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Gastroesophageal Reflux Disease (GERD)Phase 3NCT00312806

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

A Phase 3 study testing Pantoprazole in people with Gastroesophageal Reflux Disease (GERD), run by Takeda at 186 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastroesophageal Reflux Disease (GERD)
What is being tested?
Pantoprazole
How many people
2,000 participants
Where
186 sitesin 22 countries
Study dates
May 2006to Jul 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

186 sites in 22 countries.

186 sites in 22 countries

Belgium15 sites

  • Altana Pharma/Nycomed

    Bouge, 5004

  • Altana Pharma/Nycomed

    Brussels, 1000

  • Altana Pharma/Nycomed

    Brussels, 1020

  • Altana Pharma/Nycomed

    Brussels, 1040

  • Altana Pharma/Nycomed

    Brussels, 1070

  • Altana Pharma/Nycomed

    Edegem, 2650

  • Altana Pharma/Nycomed

    Eupen, 4700

  • Altana Pharma/Nycomed

    Ghent, 9000

  • Altana Pharma/Nycomed

    Jette, 1090

  • Altana Pharma/Nycomed

    Kortrijk, 8500

  • Altana Pharma/Nycomed

    Leuven, 3000

  • Altana Pharma/Nycomed

    Merksem, 2170

  • Altana Pharma/Nycomed

    Ostend, 8400

  • Altana Pharma/Nycomed

    Saint Niklaas, 9100

  • Altana Pharma/Nycomed

    Sart-Tilman/Liege 1, 4000

Other trials in Belgium

Canada13 sites

  • Altana Pharma/Nycomed

    Abbotsford, BC, V2S 3N5

  • Altana Pharma/Nycomed

    Calgary, T2N 4N1

  • Altana Pharma/Nycomed

    Hamilton, L8N 4A6

  • Altana Pharma/Nycomed

    London, N6A 4G5

  • Altana Pharma/Nycomed

    Montreal, H3G 1A4

  • Altana Pharma/Nycomed

    Montreal, QC, H3A 1A1

  • Altana Pharma/Nycomed

    Québec, H9R 3J1

  • Altana Pharma/Nycomed

    St.-Charles Borromee, QC, J6E 2C3

  • Altana Pharma/Nycomed

    Ste Foy, G1S 4L8

  • Altana Pharma/Nycomed

    Toronto, M3N 2V7

  • Altana Pharma/Nycomed

    Toronto, M5B 1W8

  • Altana Pharma/Nycomed

    Windsor, N9A 1C9

  • Altana Pharma/Nycomed

    Winnipeg, R3A 1R9

Other trials in Canada

Italy13 sites

  • Altana Pharma/Nycomed

    Aviano (Pordenone), 33081

  • Altana Pharma/Nycomed

    Bari, 70124

  • Altana Pharma/Nycomed

    Caserta, 81100

  • Altana Pharma/Nycomed

    Catania, 95123

  • Altana Pharma/Nycomed

    Genova, 16132

  • Altana Pharma/Nycomed

    Mestre (VE), 30174

  • Altana Pharma/Nycomed

    Milan, 20147

  • Altana Pharma/Nycomed

    Naples, 80131

  • Altana Pharma/Nycomed

    Parma, 43100

  • Altana Pharma/Nycomed

    Roma, 133

  • Altana Pharma/Nycomed

    Roma, 135

  • Altana Pharma/Nycomed

    Roma, 189

  • Altana Pharma/Nycomed

    Rozzano (Milano), 20089

Other trials in Italy

Austria12 sites

  • Altana Pharma/Nycomed

    Deutschlandsberg, 8539

  • Altana Pharma/Nycomed

    Feldbach, 8330

  • Altana Pharma/Nycomed

    Graz, 8010

  • Altana Pharma/Nycomed

    Krems A. D. Donau, 3500

  • Altana Pharma/Nycomed

    Lilienfeld, 3180

  • Altana Pharma/Nycomed

    Sankt Pölten, 3100

  • Altana Pharma/Nycomed

    Vienna, 1100

  • Altana Pharma/Nycomed

    Vienna, 1130

  • Altana Pharma/Nycomed

    Vienna, 1140

  • Altana Pharma/Nycomed

    Vienna, 1160

  • Altana Pharma/Nycomed

    Vienna, 1170

  • Altana Pharma/Nycomed

    Vienna, 1220

Other trials in Austria

France12 sites

  • Altana Pharma/Nycomed

    Agen, 47000

  • Altana Pharma/Nycomed

    Bobigny, 93000

  • Altana Pharma/Nycomed

    Hagondange, 57300

  • Altana Pharma/Nycomed

    Joué-lès-Tours, 37300

  • Altana Pharma/Nycomed

    Lamballe, 22400

  • Altana Pharma/Nycomed

    Marseille, 13013

  • Altana Pharma/Nycomed

    Metz, 57000

  • Altana Pharma/Nycomed

    Orthez, 64300

  • Altana Pharma/Nycomed

    Saint-Mandé, 94160

  • Altana Pharma/Nycomed

    Toul, 54200

  • Altana Pharma/Nycomed

    Toulouse, 31000

  • Altana Pharma/Nycomed

    Troyes, 10000

Other trials in France

Mexico12 sites

  • Altana Pharma/Nycomed

    Col Del Valle, México D.F., 3100

  • Altana Pharma/Nycomed

    Col Del Valle, México D.F., 6760

  • Altana Pharma/Nycomed

    Col Héroes de Padierna, México D.F., 10700

  • Altana Pharma/Nycomed

    Col. Altavista,Tampico Tamaulipas,Mexico, 89240

  • Altana Pharma/Nycomed

    Col. Ex Hacienda Coapa Mexico D.F., 4860

  • Altana Pharma/Nycomed

    Héroes de Padierna, México D.F., 3100

  • Altana Pharma/Nycomed

    León, Guanajuato, 37320

  • Altana Pharma/Nycomed

    León, Guanajuato Mexico, 36000

  • Altana Pharma/Nycomed

    Lomas de Chapultepec, México D.F., 11000

  • Altana Pharma/Nycomed

    México, D.F., 3100

  • Altana Pharma/Nycomed

    Villahermosa, Tabasco, 86000

  • Altana Pharma/Nycomed

    Villahermosa, Tabasco, 86085

Other trials in Mexico

Spain12 sites

  • Altana Pharma/Nycomed

    Barcelona, 8017

  • Altana Pharma/Nycomed

    Barcelona, 8222

  • Altana Pharma/Nycomed

    Cadiz, 11009

  • Altana Pharma/Nycomed

    Castellon, 12004

  • Altana Pharma/Nycomed

    Córdoba, 14004

  • Altana Pharma/Nycomed

    Granada, 18014

  • Altana Pharma/Nycomed

    Madrid, 28035

  • Altana Pharma/Nycomed

    Madrid, 28046

  • Altana Pharma/Nycomed

    Madrid, 28200

  • Altana Pharma/Nycomed

    Pamplona, 31080

  • Altana Pharma/Nycomed

    Ribeira, 15993

  • Altana Pharma/Nycomed

    Seville, 41014

Other trials in Spain

Brazil11 sites

  • Altana Pharma/Nycomed

    Belo Horizonte - Minas Gerais, 30130100

  • Altana Pharma/Nycomed

    Botucatu - SP CEP, 16618000

  • Altana Pharma/Nycomed

    Campinas - Sao Paulo, 13070040

  • Altana Pharma/Nycomed

    Campinas /SP

  • Altana Pharma/Nycomed

    Curitiba-PR, 80060900

  • Altana Pharma/Nycomed

    Ilha Do Fundao - Rio de Janeiro - RJ, 21941590

  • Altana Pharma/Nycomed

    Pinheiros Sao Paulo - SP, 1246-000

  • Altana Pharma/Nycomed

    Porto Alegre

  • Altana Pharma/Nycomed

    Porto Alegre - RS, 90035003

  • Altana Pharma/Nycomed

    Porto Alegre-RS, 90020090

  • Altana Pharma/Nycomed

    Ribeirao Preto-SP, 14048900

Other trials in Brazil

India11 sites

  • Altana Pharma/Nycomed

    Coimbatore, 641004

  • Altana Pharma/Nycomed

    Coimbatore, 641018

  • Altana Pharma/Nycomed

    Hyderabad, 500082

  • Altana Pharma/Nycomed

    Jaipur

  • Altana Pharma/Nycomed

    Madurai, 625002

  • Altana Pharma/Nycomed

    Mumbai, 400 008

  • Altana Pharma/Nycomed

    Mumbai, 400022

  • Altana Pharma/Nycomed

    Mysore, 570020

  • Altana Pharma/Nycomed

    Nagpur, 12

  • Altana Pharma/Nycomed

    Pune, 411 030

  • Altana Pharma/Nycomed

    Pune, 411004

Other trials in India

Switzerland11 sites

  • Altana Pharma/Nycomed

    Basel, 4031

  • Altana Pharma/Nycomed

    Biasca, 6710

  • Altana Pharma/Nycomed

    Biel/Bienne, 2502

  • Altana Pharma/Nycomed

    Lausanne 11 VD, 1011

  • Altana Pharma/Nycomed

    Liestal, 4410

  • Altana Pharma/Nycomed

    Locarno, TI., 6600

  • Altana Pharma/Nycomed

    Lucerne, 6003

  • Altana Pharma/Nycomed

    Payerne, 1530

  • Altana Pharma/Nycomed

    Thun, 3600

  • Altana Pharma/Nycomed

    Zurich, 8002

  • Altana Pharma/Nycomed

    Zurich, 8050

Other trials in Switzerland

Australia10 sites

  • Altana Pharma/Nycomed

    Bedford Park SA, 5042

  • Altana Pharma/Nycomed

    Bondi Junction, NSW 2022

  • Altana Pharma/Nycomed

    Fitzroy, VIC 3065

  • Altana Pharma/Nycomed

    Footscray, VIC 3011

  • Altana Pharma/Nycomed

    Fremantle, WA, 6959

  • Altana Pharma/Nycomed

    Kippa_ring, QLD 4021

  • Altana Pharma/Nycomed

    Melbourne, VIC 3050

  • Altana Pharma/Nycomed

    NSW, 2310

  • Altana Pharma/Nycomed

    Penrith, NSW

  • Altana Pharma/Nycomed

    Phrahran, VIC 3181

Other trials in Australia

Portugal10 sites

  • Altana Pharma/Nycomed

    Amadora, 2720-276

  • Altana Pharma/Nycomed

    Carnaxide, 2799-523

  • Altana Pharma/Nycomed

    Coimbra, 3001

  • Altana Pharma/Nycomed

    Lisbon, 1099-023

  • Altana Pharma/Nycomed

    Lisbon, 1349-019

  • Altana Pharma/Nycomed

    Lisbon, 1769-053

  • Altana Pharma/Nycomed

    Santarém, 2005-177

  • Altana Pharma/Nycomed

    Setúbal, 2910-446

  • Altana Pharma/Nycomed

    Viana do Castelo, 4900-858

  • Altana Pharma/Nycomed

    Vila Nova de Gaia, 4400-346

Other trials in Portugal

Germany9 sites

  • Altana Pharma/Nycomed

    Bonn, 53173

  • Altana Pharma/Nycomed

    Burg, 39288

  • Altana Pharma/Nycomed

    Gardelegen, 39638

  • Altana Pharma/Nycomed

    Heilbronn, 74081

  • Altana Pharma/Nycomed

    Hennef (Sieg), 53773

  • Altana Pharma/Nycomed

    Lübeck, 23552

  • Altana Pharma/Nycomed

    Ludwigsburg, 71640

  • Altana Pharma/Nycomed

    Magdeburg, 39130

  • Altana Pharma/Nycomed

    Schwerin, 19053

Other trials in Germany

South Africa8 sites

  • Altana Pharma/Nycomed

    Berea, Durban, 4000

  • Altana Pharma/Nycomed

    Bloemfontein, 9317

  • Altana Pharma/Nycomed

    Cape Town, 7530

  • Altana Pharma/Nycomed

    eManzimtoti, 4126

  • Altana Pharma/Nycomed

    Panorama, 7500

  • Altana Pharma/Nycomed

    Port Elizabeth, 6001

  • Altana Pharma/Nycomed

    Pretoria, 48

  • Altana Pharma/Nycomed

    Somerset West, 7130

Other trials in South Africa

United Kingdom6 sites

  • Altana Pharma/Nycomed

    Bath, BA1 2SR

  • Altana Pharma/Nycomed

    Blackpool, FY3 7EN

  • Altana Pharma/Nycomed

    Glasgow, G45 9AW

  • Altana Pharma/Nycomed

    Middlesex, HA6 2RN

  • Altana Pharma/Nycomed

    Sheffield, S5 7QB

  • Altana Pharma/Nycomed

    Trowbridge, BA14 9AR

Other trials in United Kingdom

Poland5 sites

  • Altana Pharma/Nycomed

    Bialystok, 15-276

  • Altana Pharma/Nycomed

    Katowice, 40-752

  • Altana Pharma/Nycomed

    Lodz, 90-153

  • Altana Pharma/Nycomed

    Warsaw, 02-097

  • Altana Pharma/Nycomed

    Warsaw, 02-507

Other trials in Poland

South Korea5 sites

  • Altana Pharma/Nycomed

    Seoul, 110-744

  • Altana Pharma/Nycomed

    Seoul, 135-710

  • Altana Pharma/Nycomed

    Seoul, 135-720

  • Altana Pharma/Nycomed

    Seoul, 137-040

  • Altana Pharma/Nycomed

    Seoul, 138-736

Other trials in South Korea

Argentina4 sites

  • Altana Pharma/Nycomed

    Buenos Aires, 1161

  • Altana Pharma/Nycomed

    Buenos Aires, 1405

  • Altana Pharma/Nycomed

    Buenos Aires

  • Altana Pharma/Nycomed

    La Plata, 1900

Other trials in Argentina

Taiwan3 sites

  • Altana Pharma/Nycomed

    Taichung, 40705

  • Altana Pharma/Nycomed

    Tainan, 701

  • Altana Pharma/Nycomed

    Taipei

Other trials in Taiwan

Malaysia2 sites

  • Altana Pharma/Nycomed

    Kota Kinabalu, Sabah, 88586

  • Altana Pharma/Nycomed

    Kuala Lumpur, 50603

Other trials in Malaysia

Hong Kong1 site

  • Altana Pharma/Nycomed

    Hong Kong

Other trials in Hong Kong

Singapore1 site

  • Altana Pharma/Nycomed

    Singapore, 1699608

Other trials in Singapore

About this study

Official title: 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.

Being tested
Pantoprazole
Keywords
Gastroesophageal Reflux Disease, GERD, Pantoprazole, ReQuestTM
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PantoprazoleDrug

    Pantoprazole 40 mg o.d.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™

    Measured: 8 weeks

Secondary outcomes (3)

  1. Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™

    Measured: 4 and 8 weeks

  2. Investigator assessment

    Measured: 4 and 8 weeks

  3. Safety and efficacy

    Measured: 4 and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionMar 2007
  4. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00312806
Sponsor's protocol ID
BY1023/M3-341
Status last verified
Dec 2008
First submitted
10 Apr 2006
Last updated
7 May 2012
Results posted
No

Publications

  • Goh KL, Choi KD, Choi MG, Hsieh TY, Jung HY, Lien HC, Menon J, Mesenas S, Park H, Sheu BS, Wu JC. Factors influencing treatment outcome in patients with gastroesophageal reflux disease: outcome of a prospective pragmatic trial in Asian patients. BMC Gastroenterol. 2014 Sep 9;14:156. doi: 10.1186/1471-230X-14-156.

    PubMed 25200403

  • Heading RC, Monnikes H, Tholen A, Schmitt H. Prediction of response to PPI therapy and factors influencing treatment outcome in patients with GORD: a prospective pragmatic trial using pantoprazole. BMC Gastroenterol. 2011 May 11;11:52. doi: 10.1186/1471-230X-11-52.

    PubMed 21569313

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pantoprazole in people with Gastroesophageal Reflux Disease (GERD), run by Takeda at 186 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 186 sites in Belgium, Canada, Italy, Austria, France and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™ (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00312806, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.

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