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OpenTrials
Completed

NCT Number: NCT00743444

TLESR-impedance Study in Patients

The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.

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Key information

Conditions

Reflux Episodes Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of written consent
  • GERD patients, age 18-70 years, females must be postmenopausal or surgically sterilised
  • 6 months history of GERD and incomplete response to PPI treatment

Exclusion criteria

  • Insufficient symptom burden of the reflux disease evaluated by questionnaires
  • S-creatinine >1.2 times upper limit of normal
  • History of heart disease
  • Prior surgery of the upper GI tract

Treatment and study plan

AZD3355

Drug

65 mg capsules, oral, 3 single doses

Other names: Lesogaberan

Placebo

Drug

capsules, oral, 3 single doses

Primary outcomes

  1. Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 0-3 Hours Post Meal, Post Third Dose

    Time frame: 0-3 hours post meal, post third dose

    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.

Secondary outcomes

  1. Total Number Reflux Episodes 0-24 Hours Post First Dose

    Time frame: 0-24 hours

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

  2. Area Under the Plasma Concentration vs. Time Curve (AUCtau) During 0-12 Hours Post First Dose Calculated by the Log/Linear Trapezoidal Method.

    Time frame: 0-12 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 28, 2008
Registry last updated
Jul 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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