Trial · NCT00830115
Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders
NCT00830115, Completed, Nycomed; results first posted 2010-09-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders. Trials, record NCT00830115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00830115
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders
- NCT number
- NCT00830115
- Status
- Completed
- Enrollment
- 1,045 participants, actual
- Lead sponsor
- Nycomed
- Conditions
- Sleep Disorders, Non-Erosive Reflux Disease, Gastroesophageal Reflux Disease
- Interventions
- Pantoprazole
- First posted
- 2009-01-27
- Last updated
- 2012-05-08
- Results first posted
- 2010-09-15
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts |
| Primary | Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired |
| Primary | Physician's Assessment of Sleep Disturbances | 7 days | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe |
| Secondary | Patient's Assessment of General Well-being for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad |
| Secondary | Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired |
| Secondary | Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired |
| Secondary | Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired |
| Secondary | Patient's Assessment of Nausea for the Last 24 Hours (Diaries) | 7 days | Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired |
| Secondary | Physician's Assessment of Heartburn | 7 days | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe |
| Secondary | Physician's Assessment of Acid Eructation | 7 days | Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) | 7 days | All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~* Day 0 = 869~* Day 1 = 868~* Day 2 = 867~* Day 3 = 864~* Day 4 = 863~* Day 5 = 859~* Day 6 = 862 | Units on a scale | MEAN |
| PRIMARY | Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) | 7 days | All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~* Day 0 = 846~* Day 1 = 841~* Day 2 = 828~* Day 3 = 817~* Day 4 = 800~* Day 5 = 791~* Day 6 = 790 | Units on a scale | MEAN |
| PRIMARY | Physician's Assessment of Sleep Disturbances | 7 days | Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat | Units on a scale | MEAN |
| SECONDARY | Patient's Assessment of General Well-being for the Last 24 Hours (Diaries) | 7 days | All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~* Day 0 = 908~* Day 1 = 906~* Day 2 = 890~* Day 3 = 876~* Day 4 = 861~* Day 5 = 842~* Day 6 = 834 | Units on a scale | MEAN |
| SECONDARY | Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries) | 7 days | All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~* Day 0 = 903~* Day 1 = 891~* Day 2 = 877~* Day 3 = 843~* Day 4 = 823~* Day 5 = 791~* Day 6 = 781 | Units on a scale | MEAN |
| SECONDARY | Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries) | 7 days | All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~* Day 0 = 887~* Day 1 = 867~* Day 2 = 846~* Day 3 = 823~* Day 4 = 801~* Day 5 = 784~* Day 6 = 773 | Units on a scale | MEAN |
| SECONDARY | Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries) | 7 days | All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~* Day 0 = 798~* Day 1 = 782~* Day 2 = 769~* Day 3 = 759~* Day 4 = 752~* Day 5 = 739~* Day 6 = 738 | Units on a scale | MEAN |
| SECONDARY | Patient's Assessment of Nausea for the Last 24 Hours (Diaries) | 7 days | All patients included and treated, intention to treat, missing values not imputed ('as observed').~Number of valid cases:~* Day 0 = 809~* Day 1 = 798~* Day 2 = 776~* Day 3 = 761~* Day 4 = 743~* Day 5 = 738~* Day 6 = 732 | Units on a scale | MEAN |
| SECONDARY | Physician's Assessment of Heartburn | 7 days | Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat | Units on a scale | MEAN |
| SECONDARY | Physician's Assessment of Acid Eructation | 7 days | Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat | Units on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group67
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) | Pantoprazole | Day 0 | 2.94 | Standard Deviation 1.58 | Units on a scale |
| Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) | Pantoprazole | Day 1 | 2.62 | Standard Deviation 1.41 | Units on a scale |
| Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) | Pantoprazole | Day 2 | 2.28 | Standard Deviation 1.23 | Units on a scale |
| Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) | Pantoprazole | Day 3 | 2.03 | Standard Deviation 1.12 | Units on a scale |
| Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) | Pantoprazole | Day 4 | 1.86 | Standard Deviation 1.06 | Units on a scale |
| Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) | Pantoprazole | Day 5 | 1.74 | Standard Deviation 1.02 | Units on a scale |
| Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) | Pantoprazole | Day 6 | 1.67 | Standard Deviation 1.01 | Units on a scale |
| Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) | Pantoprazole | Day 0 | 3.65 | Standard Deviation 2.39 | Units on a scale |
| Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) | Pantoprazole | Day 1 | 3.07 | Standard Deviation 2.11 | Units on a scale |
| Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries) | Pantoprazole | Day 2 | 2.53 | Standard Deviation 1.84 | Units on a scale |
1 to 10 of 67Source ClinicalTrials.gov
See all 67 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pantoprazole | 1,045 | |
| Overall Study | COMPLETED | Pantoprazole | 1,042 | |
| Overall Study | NOT COMPLETED | Pantoprazole | 3 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain lower | Gastrointestinal disorders | Pantoprazole | 1 | 1,045 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Pantoprazole | 1 | 1,045 | 1 |
| other | Flatulence | Gastrointestinal disorders | Pantoprazole | 1 | 1,045 | 1 |
| other | Hypersensitivity | Immune system disorders | Pantoprazole | 1 | 1,045 | 1 |
| other | Disturbance in attention | Nervous system disorders | Pantoprazole | 1 | 1,045 | 1 |
| other | Headache | Nervous system disorders | Pantoprazole | 1 | 1,045 | 1 |
| other | Exfoliative rash | Skin and subcutaneous tissue disorders | Pantoprazole | 1 | 1,045 | 1 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Pantoprazole | 1 | 1,045 | 1 |
| other | Rash macular | Skin and subcutaneous tissue disorders | Pantoprazole | 1 | 1,045 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pantoprazole | ||
| Total, other adverse events | Pantoprazole | 4 | 1,045 |
| Total, serious adverse events | Pantoprazole | 0 | 1,045 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00830115
GET https://conductscience.org/api/trials/v1/NCT00830115/results?page=2