Trial Outcomes & Findings for Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS) (NCT NCT00562094)
NCT ID: NCT00562094
Last Updated: 2012-05-08
Results Overview
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Recruitment status
COMPLETED
Target enrollment
8616 participants
Primary outcome timeframe
first and last visit (after a median of 18 days)
Results posted on
2012-05-08
Participant Flow
Participant milestones
| Measure |
Pantoprazole
All patients enrolled
|
|---|---|
|
Overall Study
STARTED
|
8616
|
|
Overall Study
COMPLETED
|
8554
|
|
Overall Study
NOT COMPLETED
|
62
|
Reasons for withdrawal
| Measure |
Pantoprazole
All patients enrolled
|
|---|---|
|
Overall Study
Lost to Follow-up
|
62
|
Baseline Characteristics
Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS)
Baseline characteristics by cohort
| Measure |
Pantoprazole
n=8616 Participants
All patients enrolled
|
|---|---|
|
Age Continuous
|
55.7 years
STANDARD_DEVIATION 14.51 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
47.8 percentage of participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
51.7 percentage of participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing data
|
0.5 percentage of participants
n=5 Participants
|
|
Nicotine use
Smoker
|
35.2 percentage of participants
n=5 Participants
|
|
Nicotine use
Non-smoker
|
64.1 percentage of participants
n=5 Participants
|
|
Nicotine use
Missing data
|
0.7 percentage of participants
n=5 Participants
|
|
Alcohol use
Daily
|
22.1 percentage of participants
n=5 Participants
|
|
Alcohol use
Not daily
|
77.2 percentage of participants
n=5 Participants
|
|
Alcohol use
Missing data
|
0.8 percentage of participants
n=5 Participants
|
|
Drug abuse
Drug abuse
|
2.9 percentage of participants
n=5 Participants
|
|
Drug abuse
No drug abuse
|
96.0 percentage of participants
n=5 Participants
|
|
Drug abuse
Missing data
|
1.1 percentage of participants
n=5 Participants
|
|
Indication for prescription of pantoprazole
long-term therapy and/or relapse prophylaxis
|
50.5 percentage of participants
n=5 Participants
|
|
Indication for prescription of pantoprazole
Acute reflux oesophagitis
|
49.1 percentage of participants
n=5 Participants
|
|
Indication for prescription of pantoprazole
Missing data
|
0.4 percentage of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: first and last visit (after a median of 18 days)Population: All patients included and treated, intention to treat, missing values not imputed
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Pantoprazole / Start of Therapy
n=8616 Participants
All patients with valid values ('as observed')
|
Pantoprazole / End of Therapy
n=8616 Participants
All patients with valid values ('as observed')
|
|---|---|---|
|
Assessment of the Severity of Sleep Disturbances
None
|
13.8 percentage of participants
|
77.4 percentage of participants
|
|
Assessment of the Severity of Sleep Disturbances
Mild
|
38.2 percentage of participants
|
20.0 percentage of participants
|
|
Assessment of the Severity of Sleep Disturbances
Moderate
|
35.9 percentage of participants
|
1.1 percentage of participants
|
|
Assessment of the Severity of Sleep Disturbances
Severe
|
8.0 percentage of participants
|
0.07 percentage of participants
|
|
Assessment of the Severity of Sleep Disturbances
Missing data
|
4.1 percentage of participants
|
1.4 percentage of participants
|
PRIMARY outcome
Timeframe: last visit (after a median of 18 days)Population: All patients included and treated, intention to treat, missing values not imputed
Physician's assessment on a scale with * considerably improved * improved * unchanged
Outcome measures
| Measure |
Pantoprazole / Start of Therapy
n=8616 Participants
All patients with valid values ('as observed')
|
Pantoprazole / End of Therapy
All patients with valid values ('as observed')
|
|---|---|---|
|
Assessment of Change of Quality of Sleep During Therapy With Pantoprazole
Considerably improved
|
56.2 percentage of participants
|
—
|
|
Assessment of Change of Quality of Sleep During Therapy With Pantoprazole
Improved
|
25.7 percentage of participants
|
—
|
|
Assessment of Change of Quality of Sleep During Therapy With Pantoprazole
Unchanged
|
13.5 percentage of participants
|
—
|
|
Assessment of Change of Quality of Sleep During Therapy With Pantoprazole
Missing data
|
4.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: first and last visit (after a median of 18 days)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Pantoprazole / Start of Therapy
n=8540 Participants
All patients with valid values ('as observed')
|
Pantoprazole / End of Therapy
All patients with valid values ('as observed')
|
|---|---|---|
|
Assessment of the Severity of Heartburn
Start of therapy
|
3.04 units on a scale
Standard Deviation 0.79
|
—
|
|
Assessment of the Severity of Heartburn
End of study
|
1.34 units on a scale
Standard Deviation 0.51
|
—
|
SECONDARY outcome
Timeframe: first and last visit (after a median of 18 days)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Pantoprazole / Start of Therapy
n=8540 Participants
All patients with valid values ('as observed')
|
Pantoprazole / End of Therapy
All patients with valid values ('as observed')
|
|---|---|---|
|
Assessment of the Severity of Eructation/Acid Eructation
Start of therapy
|
2.66 units on a scale
Standard Deviation 0.88
|
—
|
|
Assessment of the Severity of Eructation/Acid Eructation
End of study
|
1.29 units on a scale
Standard Deviation 0.49
|
—
|
SECONDARY outcome
Timeframe: first and last visit (after a median of 18 days)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Pantoprazole / Start of Therapy
n=8528 Participants
All patients with valid values ('as observed')
|
Pantoprazole / End of Therapy
All patients with valid values ('as observed')
|
|---|---|---|
|
Assessment of the Severity of Epigastric Complaints/Epigastric Pain
Start of therapy
|
2.25 units on a scale
Standard Deviation 0.91
|
—
|
|
Assessment of the Severity of Epigastric Complaints/Epigastric Pain
End of study
|
1.18 units on a scale
Standard Deviation 0.42
|
—
|
SECONDARY outcome
Timeframe: first and last visit (after a median of 18 days)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe
Outcome measures
| Measure |
Pantoprazole / Start of Therapy
n=8516 Participants
All patients with valid values ('as observed')
|
Pantoprazole / End of Therapy
All patients with valid values ('as observed')
|
|---|---|---|
|
Assessment of the Severity of Sensation of Fullness/Abdominal Distension
Start of therapy
|
2.35 units on a scale
Standard Deviation 0.95
|
—
|
|
Assessment of the Severity of Sensation of Fullness/Abdominal Distension
End of study
|
1.28 units on a scale
Standard Deviation 0.50
|
—
|
SECONDARY outcome
Timeframe: last visit (after a median of 18 days)Population: Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat
Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Outcome measures
| Measure |
Pantoprazole / Start of Therapy
n=8616 Participants
All patients with valid values ('as observed')
|
Pantoprazole / End of Therapy
All patients with valid values ('as observed')
|
|---|---|---|
|
Assessment of the Efficacy of Pantoprazole at Final Visit
Excellent
|
78.1 percentage of participants
|
—
|
|
Assessment of the Efficacy of Pantoprazole at Final Visit
Good
|
19.6 percentage of participants
|
—
|
|
Assessment of the Efficacy of Pantoprazole at Final Visit
Satisfactory
|
1.3 percentage of participants
|
—
|
|
Assessment of the Efficacy of Pantoprazole at Final Visit
Not satisfactory
|
0.2 percentage of participants
|
—
|
|
Assessment of the Efficacy of Pantoprazole at Final Visit
Missing data
|
0.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: last visit (after a median of 18 days)Population: Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat
Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Outcome measures
| Measure |
Pantoprazole / Start of Therapy
n=8616 Participants
All patients with valid values ('as observed')
|
Pantoprazole / End of Therapy
All patients with valid values ('as observed')
|
|---|---|---|
|
Assessment of the Tolerability of Pantoprazole at Final Visit
Not satisfactory
|
0.06 percentage of participants
|
—
|
|
Assessment of the Tolerability of Pantoprazole at Final Visit
Excellent
|
81.6 percentage of participants
|
—
|
|
Assessment of the Tolerability of Pantoprazole at Final Visit
Good
|
14.8 percentage of participants
|
—
|
|
Assessment of the Tolerability of Pantoprazole at Final Visit
Satisfactory
|
0.4 percentage of participants
|
—
|
|
Assessment of the Tolerability of Pantoprazole at Final Visit
Missing data
|
3.1 percentage of participants
|
—
|
Adverse Events
Pantoprazole
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pantoprazole
n=8616 participants at risk
Patients included and treated with at least one application of pantoprazole
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Renal and urinary disorders
Renal failure acute
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
Other adverse events
| Measure |
Pantoprazole
n=8616 participants at risk
Patients included and treated with at least one application of pantoprazole
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Gastrointestinal disorders
Constipation
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Gastrointestinal disorders
Dyspepsia
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Gastrointestinal disorders
Eructation
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Gastrointestinal disorders
Flatulence
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Immune system disorders
Hypersensitivity
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Metabolism and nutrition disorders
Gout
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Nervous system disorders
Dizziness
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.01%
1/8616 • Number of events 1 • From first until last visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place