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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 the study is to estimate what effect 4 different doses of  AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.

A study to estimate effect of 4 different doses of AZD3355 on reflux episodes, which patients with gastroesophageal reflux disease (GERD) may experience

30 mg orally in the morning and 30 mg in the evening for 1 day

90 mg orally in the morning and 90 mg in the evening for 1 day

120 mg orally in the morning and 120 mg in the evening for 1 day

240 mg orally in the morning and 240 mg in the evening for 1 day

Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

Research Site

A double-blind, placebo controlled, randomised, phase IIA pharmacodynamic 4-way cross-over study to estimate the dose response relationship of AZD3355 on the number of reflux episodes assessed by impedance/pH in patients with GERD and a partial response to PPI treatment

Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)

Age Continuous

Gender, Male/Female

Efficacy Analysis Set (EAS). From the safety analysis set with 27 patients, the EAS excludes 2 patients; 1 due to a positive drug of abuse screen and 1 due to poor quality of the impedance/pH tracings during all 4 study periods. Additionally, 3 patients were partly excluded from the EAS due to poor quality of the tracings during 1 study period.

Total Number of Reflux Episodes During 24 Hours

Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH <4 (or a drop of at least 1 pH unit if pH is already <4) lasting more than 5 s.

Number of Acid Reflux Episodes

Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH 4.0–6.5 lasting more than 5 s.

Number of Weakly Acidic Reflux Episodes

Number of reflux episodes as defined for the primary outcome measure with an intraesophageal pH ≥6.5 lasting more than 5 s.

Arms	Assigned Interventions
Experimental: A AZD3355 30 mg	Drug: AZD3355 30 mg orally in the morning and 30 mg in the evening for 1 day
Experimental: B AZD3355 90 mg	Drug: AZD3355 90 mg orally in the morning and 90 mg in the evening for 1 day
Experimental: C AZD3355 120 mg	Drug: AZD3355 120 mg orally in the morning and 120 mg in the evening for 1 day
Experimental: D AZD3355 240 mg	Drug: AZD3355 240 mg orally in the morning and 240 mg in the evening for 1 day
Placebo Comparator: E Placebo	Drug: placebo Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

A study to estimate effect of 4 different doses of AZD3355 on reflux episodes, which patients with gastroesophageal reflux disease (GERD) may experience

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=431&filename=CSR-D9120C00032.pdf

CSR-D9120C00032.pdf

D9120C00032_Protocol

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator