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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.

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Official Title

Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant improvement of heartburn after 8-week treatment.

To assess the efficacy of esomeprazole 20mg once daily in subjects who still had heartburn after receiving rabeprazole

esomeprazole 20 mg once daily for 8 weeks

An 8-week, open label, multicentre study to assess the efficacy of esomeprazole 20 mg once daily in subjects with continuing symptoms of heartburn following treatment with a previous rabeprazole

The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.

Age Continuous

Gender, Male/Female

Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.

Change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1).

The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.

101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.

Change in the frequency of heartburn during the 7-day period prior to the 4 week visit (Visit 2) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1).

Improved

Unchanged

Worsened

Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened".

Change in the maximum severity of heartburn during the 7-day period prior to the 4 week visit (Visit 2) compared to the maximum severity of heartburn during the 7-day period prior to baseline (Visit 1).

Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into "Improved". If the value was same, then categorised into "Unchanged". If the value was worsened, categorised into "Worsened".

Change in the maximum severity of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the maximum severity of heartburn during the 7-day period prior to baseline (Visit 1).

Overall Study

Participants with a history of reflux oesophagitis and with continuing heartburn after previous treatment with rabeprazole 10 mg were included in this study.

To assess the efficacy of esomeprazole 20mg once daily in subjects who still had heartburn after receiving rabeprazole

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=449&filename=CSR-D961HL00002.pdf

CSR-D961HL00002.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator