/Acid Eructation [ Time Frame: first and last visit (after a median of 18 days) ] |
| 5. Secondary: | Assessment of the Severity of Epigastric Complaints/Epigastric Pain [ Time Frame: first and last visit (after a median of 18 days) ] |
| 6. Secondary: | Assessment of the Severity of Sensation of Fullness/Abdominal Distension [ Time Frame: first and last visit (after a median of 18 days) ] |
| 7. Secondary: | Assessment of the Efficacy of Pantoprazole at Final Visit [ Time Frame: last visit (after a median of 18 days) ] |
| 8. Secondary: | Assessment of the Tolerability of Pantoprazole at Final Visit [ Time Frame: last visit (after a median of 18 days) ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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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| No text entered. |
Results Point of Contact:
Name/Title: Medical Responsible
Organization: Nycomed Deutschland GmbH
phone: +49 7531 3666 0
e-mail: clinicaltrials@nycomed.com
Organization: Nycomed Deutschland GmbH
phone: +49 7531 3666 0
e-mail: clinicaltrials@nycomed.com
No publications provided
| Responsible Party: | Medical Responsible, Nycomed Deutschland GmbH |
| ClinicalTrials.gov Identifier: | NCT00562094 History of Changes |
| Other Study ID Numbers: | PAN 20/40 PULS 07/10 |
| Study First Received: | November 12, 2007 |
| Results First Received: | September 1, 2010 |
| Last Updated: | May 4, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |