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TLESR-impedance Study in Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00743444
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : June 10, 2011
Last Update Posted : July 22, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Reflux Episodes Drug: AZD3355 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: 1
Drug: AZD3355
65 mg capsules, oral, 3 single doses
Other Name: Lesogaberan

Placebo Comparator: 2 Drug: Placebo
capsules, oral, 3 single doses

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00743444

Sponsors and Collaborators
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Study Director: Eva Ersdal, PhD AstraZeneca R&D, Mölndal, Sweden
Principal Investigator: Daniel Sifrim, MD, PhD Center for Gastroenterological Research, Belgium
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AstraZeneca Identifier: NCT00743444    
Other Study ID Numbers: D9120C00020
First Posted: August 28, 2008    Key Record Dates
Results First Posted: June 10, 2011
Last Update Posted: July 22, 2013
Last Verified: July 2013
Keywords provided by AstraZeneca:
transient lower esophageal sphincter relaxations (TLESRs)
Additional relevant MeSH terms:
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Gastrointestinal Agents
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs