CClinicalTrials.gg
CompletedNCT00312806Updated May 7, 2012

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

A Phase 3 interventional study of Pantoprazole in Gastroesophageal Reflux Disease (GERD), sponsored by Takeda. Completed at 186 sites in 22 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-07.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,000
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Gastroesophageal Reflux Disease (GERD)

Keywords

  • Gastroesophageal Reflux Disease
  • GERD
  • Pantoprazole
  • ReQuestTM
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Interventions

  • DrugPantoprazole

    Pantoprazole 40 mg o.d.

06

What researchers measure

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 4 and 8 weeks

  2. Investigator assessment

    Time frame: 4 and 8 weeks

  3. Safety and efficacy

    Time frame: 4 and 8 weeks

07

Study locations

186 sites
  • Altana Pharma/Nycomed
    Buenos Aires, 1161, Argentina
  • Altana Pharma/Nycomed
    Buenos Aires, 1405, Argentina
  • Altana Pharma/Nycomed
    Buenos Aires, Argentina
  • Altana Pharma/Nycomed
    La Plata, 1900, Argentina
  • Altana Pharma/Nycomed
    Bedford Park SA, 5042, Australia
  • Altana Pharma/Nycomed
    Bondi Junction, NSW 2022, Australia
  • Altana Pharma/Nycomed
    Fitzroy, VIC 3065, Australia
  • Altana Pharma/Nycomed
    Footscray, VIC 3011, Australia
  • Altana Pharma/Nycomed
    Fremantle, WA, 6959, Australia
  • Altana Pharma/Nycomed
    Kippa_ring, QLD 4021, Australia
  • Altana Pharma/Nycomed
    Melbourne, VIC 3050, Australia
  • Altana Pharma/Nycomed
    NSW, 2310, Australia
  • Altana Pharma/Nycomed
    Penrith, NSW, Australia
  • Altana Pharma/Nycomed
    Phrahran, VIC 3181, Australia
  • Altana Pharma/Nycomed
    Deutschlandsberg, 8539, Austria
  • Altana Pharma/Nycomed
    Feldbach, 8330, Austria
  • Altana Pharma/Nycomed
    Graz, 8010, Austria
  • Altana Pharma/Nycomed
    Krems a. d. Donau, 3500, Austria
  • Altana Pharma/Nycomed
    Lilienfeld, 3180, Austria
  • Altana Pharma/Nycomed
    St. Pölten, 3100, Austria
  • Altana Pharma/Nycomed
    Wien, 1100, Austria
  • Altana Pharma/Nycomed
    Wien, 1130, Austria
  • Altana Pharma/Nycomed
    Wien, 1140, Austria
  • Altana Pharma/Nycomed
    Wien, 1160, Austria
  • Altana Pharma/Nycomed
    Wien, 1170, Austria
  • Altana Pharma/Nycomed
    Wien, 1220, Austria
  • Altana Pharma/Nycomed
    Bouge, 5004, Belgium
  • Altana Pharma/Nycomed
    Brussels, 1000, Belgium
  • Altana Pharma/Nycomed
    Bruxelles, 1020, Belgium
  • Altana Pharma/Nycomed
    Bruxelles, 1040, Belgium
  • Altana Pharma/Nycomed
    Bruxelles, 1070, Belgium
  • Altana Pharma/Nycomed
    Edegem, 2650, Belgium
  • Altana Pharma/Nycomed
    Eupen, 4700, Belgium
  • Altana Pharma/Nycomed
    Gent, 9000, Belgium
  • Altana Pharma/Nycomed
    Jette, 1090, Belgium
  • Altana Pharma/Nycomed
    Kortrijk, 8500, Belgium
  • Altana Pharma/Nycomed
    Leuven, 3000, Belgium
  • Altana Pharma/Nycomed
    Merksem, 2170, Belgium
  • Altana Pharma/Nycomed
    Oostende, 8400, Belgium
  • Altana Pharma/Nycomed
    Sart-Tilman/Liege 1, 4000, Belgium
  • Altana Pharma/Nycomed
    St. Niklaas, 9100, Belgium
  • Altana Pharma/Nycomed
    Belo Horizonte - Minas Gerais, 30130100, Brazil
  • Altana Pharma/Nycomed
    Botucatu - SP CEP, 16618000, Brazil
  • Altana Pharma/Nycomed
    Campinas - Sao Paulo, 13070040, Brazil
  • Altana Pharma/Nycomed
    Campinas /SP, Brazil
  • Altana Pharma/Nycomed
    Curitiba-PR, 80060900, Brazil
  • Altana Pharma/Nycomed
    Ilha do Fundao - Rio de Janeiro - RJ, 21941590, Brazil
  • Altana Pharma/Nycomed
    Pinheiros Sao Paulo - SP, 1246-000, Brazil
  • Altana Pharma/Nycomed
    Porto Alegre - RS, 90035003, Brazil
  • Altana Pharma/Nycomed
    Porto Alegre-RS, 90020090, Brazil
  • Altana Pharma/Nycomed
    Porto Alegre, Brazil
  • Altana Pharma/Nycomed
    Ribeirao Preto-SP, 14048900, Brazil
  • Altana Pharma/Nycomed
    Abbotsford, BC, V2S 3N5, Canada
  • Altana Pharma/Nycomed
    Calgary, T2N 4N1, Canada
  • Altana Pharma/Nycomed
    Hamilton, L8N 4A6, Canada
  • Altana Pharma/Nycomed
    London, N6A 4G5, Canada
  • Altana Pharma/Nycomed
    Montreal, QC, H3A 1A1, Canada
  • Altana Pharma/Nycomed
    Montreal, H3G 1A4, Canada
  • Altana Pharma/Nycomed
    Quebec, H9R 3J1, Canada
  • Altana Pharma/Nycomed
    St.-Charles Borromee, QC, J6E 2C3, Canada
  • Altana Pharma/Nycomed
    Ste Foy, G1S 4L8, Canada
  • Altana Pharma/Nycomed
    Toronto, M3N 2V7, Canada
  • Altana Pharma/Nycomed
    Toronto, M5B 1W8, Canada
  • Altana Pharma/Nycomed
    Windsor, N9A 1C9, Canada
  • Altana Pharma/Nycomed
    Winnipeg, R3A 1R9, Canada
  • Altana Pharma/Nycomed
    Agen, 47000, France
  • Altana Pharma/Nycomed
    Bobigny, 93000, France
  • Altana Pharma/Nycomed
    Hagondange, 57300, France
  • Altana Pharma/Nycomed
    Joue les Tours, 37300, France
  • Altana Pharma/Nycomed
    Lamballe, 22400, France
  • Altana Pharma/Nycomed
    Marseille, 13013, France
  • Altana Pharma/Nycomed
    Metz, 57000, France
  • Altana Pharma/Nycomed
    Orthez, 64300, France
  • Altana Pharma/Nycomed
    Saint-Mande, 94160, France
  • Altana Pharma/Nycomed
    Toulouse, 31000, France
  • Altana Pharma/Nycomed
    Toul, 54200, France
  • Altana Pharma/Nycomed
    Troyes, 10000, France
  • Altana Pharma/Nycomed
    Bonn, 53173, Germany
  • Altana Pharma/Nycomed
    Burg, 39288, Germany
  • Altana Pharma/Nycomed
    Gardelegen, 39638, Germany
  • Altana Pharma/Nycomed
    Heilbronn, 74081, Germany
  • Altana Pharma/Nycomed
    Hennef, 53773, Germany
  • Altana Pharma/Nycomed
    Ludwigsburg, 71640, Germany
  • Altana Pharma/Nycomed
    Lübeck, 23552, Germany
  • Altana Pharma/Nycomed
    Magdeburg, 39130, Germany
  • Altana Pharma/Nycomed
    Schwerin, 19053, Germany
  • Altana Pharma/Nycomed
    Hong Kong, Hong Kong
  • Altana Pharma/Nycomed
    Coimbatore, 641004, India
  • Altana Pharma/Nycomed
    Coimbatore, 641018, India
  • Altana Pharma/Nycomed
    Hyderabad, 500082, India
  • Altana Pharma/Nycomed
    Jaipur, India
  • Altana Pharma/Nycomed
    Madurai, 625002, India
  • Altana Pharma/Nycomed
    Mumbai, 400 008, India
  • Altana Pharma/Nycomed
    Mumbai, 400022, India
  • Altana Pharma/Nycomed
    Mysore, 570020, India
  • Altana Pharma/Nycomed
    Nagpur, 12, India
  • Altana Pharma/Nycomed
    Pune, 411 030, India
  • Altana Pharma/Nycomed
    Pune, 411004, India
  • Altana Pharma/Nycomed
    Aviano (Pordenone), 33081, Italy
  • Altana Pharma/Nycomed
    Bari, 70124, Italy

Showing the first 100 of 186 sites across 22 countries.

08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00312806
Lead sponsor
Takeda
First posted
Apr 11, 2006
Start date
May 2006
Primary completion
Mar 2007
Completion
Jul 2007
Last update
May 7, 2012

Study contacts

Hans-Joachim Ulmer, MD
principal investigator · Medical practice, D-71640 Ludwigsburg, Germany
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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