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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 compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.

TLESR-impedance study in patients

A double-blind, placebo controlled, randomized, two centre phase IIA pharmacodynamic cross-over study to assess the effect of AZD3355, 65 mg bid, on transient lower esophageal sphincter relaxations (TLESRs) in GERD patients with an incomplete response to PPI treatment

The number of relaxations for each patient in each period was determined from manometric tracings according to previously published criteria (R.H. Holloway, R. Penagini and A.C. Ireland, Criteria for objective definition of transient lower esophageal sphincter relaxation, Am J Physiol 268 (1995), pp. G128-G133).

The analysis of the number of TLESRs was based on an analysis of variance (ANOVA) for log-transformed data. The 95% level confidence interval (CI) limits were transformed back to the original scale to give CIs for the geometric mean for each treatment.

Age Continuous

Gender, Male/Female

Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from the primary analysis; 1 due to catheter placement problems, 1 due to error in dose administration, 1 due to low LESP, 1 due to multiple swallowing.

Number of transient lower esophageal sphincter relaxations (TLESRs) 0-3 hours post meal, post third dose

Number of reflux episodes assessed during the 24-hour ambulatory impedance-pH recording.

Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 4 patients were excluded from this analysis; 1 due to catheter placement problems, 1 due to
error in dose administration, 2 due to insufficient impedance/pH recording time.

Total number reflux episodes 0-24 hours post first dose

The AUCtau was calculated for each patient in the period with AZD3355 treatment by the Log-Linear Trapezoidal Method. The descriptive geometric mean of the individual AUCtau values is reported here.

Per Protocol Analysis Set (PP). From the safety analysis set with 27 patients, the PP excludes 2 patients since they discontinued prematurely from the study. Additionally, 1 patient was excluded from the pharmacokinetic analysis due to error in dose administration at dose 2.

Arms	Assigned Interventions
Experimental: 1 AZD3355	Drug: AZD3355 65 mg capsules, oral, 3 single doses Other Name: Lesogaberan
Placebo Comparator: 2	Drug: Placebo capsules, oral, 3 single doses

TLESR-impedance study in 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=429&filename=CSR-D9120C00020.pdf

CSR-D9120C00020.pdf

Trial Results Summaries

Contacts

Investigators

Principal Investigator