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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

The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment.

Symptom improvements in Gastroesophageal reflux disease (GERD) patients

Research Site

A randomized, double-blind, placebo controlled, phase IIA study to assess the effect on Gastroesophageal reflux disease (GERD) symptoms, Pharmacokinetics, safety and tolerability of 4 weeks treatment with AZD3355 65 mg bid as add-on treatment to a Proton pump inhibitor (PPI) in patients with an incomplete response to PPI.

Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Disease Questionnaire (RDQ) diary

Age Continuous

Gender, Male/Female

Number of participants with at most one day with not more than mild intensity of the symptoms ‘a burning feeling behind the breastbone’ and ‘unpleasant movement of material upwards from the stomach’ during the last seven days of treatment

Plasma concentration (µmol/L) of AZD3355 analysed from blood sample taken in the interval one to two hours after the first intake of AZD3355 65 mg capsule

Symptom improvements in Gastroesophageal reflux disease (GERD) patients

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=427&filename=CSR-D9120C00011.pdf

CSR-D9120C00011.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator