TLESR-impedance Study in Patients

NCT00743444 | Completed Phase 2 Results

• 1 other identifier: D9120C00020
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Reflux Episodes

Keywords

GERD; transient lower esophageal sphincter relaxations (TLESRs); reflux

Outcome Measures

Primary Outcomes (1)

• Number of Transient Lower Esophageal Sphincter Relaxations (TLESRs) 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.

  0-3 hours post meal, post third dose

Secondary Outcomes (2)

• Total Number Reflux Episodes 0-24 Hours Post First Dose

  0-24 hours

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

  0-12 hours post first dose

Study Arms (2)

1

EXPERIMENTAL

AZD3355

Drug: AZD3355

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD3355 DRUG

65 mg capsules, oral, 3 single doses

Also known as: Lesogaberan

1

Placebo DRUG

capsules, oral, 3 single doses

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Related Publications (1)

• Boeckxstaens GE, Beaumont H, Mertens V, Denison H, Ruth M, Adler J, Silberg DG, Sifrim D. Effects of lesogaberan on reflux and lower esophageal sphincter function in patients with gastroesophageal reflux disease. Gastroenterology. 2010 Aug;139(2):409-17. doi: 10.1053/j.gastro.2010.04.051. Epub 2010 May 5.

  PMID: 20451523 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

lesogaberan

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Eva Ersdal, PhD

  AstraZeneca R&D, Mölndal, Sweden

  STUDY DIRECTOR

• Daniel Sifrim, MD, PhD

  Center for Gastroenterological Research, Belgium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: February 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 22, 2013
• Results First Posted: June 10, 2011

Record last verified: 2013-07