Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00449813
Other study ID # BY1023/NL511
Secondary ID
Status Terminated
Phase Phase 4
First received March 2, 2007
Last updated May 4, 2012
Start date March 2007
Est. completion date November 2008

Study information

Verified date May 2008
Source Takeda
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

The aim of the study is to compare two different endpoint measures: heartburn as assessed by the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by the patient using the ReQuestâ„¢ questionnaire. The assessment is made in GERD-patients treated with a daily dose of 40 mg oral pantoprazole over an 8-week period.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date November 2008
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Written informed consent

- Outpatients of at least 18 years of age

- History of GERD-related symptoms of at least 6 months prior to baseline visit

- Endoscopically-confirmed GERD or non-erosive GERD

Exclusion Criteria:

- Zollinger-Ellison syndrome or other gastric hypersecretory condition

- Acute peptic ulcer and/or ulcer complications

- Pyloric stenosis

- Severe or unstable cardiovascular, pulmonary, and/or endocrine disease

- Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of reliable contraception in women of child-bearing potential

- Intake of any medication for the purpose of eradication of Helicobacter pylori (H. pylori) within the last 28 days prior to study start

- Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs including cyclooxygenase-2 (COX-2) inhibitors for more than 3 consecutive days within the last 28 days prior to study start; with the exception of acetylsalicylic acid not more than 150 mg per day

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Pantoprazole
40 mg Pantoprazole

Locations

Country Name City State
Netherlands Altana Pharma/Nycomed BT Oss
Netherlands Altana Pharma/Nycomed Den Helder
Netherlands Altana Pharma/Nycomed EH Geldrop
Switzerland Altana Pharma/Nycomed Basel
Switzerland Altana Pharma/Nycomed Basel
Switzerland Altana Pharma/Nycomed Biel/Bienne
Switzerland Altana Pharma/Nycomed Bülach
Switzerland Altana Pharma/Nycomed Locarno, TI.
Switzerland Altana Pharma/Nycomed Luzern
Switzerland Altana Pharma/Nycomed Luzern
Switzerland Altana Pharma/Nycomed Reinach BL
Switzerland Altana Pharma/Nycomed Sion
Switzerland Altana Pharma/Nycomed Thun
Switzerland Altana Pharma/Nycomed Winterthur
Switzerland Altana Pharma/Nycomed Zürich

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Countries where clinical trial is conducted

Netherlands,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of misclassification on day 14 based on heartburn as assessed by the investigator compared to symptom assessment by the patient using the ReQuestâ„¢-gastrointestinal (GI) questionnaire 8 weeks No
Secondary Rate of misclassification on day 14 based on acid regurgitation as assessed by the investigator compared to symptom assessment by the patient using the ReQuestâ„¢-GI questionnaire 8 weeks No
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 NCT01200550 - The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) Patients 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 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 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 NCT00507377 - Foreshortened Esophagus and Its Surgical Therapy
Completed NCT00165022 - Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population N/A
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 NCT00214552 - Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma. Phase 3
Completed NCT00618150 - Patient Education in Gastroesophageal Reflux Disease N/A
Completed NCT03299985 - Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease N/A