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 |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| 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. |
|---|
Outcome Measures
| 1. Primary: | Assessment of the Severity of Sleep Disturbances [ Time Frame: first and last visit (after a median of 18 days) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Assessment of the Severity of Sleep Disturbances |
| Measure Description | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Time Frame | first and last visit (after a median of 18 days) |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| All patients included and treated, intention to treat, missing values not imputed |
Reporting Groups
| Description | |
|---|---|
| Pantoprazole / Start of Therapy | All patients with valid values ('as observed') |
| Pantoprazole / End of Therapy | All patients with valid values ('as observed') |
Measured Values
| Pantoprazole / Start of Therapy | Pantoprazole / End of Therapy | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
8616 | 8616 |
|
Assessment of the Severity of Sleep Disturbances
[units: percentage of participants] |
||
| None | 13.8 | 77.4 |
| Mild | 38.2 | 20.0 |
| Moderate | 35.9 | 1.1 |
| Severe | 8.0 | 0.07 |
| Missing data | 4.1 | 1.4 |
No statistical analysis provided for Assessment of the Severity of Sleep Disturbances
| 2. Primary: | Assessment of Change of Quality of Sleep During Therapy With Pantoprazole [ Time Frame: last visit (after a median of 18 days) ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Assessment of Change of Quality of Sleep During Therapy With Pantoprazole |
| Measure Description |
Physician's assessment on a scale with
|
| Time Frame | last visit (after a median of 18 days) |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| All patients included and treated, intention to treat, missing values not imputed |
Reporting Groups
| Description | |
|---|---|
| Pantoprazole | All patients with valid values ('as observed') |
Measured Values
| Pantoprazole | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
8616 |
|
Assessment of Change of Quality of Sleep During Therapy With Pantoprazole
[units: percentage of participants] |
|
| Considerably improved | 56.2 |
| Improved | 25.7 |
| Unchanged | 13.5 |
| Missing data | 4.6 |
No statistical analysis provided for Assessment of Change of Quality of Sleep During Therapy With Pantoprazole
| 3. Secondary: | Assessment of the Severity of Heartburn [ Time Frame: first and last visit (after a median of 18 days) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Assessment of the Severity of Heartburn |
| Measure Description | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Time Frame | first and last visit (after a median of 18 days) |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat |
Reporting Groups
| Description | |
|---|---|
| Pantoprazole | All patients with valid values at first and last visit |
Measured Values
| Pantoprazole | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
8540 |
|
Assessment of the Severity of Heartburn
[units: units on a scale] Mean ± Standard Deviation |
|
| Start of therapy | 3.04 ± 0.79 |
| End of study | 1.34 ± 0.51 |
No statistical analysis provided for Assessment of the Severity of Heartburn
| 4. Secondary: | Assessment of the Severity of Eructation/Acid Eructation [ Time Frame: first and last visit (after a median of 18 days) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Assessment of the Severity of Eructation/Acid Eructation |
| Measure Description | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Time Frame | first and last visit (after a median of 18 days) |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat |
Reporting Groups
| Description | |
|---|---|
| Pantoprazole | All patients with valid values at first and last visit |
Measured Values
| Pantoprazole | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
8540 |
|
Assessment of the Severity of Eructation/Acid Eructation
[units: units on a scale] Mean ± Standard Deviation |
|
| Start of therapy | 2.66 ± 0.88 |
| End of study | 1.29 ± 0.49 |
No statistical analysis provided for Assessment of the Severity of Eructation/Acid Eructation
| 5. Secondary: | Assessment of the Severity of Epigastric Complaints/Epigastric Pain [ Time Frame: first and last visit (after a median of 18 days) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Assessment of the Severity of Epigastric Complaints/Epigastric Pain |
| Measure Description | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Time Frame | first and last visit (after a median of 18 days) |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat |
Reporting Groups
| Description | |
|---|---|
| Pantoprazole | All patients with valid values at first and last visit |
Measured Values
| Pantoprazole | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
8528 |
|
Assessment of the Severity of Epigastric Complaints/Epigastric Pain
[units: units on a scale] Mean ± Standard Deviation |
|
| Start of therapy | 2.25 ± 0.91 |
| End of study | 1.18 ± 0.42 |
No statistical analysis provided for Assessment of the Severity of Epigastric Complaints/Epigastric Pain
| 6. Secondary: | Assessment of the Severity of Sensation of Fullness/Abdominal Distension [ Time Frame: first and last visit (after a median of 18 days) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Assessment of the Severity of Sensation of Fullness/Abdominal Distension |
| Measure Description | Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe |
| Time Frame | first and last visit (after a median of 18 days) |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat |
Reporting Groups
| Description | |
|---|---|
| Pantoprazole | All patients with valid values at first and last visit |
Measured Values
| Pantoprazole | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
8516 |
|
Assessment of the Severity of Sensation of Fullness/Abdominal Distension
[units: units on a scale] Mean ± Standard Deviation |
|
| Start of therapy | 2.35 ± 0.95 |
| End of study | 1.28 ± 0.50 |
No statistical analysis provided for Assessment of the Severity of Sensation of Fullness/Abdominal Distension
| 7. Secondary: | Assessment of the Efficacy of Pantoprazole at Final Visit [ Time Frame: last visit (after a median of 18 days) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Assessment of the Efficacy of Pantoprazole at Final Visit |
| Measure Description | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory |
| Time Frame | last visit (after a median of 18 days) |
| Safety Issue | No |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat |
Reporting Groups
| Description | |
|---|---|
| Pantoprazole | Patients included and treated with at least one application of pantoprazole |
Measured Values
| Pantoprazole | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
8616 |
|
Assessment of the Efficacy of Pantoprazole at Final Visit
[units: percentage of participants] |
|
| Excellent | 78.1 |
| Good | 19.6 |
| Satisfactory | 1.3 |
| Not satisfactory | 0.2 |
| Missing data | 0.8 |
No statistical analysis provided for Assessment of the Efficacy of Pantoprazole at Final Visit
| 8. Secondary: | Assessment of the Tolerability of Pantoprazole at Final Visit [ Time Frame: last visit (after a median of 18 days) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Assessment of the Tolerability of Pantoprazole at Final Visit |
| Measure Description | Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory |
| Time Frame | last visit (after a median of 18 days) |
| Safety Issue | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat |
Reporting Groups
| Description | |
|---|---|
| Pantoprazole | Patients included and treated with at least one application of pantoprazole |
Measured Values
| Pantoprazole | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
8616 |
|
Assessment of the Tolerability of Pantoprazole at Final Visit
[units: percentage of participants] |
|
| Excellent | 81.6 |
| Good | 14.8 |
| Satisfactory | 0.4 |
| Not satisfactory | 0.06 |
| Missing data | 3.1 |
No statistical analysis provided for Assessment of the Tolerability of Pantoprazole at Final Visit
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 |
|---|
| 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 |