TLESR-impedance Study in Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00743444
First received: August 26, 2008
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Reflux Episodes
Drug: AZD3355
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Total Number Reflux Episodes 0-24 Hours Post First Dose [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
    Number of reflux episodes assessed during the 24-hour ambulatory impedance-pH recording.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: February 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743444

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eva Ersdal, PhD AstraZeneca R&D, Mölndal, Sweden
Principal Investigator: Daniel Sifrim, MD, PhD Center for Gastroenterological Research, Belgium
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00743444     History of Changes
Other Study ID Numbers: D9120C00020
Study First Received: August 26, 2008
Results First Received: March 16, 2011
Last Updated: July 17, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by AstraZeneca:
GERD
transient lower esophageal sphincter relaxations (TLESRs)
reflux

Additional relevant MeSH terms:
Lesogaberan
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014