Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)

May 4, 2012 updated by: Takeda

Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks

The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1161
        • Altana Pharma/Nycomed
      • Buenos Aires, Argentina, 1405
        • Altana Pharma/Nycomed
      • Buenos Aires, Argentina
        • Altana Pharma/Nycomed
      • La Plata, Argentina, 1900
        • Altana Pharma/Nycomed
  • Australia
      • Bedford Park SA, Australia, 5042
        • Altana Pharma/Nycomed
      • Bondi Junction, Australia, NSW 2022
        • Altana Pharma/Nycomed
      • Fitzroy, Australia, VIC 3065
        • Altana Pharma/Nycomed
      • Footscray, Australia, VIC 3011
        • Altana Pharma/Nycomed
      • Fremantle, WA, Australia, 6959
        • Altana Pharma/Nycomed
      • Kippa_ring, Australia, QLD 4021
        • Altana Pharma/Nycomed
      • Melbourne, Australia, VIC 3050
        • Altana Pharma/Nycomed
      • NSW, Australia, 2310
        • Altana Pharma/Nycomed
      • Penrith, NSW, Australia
        • Altana Pharma/Nycomed
      • Phrahran, Australia, VIC 3181
        • Altana Pharma/Nycomed
  • Austria
      • Deutschlandsberg, Austria, 8539
        • Altana Pharma/Nycomed
      • Feldbach, Austria, 8330
        • Altana Pharma/Nycomed
      • Graz, Austria, 8010
        • Altana Pharma/Nycomed
      • Krems a. d. Donau, Austria, 3500
        • Altana Pharma/Nycomed
      • Lilienfeld, Austria, 3180
        • Altana Pharma/Nycomed
      • St. Pölten, Austria, 3100
        • Altana Pharma/Nycomed
      • Wien, Austria, 1130
        • Altana Pharma/Nycomed
      • Wien, Austria, 1140
        • Altana Pharma/Nycomed
      • Wien, Austria, 1170
        • Altana Pharma/Nycomed
      • Wien, Austria, 1100
        • Altana Pharma/Nycomed
      • Wien, Austria, 1160
        • Altana Pharma/Nycomed
      • Wien, Austria, 1220
        • Altana Pharma/Nycomed
  • Belgium
      • Bouge, Belgium, 5004
        • Altana Pharma/Nycomed
      • Brussels, Belgium, 1000
        • Altana Pharma/Nycomed
      • Bruxelles, Belgium, 1020
        • Altana Pharma/Nycomed
      • Bruxelles, Belgium, 1040
        • Altana Pharma/Nycomed
      • Bruxelles, Belgium, 1070
        • Altana Pharma/Nycomed
      • Edegem, Belgium, 2650
        • Altana Pharma/Nycomed
      • Eupen, Belgium, 4700
        • Altana Pharma/Nycomed
      • Gent, Belgium, 9000
        • Altana Pharma/Nycomed
      • Jette, Belgium, 1090
        • Altana Pharma/Nycomed
      • Kortrijk, Belgium, 8500
        • Altana Pharma/Nycomed
      • Leuven, Belgium, 3000
        • Altana Pharma/Nycomed
      • Merksem, Belgium, 2170
        • Altana Pharma/Nycomed
      • Oostende, Belgium, 8400
        • Altana Pharma/Nycomed
      • Sart-Tilman/Liege 1, Belgium, 4000
        • Altana Pharma/Nycomed
      • St. Niklaas, Belgium, 9100
        • Altana Pharma/Nycomed
  • Brazil
      • Belo Horizonte - Minas Gerais, Brazil, 30130100
        • Altana Pharma/Nycomed
      • Botucatu - SP CEP, Brazil, 16618000
        • Altana Pharma/Nycomed
      • Campinas - Sao Paulo, Brazil, 13070040
        • Altana Pharma/Nycomed
      • Campinas /SP, Brazil
        • Altana Pharma/Nycomed
      • Curitiba-PR, Brazil, 80060900
        • Altana Pharma/Nycomed
      • Ilha do Fundao - Rio de Janeiro - RJ, Brazil, 21941590
        • Altana Pharma/Nycomed
      • Pinheiros Sao Paulo - SP, Brazil, 1246-000
        • Altana Pharma/Nycomed
      • Porto Alegre, Brazil
        • Altana Pharma/Nycomed
      • Porto Alegre - RS, Brazil, 90035003
        • Altana Pharma/Nycomed
      • Porto Alegre-RS, Brazil, 90020090
        • Altana Pharma/Nycomed
      • Ribeirao Preto-SP, Brazil, 14048900
        • Altana Pharma/Nycomed
  • Canada
      • Abbotsford, BC, Canada, V2S 3N5
        • Altana Pharma/Nycomed
      • Calgary, Canada, T2N 4N1
        • Altana Pharma/Nycomed
      • Hamilton, Canada, L8N 4A6
        • Altana Pharma/Nycomed
      • London, Canada, N6A 4G5
        • Altana Pharma/Nycomed
      • Montreal, Canada, H3G 1A4
        • Altana Pharma/Nycomed
      • Montreal, QC, Canada, H3A 1A1
        • Altana Pharma/Nycomed
      • Quebec, Canada, H9R 3J1
        • Altana Pharma/Nycomed
      • St.-Charles Borromee, QC, Canada, J6E 2C3
        • Altana Pharma/Nycomed
      • Ste Foy, Canada, G1S 4L8
        • Altana Pharma/Nycomed
      • Toronto, Canada, M3N 2V7
        • Altana Pharma/Nycomed
      • Toronto, Canada, M5B 1W8
        • Altana Pharma/Nycomed
      • Windsor, Canada, N9A 1C9
        • Altana Pharma/Nycomed
      • Winnipeg, Canada, R3A 1R9
        • Altana Pharma/Nycomed
  • France
      • Agen, France, 47000
        • Altana Pharma/Nycomed
      • Bobigny, France, 93000
        • Altana Pharma/Nycomed
      • Hagondange, France, 57300
        • Altana Pharma/Nycomed
      • Joue les Tours, France, 37300
        • Altana Pharma/Nycomed
      • Lamballe, France, 22400
        • Altana Pharma/Nycomed
      • Marseille, France, 13013
        • Altana Pharma/Nycomed
      • Metz, France, 57000
        • Altana Pharma/Nycomed
      • Orthez, France, 64300
        • Altana Pharma/Nycomed
      • Saint-Mande, France, 94160
        • Altana Pharma/Nycomed
      • Toul, France, 54200
        • Altana Pharma/Nycomed
      • Toulouse, France, 31000
        • Altana Pharma/Nycomed
      • Troyes, France, 10000
        • Altana Pharma/Nycomed
  • Germany
      • Bonn, Germany, 53173
        • Altana Pharma/Nycomed
      • Burg, Germany, 39288
        • Altana Pharma/Nycomed
      • Gardelegen, Germany, 39638
        • Altana Pharma/Nycomed
      • Heilbronn, Germany, 74081
        • Altana Pharma/Nycomed
      • Hennef, Germany, 53773
        • Altana Pharma/Nycomed
      • Ludwigsburg, Germany, 71640
        • Altana Pharma/Nycomed
      • Lübeck, Germany, 23552
        • Altana Pharma/Nycomed
      • Magdeburg, Germany, 39130
        • Altana Pharma/Nycomed
      • Schwerin, Germany, 19053
        • Altana Pharma/Nycomed
  • Hong Kong
      • Hong Kong, Hong Kong
        • Altana Pharma/Nycomed
  • India
      • Coimbatore, India, 641004
        • Altana Pharma/Nycomed
      • Coimbatore, India, 641018
        • Altana Pharma/Nycomed
      • Hyderabad, India, 500082
        • Altana Pharma/Nycomed
      • Jaipur, India
        • Altana Pharma/Nycomed
      • Madurai, India, 625002
        • Altana Pharma/Nycomed
      • Mumbai, India, 400 008
        • Altana Pharma/Nycomed
      • Mumbai, India, 400022
        • Altana Pharma/Nycomed
      • Mysore, India, 570020
        • Altana Pharma/Nycomed
      • Nagpur, India, 12
        • Altana Pharma/Nycomed
      • Pune, India, 411 030
        • Altana Pharma/Nycomed
      • Pune, India, 411004
        • Altana Pharma/Nycomed
  • Italy
      • Aviano (Pordenone), Italy, 33081
        • Altana Pharma/Nycomed
      • Bari, Italy, 70124
        • Altana Pharma/Nycomed
      • Caserta, Italy, 81100
        • Altana Pharma/Nycomed
      • Catania, Italy, 95123
        • Altana Pharma/Nycomed
      • Genova, Italy, 16132
        • Altana Pharma/Nycomed
      • Mestre (VE), Italy, 30174
        • Altana Pharma/Nycomed
      • Milano, Italy, 20147
        • Altana Pharma/Nycomed
      • Napoli, Italy, 80131
        • Altana Pharma/Nycomed
      • Parma, Italy, 43100
        • Altana Pharma/Nycomed
      • Roma, Italy, 133
        • Altana Pharma/Nycomed
      • Roma, Italy, 135
        • Altana Pharma/Nycomed
      • Roma, Italy, 189
        • Altana Pharma/Nycomed
      • Rozzano (Milano), Italy, 20089
        • Altana Pharma/Nycomed
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 135-710
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 135-720
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 137-040
        • Altana Pharma/Nycomed
      • Seoul, Korea, Republic of, 138-736
        • Altana Pharma/Nycomed
  • Malaysia
      • Kota Kinabalu, Sabah, Malaysia, 88586
        • Altana Pharma/Nycomed
      • Kuala Lumpur, Malaysia, 50603
        • Altana Pharma/Nycomed
  • Mexico
      • Col Del Valle, México D.F., Mexico, 3100
        • Altana Pharma/Nycomed
      • Col Del Valle, México D.F., Mexico, 6760
        • Altana Pharma/Nycomed
      • Col Héroes de Padierna, México D.F., Mexico, 10700
        • Altana Pharma/Nycomed
      • Col. Altavista,Tampico Tamaulipas,Mexico, Mexico, 89240
        • Altana Pharma/Nycomed
      • Col. Ex Hacienda Coapa Mexico D.F., Mexico, 4860
        • Altana Pharma/Nycomed
      • Héroes de Padierna, México D.F., Mexico, 3100
        • Altana Pharma/Nycomed
      • León, Guanajuato, Mexico, 37320
        • Altana Pharma/Nycomed
      • León, Guanajuato Mexico, Mexico, 36000
        • Altana Pharma/Nycomed
      • Lomas de Chapultepec, México D.F., Mexico, 11000
        • Altana Pharma/Nycomed
      • México, D.F., Mexico, 3100
        • Altana Pharma/Nycomed
      • Villahermosa, Tabasco, Mexico, 86000
        • Altana Pharma/Nycomed
      • Villahermosa, Tabasco, Mexico, 86085
        • Altana Pharma/Nycomed
  • Poland
      • Bialystok, Poland, 15-276
        • Altana Pharma/Nycomed
      • Katowice, Poland, 40-752
        • Altana Pharma/Nycomed
      • Lodz, Poland, 90-153
        • Altana Pharma/Nycomed
      • Warszawa, Poland, 02-097
        • Altana Pharma/Nycomed
      • Warszawa, Poland, 02-507
        • Altana Pharma/Nycomed
  • Portugal
      • Amadora, Portugal, 2720-276
        • Altana Pharma/Nycomed
      • Carnaxide, Portugal, 2799-523
        • Altana Pharma/Nycomed
      • Coimbra, Portugal, 3001
        • Altana Pharma/Nycomed
      • Lisboa, Portugal, 1099-023
        • Altana Pharma/Nycomed
      • Lisboa, Portugal, 1349-019
        • Altana Pharma/Nycomed
      • Lisboa, Portugal, 1769-053
        • Altana Pharma/Nycomed
      • Santarém, Portugal, 2005-177
        • Altana Pharma/Nycomed
      • Setúbal, Portugal, 2910-446
        • Altana Pharma/Nycomed
      • Viana do Castelo, Portugal, 4900-858
        • Altana Pharma/Nycomed
      • Vila Nova de Gaia, Portugal, 4400-346
        • Altana Pharma/Nycomed
  • Singapore
      • Singapore, Singapore, 1699608
        • Altana Pharma/Nycomed
  • South Africa
      • Amanzimtoti, South Africa, 4126
        • Altana Pharma/Nycomed
      • Berea, Durban, South Africa, 4000
        • Altana Pharma/Nycomed
      • Bloemfontein, South Africa, 9317
        • Altana Pharma/Nycomed
      • Cape Town, South Africa, 7530
        • Altana Pharma/Nycomed
      • Panorama, South Africa, 7500
        • Altana Pharma/Nycomed
      • Port Elizabeth, South Africa, 6001
        • Altana Pharma/Nycomed
      • Pretoria, South Africa, 48
        • Altana Pharma/Nycomed
      • Somerset-West, South Africa, 7130
        • Altana Pharma/Nycomed
  • Spain
      • Barcelona, Spain, 8017
        • Altana Pharma/Nycomed
      • Barcelona, Spain, 8222
        • Altana Pharma/Nycomed
      • Castellón de la Plana, Spain, 12004
        • Altana Pharma/Nycomed
      • Cordoba, Spain, 14004
        • Altana Pharma/Nycomed
      • Cádiz, Spain, 11009
        • Altana Pharma/Nycomed
      • Granada, Spain, 18014
        • Altana Pharma/Nycomed
      • Madrid, Spain, 28046
        • Altana Pharma/Nycomed
      • Madrid, Spain, 28035
        • Altana Pharma/Nycomed
      • Madrid, Spain, 28200
        • Altana Pharma/Nycomed
      • Pamplona, Spain, 31080
        • Altana Pharma/Nycomed
      • Ribeira, Spain, 15993
        • Altana Pharma/Nycomed
      • Sevilla, Spain, 41014
        • Altana Pharma/Nycomed
  • Switzerland
      • Basel, Switzerland, 4031
        • Altana Pharma/Nycomed
      • Biasca, Switzerland, 6710
        • Altana Pharma/Nycomed
      • Biel/Bienne, Switzerland, 2502
        • Altana Pharma/Nycomed
      • Lausanne 11 VD, Switzerland, 1011
        • Altana Pharma/Nycomed
      • Liestal, Switzerland, 4410
        • Altana Pharma/Nycomed
      • Locarno, TI., Switzerland, 6600
        • Altana Pharma/Nycomed
      • Luzern, Switzerland, 6003
        • Altana Pharma/Nycomed
      • Payerne, Switzerland, 1530
        • Altana Pharma/Nycomed
      • Thun, Switzerland, 3600
        • Altana Pharma/Nycomed
      • Zürich, Switzerland, 8002
        • Altana Pharma/Nycomed
      • Zürich, Switzerland, 8050
        • Altana Pharma/Nycomed
  • Taiwan
      • Taichung, Taiwan, 40705
        • Altana Pharma/Nycomed
      • Tainan, Taiwan, 701
        • Altana Pharma/Nycomed
      • Taipei, Taiwan
        • Altana Pharma/Nycomed
  • United Kingdom
      • Bath, United Kingdom, BA1 2SR
        • Altana Pharma/Nycomed
      • Blackpool, United Kingdom, FY3 7EN
        • Altana Pharma/Nycomed
      • Glasgow, United Kingdom, G45 9AW
        • Altana Pharma/Nycomed
      • Middlesex, United Kingdom, HA6 2RN
        • Altana Pharma/Nycomed
      • Sheffield, United Kingdom, S5 7QB
        • Altana Pharma/Nycomed
      • Trowbridge, United Kingdom, BA14 9AR
        • Altana Pharma/Nycomed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Written informed consent
  • Outpatients of at least 18 years (21 years in Argentina)
  • Patient considered to have GERD symptoms

Main Exclusion Criteria:

  • Acute peptic ulcer and/or ulcer complications
  • Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) during the last 28 days before study start (except regular intake of acetylsalicylic acid at a dose up to 163 mg/day)
  • Intake of proton pump inhibitors during the last 10 days before study start
  • Female patients of childbearing potential not using adequate means of birth control
  • Pregnant or breast-feeding females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™
Time Frame: 4 and 8 weeks
4 and 8 weeks
Investigator assessment
Time Frame: 4 and 8 weeks
4 and 8 weeks
Safety and efficacy
Time Frame: 4 and 8 weeks
4 and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hans-Joachim Ulmer, MD, Medical practice, D-71640 Ludwigsburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BY1023/M3-341

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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