Trial · NCT00444275
Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients
NCT00444275, Phase 4, Completed, AstraZeneca; results first posted 2012-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients. Trials, record NCT00444275. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00444275
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients
- NCT number
- NCT00444275
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 3,029 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- GERD
- Interventions
- esomeprazole (Nexium®), Xolaam®
- First posted
- 2007-03-07
- Last updated
- 2012-12-11
- Other registries' IDs
- eudract:2006-002867-19
- Results first posted
- 2012-12-11
- Limitations and caveats
Planned number of patients not reached: statistical analysis plan revised,comparisons between treatment arms performed globally (No stratified analysis).~Safety pop=3032-3 incorrect enrolments (withdrawals at V2) with no information on ttmt received
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Three Strategies of Long-term Treatment | 16 weeks | Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment? |
| Secondary | Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ). | 4 weeks | Total percentage of subjects for whom evaluation of symptom severity using the Reflux Disease Questionnaire (RDQ) is different, either positively or negatively, as compared to clinical judgment made by Investigator. The RDQ Includes 12 Items: 6 Concern the Frequency of Symptoms Ranging From "Never" for the Lowest Frequency to "Every Day" for the Highest, 6 Others Assess the Severity of Symptoms From "Not at All" to "Strong". The Total Score of the RDQ, Ranging From 0 to 40, is Obtained by Adding the Scores of Each Item. |
| Secondary | Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase | 4 weeks | No possibility to describe as only 2 patients took ASA |
| Secondary | Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase) | 4 to 16 weeks | Change in values of upper digestive symptoms (GORD Impact Scale) from week 4 to week 16. Scale of 1 to 4 : 1 = every day, 2 = often, 3 = sometime, 4 = never) |
| Secondary | Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment | 16 weeks | Failure of treatment (as defined as in primary outcome measure) according to confirmed anxiety and depression during maintenance treatment evaluated by the patient via the score of HADS questionnaire. HADS scale ranges= 0 to 21 (the higher score, the worse : ≤7 : no anxiety-depression/ \[8-10\] : possible anxiety-depression/ \>10 : anxiety-depression) |
| Secondary | Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study | 12 weeks - maintenance treatment phase | Number of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP. |
| Secondary | Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire | Day 0 | May be used to evaluate the severity of symptoms during the initial visit. Not done |
| Secondary | Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire | Day 0 | May be used to offer patients a strategy of treatment during the initial phase and in the long term. Not done |
| Secondary | Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) | Week 4 | May be used to define the success of treatment. Not done |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of Three Strategies of Long-term Treatment | 16 weeks | Percentage of participants with failure | NUMBER | |
| SECONDARY | Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ). | 4 weeks | Percentage of participants | NUMBER | |
| SECONDARY | Impact of Treatment With Low Dose Aspirin (Acetyl Salicylic Acid) Used Concomitantly During the Initial Phase and the Maintenance Phase | 4 weeks | Outcome measure not possible to describe as only 2 patients took Aspirin. | ||
| SECONDARY | Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase) | 4 to 16 weeks | 871 (-66 missing data, 801 (-56 missing data), 833 (-75 missing data) | Scores on scale | MEAN |
| SECONDARY | Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment | 16 weeks | Percent of participants with failure | NUMBER | |
| SECONDARY | Number of Participants and Type of Serious Adverse Events and Adverse Events Leading to a Premature Discontinuation of the Study | 12 weeks - maintenance treatment phase | Participants | NUMBER | |
| SECONDARY | Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire | Day 0 | The results of exploratory analyses are not available. | ||
| SECONDARY | Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) Questionnaire | Day 0 | The results of exploratory analyses are not available. | ||
| SECONDARY | Score Abacuses Based on the Reflux Disease Questionnaire (RDQ) | Week 4 | The results of exploratory analyses are not available. |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Three Strategies of Long-term Treatment | Esomeprazole 20 mg Once Daily (Maintenance Phase) | 10.6 | Percentage of participants with failure | ||
| Efficacy of Three Strategies of Long-term Treatment | Esomeprazole 20 mg on Demand (Maintenance Phase) | 7.8 | Percentage of participants with failure | ||
| Efficacy of Three Strategies of Long-term Treatment | Antacid Treatment (Maintenance Phase) | 43 | Percentage of participants with failure | ||
| Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ). | Esomeprazole 20 mg Once Daily (Initial Phase) | 3.7 | Percentage of participants | ||
| Difference in Symptom Severity Evaluation Performed by the Investigators, When Symptom Severity is Assessed With and Without Reflux Disease Questionnaire (RDQ). | Esomeprazole 40 mg Once Daily (Initial Phase) | 2.3 | Percentage of participants | ||
Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase) | Esomeprazole 20 mg Once Daily (Maintenance Phase) | 0.12 | Standard Deviation 0.79 | Scores on scale | |
Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase) | Esomeprazole 20 mg on Demand (Maintenance Phase) | 0.04 | Standard Deviation 0.73 | Scores on scale | |
Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in Values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase) | Antacid Treatment (Maintenance Phase) | -0.22 | Standard Deviation 0.8 | Scores on scale | |
| Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment | Esomeprazole 20 mg Once Daily (Maintenance Phase) | 9.8 | Percent of participants with failure | ||
| Impact of Anxiety and Depression During the Initial Visit Measured by the HADS ( Hospital Anxiety and Depression Scale) Questionnaire on Response to Initial Treatment and to Maintenance Treatment | Esomeprazole 20 mg on Demand (Maintenance Phase) | 9.3 | Percent of participants with failure |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment Phase | STARTED | Esomeprazole 20 mg Once Daily (Initial Phase) | 2,156 | |
| Initial Treatment Phase | STARTED | Esomeprazole 40 mg Once Daily (Initial Phase) | 873 | |
| Initial Treatment Phase | STARTED | Esomeprazole 20 mg Once Daily (Maintenance Phase) | 0 | |
| Initial Treatment Phase | STARTED | Esomeprazole 20 mg on Demand (Maintenance Phase) | 0 | |
| Initial Treatment Phase | STARTED | Antacid Treatment (Maintenance Phase) | 0 | |
| Initial Treatment Phase | COMPLETED | Esomeprazole 20 mg Once Daily (Initial Phase) | 1,908 | |
| Initial Treatment Phase | COMPLETED | Esomeprazole 40 mg Once Daily (Initial Phase) | 777 | |
| Initial Treatment Phase | COMPLETED | Esomeprazole 20 mg Once Daily (Maintenance Phase) | 0 | |
| Initial Treatment Phase | COMPLETED | Esomeprazole 20 mg on Demand (Maintenance Phase) | 0 | |
| Initial Treatment Phase | COMPLETED | Antacid Treatment (Maintenance Phase) | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events245
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 | Dyspepsia | Vascular disorders | Esomeprazole 20 mg Once Daily (Initial Phase) | 2 | 2,156 | |
| other | Dyspepsia | Vascular disorders | Esomeprazole 40 mg Once Daily (Initial Phase) | 2 | 873 | |
| other | Dyspepsia | Vascular disorders | Esomeprazole 20 mg Once Daily (Maintenance Phase) | 1 | 886 | |
| other | Dyspepsia | Vascular disorders | Esomeprazole 20 mg on Demand (Maintenance Phase) | 1 | 880 | |
| other | Dyspepsia | Vascular disorders | Antacid Treatment (Maintenance Phase) | 3 | 851 | |
| other | Diarrhea | Gastrointestinal disorders | Esomeprazole 20 mg Once Daily (Initial Phase) | 3 | 2,156 | |
| other | Diarrhea | Gastrointestinal disorders | Esomeprazole 40 mg Once Daily (Initial Phase) | 0 | 873 | |
| other | Diarrhea | Gastrointestinal disorders | Esomeprazole 20 mg Once Daily (Maintenance Phase) | 0 | 886 | |
| other | Diarrhea | Gastrointestinal disorders | Esomeprazole 20 mg on Demand (Maintenance Phase) | 0 | 880 | |
| other | Diarrhea | Gastrointestinal disorders | Antacid Treatment (Maintenance Phase) | 1 | 851 |
1 to 10 of 245Source ClinicalTrials.gov
See all 245 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Esomeprazole 20 mg Once Daily (Initial Phase) | ||
| Total, all-cause mortality | Esomeprazole 40 mg Once Daily (Initial Phase) | ||
| Total, all-cause mortality | Esomeprazole 20 mg Once Daily (Maintenance Phase) | ||
| Total, all-cause mortality | Esomeprazole 20 mg on Demand (Maintenance Phase) | ||
| Total, all-cause mortality | Antacid Treatment (Maintenance Phase) | ||
| Total, other adverse events | Esomeprazole 20 mg Once Daily (Initial Phase) | 32 | 2,156 |
| Total, other adverse events | Esomeprazole 40 mg Once Daily (Initial Phase) | 16 | 873 |
| Total, other adverse events | Esomeprazole 20 mg Once Daily (Maintenance Phase) | 5 | 886 |
| Total, other adverse events | Esomeprazole 20 mg on Demand (Maintenance Phase) | 2 | 880 |
| Total, other adverse events | Antacid Treatment (Maintenance Phase) | 13 | 851 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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/NCT00444275
GET https://conductscience.org/api/trials/v1/NCT00444275/flow?page=2