Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00551473
Other study ID # LAV110285
Secondary ID
Status Completed
Phase Phase 1
First received October 29, 2007
Last updated May 31, 2012
Start date May 2007

Study information

Verified date February 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

Current treatment for gastroesophageal reflux disease(GERD)confirms an unmet need in patients, based on slow onset of action and an inability to provide 24-hour gastric acid suppression. Clinical data on lavoltidine demonstrates a rapid onset of action, high potency, and prolonged duration of effect after single dose. Since tolerance to the class of compounds to which lavoltidine belongs may be dose dependent, the current study is designed to determine if 40mg lavoltdine given for 7days develops tolerance.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Healthy male, from 18-55 years

- Have BMI from 19-30 kg/m2

- do not present with abnormal clinical lab findings

- are able to tolerate a nasogastric pH electrode.

Exclusion Criteria:

- Helicobacter-positive on a C13 urea breath test

- have a baseline median 24-hour gastric pH>3

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Drug:
Lavoltidine


Locations

Country Name City State
Australia GSK Investigational Site Randwick, Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the degree of pharmacodynamic tolerance following seven days administration of lavoltidine 40mg on gastric pH as assessed by percentage of 24hrs pH>4. seven days
Secondary To determine whether or not significant pharmacodynamic tolerance occurs as early as the second dose of 40mg lavoltidine. Safety and tolerance of seven days administration of lavoltidine 40 mg, in healthy male volunteers. seven days
See also
  Status Clinical Trial Phase
Completed NCT02135107 - A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients Phase 3
Completed NCT01432392 - Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease N/A
Recruiting NCT01249482 - Symptom Assessment for GERD Patients Receiving H. Pylori Eradication N/A
Completed NCT01578642 - Feasibility Study for Evaluating the Effect of Electrical Stimulation on Lower Esophageal Sphincter Pressure and Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease Phase 2
Completed NCT01200550 - The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) Patients N/A
Completed NCT00978016 - A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD) Phase 2
Unknown status NCT01128608 - The Effect of High PCO2 Solution on Esophageal Acid Sensation N/A
Completed NCT00998244 - Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease N/A
Completed NCT00768196 - Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients N/A
Completed NCT00768443 - Symptoms and Management Strategies in Gastroesophageal Reflux Disease (GERD) N/A
Recruiting NCT00498082 - Determinants of Efficacy of EsophyX Treatment in Gastro-Esophageal Reflux Disease N/A
Completed NCT00886197 - Diagnostic Efficacy of Narrow Band Imaging in Patients With Gastroesophageal Reflux Disease N/A
Completed NCT00378898 - Feasibility of Placing Bravo PH Capsule in Proximal Esophagus N/A
Completed NCT00507377 - Foreshortened Esophagus and Its Surgical Therapy
Completed NCT00217347 - Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy N/A
Completed NCT00165022 - Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population N/A
Completed NCT00214552 - Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma. Phase 3
Completed NCT00625495 - Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD) Phase 4
Completed NCT00618150 - Patient Education in Gastroesophageal Reflux Disease N/A
Completed NCT03299985 - Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease N/A