NCT00449813

Brief 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 ReQuest™ questionnaire. The assessment is made in GERD-patients treated with a daily dose of 40 mg oral pantoprazole over an 8-week period.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Geographic Reach
2 countries

15 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

May 7, 2012

Status Verified

May 1, 2008

Enrollment Period

7 months

First QC Date

March 2, 2007

Last Update Submit

May 4, 2012

Conditions

Gastroesophageal Reflux DiseaseNon-erosive Reflux Disease

Keywords

Gastroesophageal reflux disease (GERD)Non erosive reflux disease (NERD)

Outcome Measures

Primary Outcomes (1)

  • Rate of misclassification on day 14 based on heartburn as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-gastrointestinal (GI) questionnaire

    8 weeks

Secondary Outcomes (1)

  • Rate of misclassification on day 14 based on acid regurgitation as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-GI questionnaire

    8 weeks

Study Arms (1)

1.

ACTIVE COMPARATOR

40 mg Pantoprazole

Drug: Pantoprazole

Interventions

PantoprazoleDRUG

40 mg Pantoprazole

1.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Altana Pharma/Nycomed

BT Oss, 5342, Netherlands

Location

Altana Pharma/Nycomed

Den Helder, 1782 GZ, Netherlands

Location

Altana Pharma/Nycomed

EH Geldrop, 5664, Netherlands

Location

Altana Pharma/Nycomed

Basel, 4001, Switzerland

Location

Altana Pharma/Nycomed

Basel, 4051, Switzerland

Location

Altana Pharma/Nycomed

Biel/Bienne, 2502, Switzerland

Location

Altana Pharma/Nycomed

Bülach, 8180, Switzerland

Location

Altana Pharma/Nycomed

Locarno, TI., 6600, Switzerland

Location

Altana Pharma/Nycomed

Lucerne, 6003, Switzerland

Location

Altana Pharma/Nycomed

Lucerne, 6004, Switzerland

Location

Altana Pharma/Nycomed

Reinach, 4153, Switzerland

Location

Altana Pharma/Nycomed

Sion, 1950, Switzerland

Location

Altana Pharma/Nycomed

Thun, 3600, Switzerland

Location

Altana Pharma/Nycomed

Winterthur, 8400, Switzerland

Location

Altana Pharma/Nycomed

Zurich, 8050, Switzerland

Location

MeSH Terms

Conditions

Gastroesophageal RefluxNon-Erosive Reflux Disease

Interventions

Pantoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • M. Oudkerk Pool, Prof.

    Isala Klieniken, Zwolle, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 21, 2007

Study Start

March 1, 2007

Primary Completion

October 1, 2007

Study Completion

November 1, 2008

Last Updated

May 7, 2012

Record last verified: 2008-05

Locations

NL(3)CH(12)