NCT00282555

Brief Summary

STU-Na belongs to the proton pump inhibitors (PPI), a group of drugs that reduce gastric acidity. PPI are used to treat acid related diseases like erosive or ulcerative esophagitis. This trial aims to find out the therapeutic dose of STU-Na required for healing patients with erosive or ulcerative esophagitis. One of four dosages of STU-Na (15 mg, 30 mg, 60 mg, or 90 mg daily), or Esomeprazole 40 mg daily, an already marketed PPI, will be given to patients. The attribution to one of the 5 treatment groups will be by chance. Neither the patient nor the study physician will know, which treatment is administered to the patient.

Trial Health

40
At Risk

Trial Health Score

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

Trial recruitment is currently suspended
Enrollment
450

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

17 active sites

Status
suspended

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

First Submitted

Initial submission to the registry

January 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2006

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
Last Updated

March 19, 2008

Status Verified

March 1, 2008

First QC Date

January 25, 2006

Last Update Submit

March 18, 2008

Conditions

Esophagitis, Reflux

Keywords

Esophagitis, RefluxS-Tenatoprazole-NaHeartburnEsophageal endoscopy

Outcome Measures

Primary Outcomes (1)

  • Esophageal endoscopy: assessment of achievement of grade "not present" in the Los Angeles scale of esophagitis after two weeks of treatment

Secondary Outcomes (2)

  • Esophageal endoscopy: assessment of achievement of grade "not present" in the Los Angeles scale of esophagitis after four weeks of treatment.

  • Assessment of complete relief of heartburn

Interventions

S-Tenatoprazole-Na (STU-Na)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female outpatients aged 18 to 75 years inclusive
  • Symptomatic ulcerative or erosive esophagitis
  • Presence of heartburn (daytime and/or nighttime).
  • Understanding the study and agreeing to give a written informed consent
  • Able to communicate well with the investigator him(her)self or his/her representatives
  • Able and agreeing to comply with all study requirements

You may not qualify if:

  • gastrointestinal bleeding
  • gastric or esophageal surgery
  • Zollinger-Ellison syndrome
  • primary esophageal motility disorders,
  • esophageal stricture,
  • inflammatory bowel disease,
  • upper gastrointestinal malignancy,
  • pancreatitis,
  • malabsorption
  • Barrett's esophagus (\> 3 cm)
  • Severe disease/condition such as malignancy
  • Hypersensitivity to PPIs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Calgary, Alberta, Canada

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Abbottsford, British Columbia, Canada

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Winnipeg, Manitoba, Canada

Location

Unknown Facility

Guelph, Ontario, Canada

Location

Unknown Facility

Hamilton, Ontario, Canada

Location

Unknown Facility

Scarborough Village, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Windsor, Ontario, Canada

Location

Unknown Facility

Lévis, Quebec, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Pointe-Claire, Quebec, Canada

Location

Unknown Facility

Québec, Quebec, Canada

Location

Unknown Facility

Sherbrooke, Quebec, Canada

Location

Unknown Facility

St-Charles-de-Borromée, Quebec, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, Canada

Location

Related Publications (14)

  • Armstrong D. Review article: gastric pH -- the most relevant predictor of benefit in reflux disease? Aliment Pharmacol Ther. 2004 Oct;20 Suppl 5:19-26; discussion 38-9. doi: 10.1111/j.1365-2036.2004.02140.x.

    PMID: 15456460BACKGROUND

  • Bell NJ, Burget D, Howden CW, Wilkinson J, Hunt RH. Appropriate acid suppression for the management of gastro-oesophageal reflux disease. Digestion. 1992;51 Suppl 1:59-67. doi: 10.1159/000200917.

    PMID: 1397746BACKGROUND

  • Burget DW, Chiverton SG, Hunt RH. Is there an optimal degree of acid suppression for healing of duodenal ulcers? A model of the relationship between ulcer healing and acid suppression. Gastroenterology. 1990 Aug;99(2):345-51. doi: 10.1016/0016-5085(90)91015-x.

    PMID: 2142113BACKGROUND

  • DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. The Practice Parameters Committee of the American College of Gastroenterology. Am J Gastroenterol. 1999 Jun;94(6):1434-42. doi: 10.1111/j.1572-0241.1999.1123_a.x. No abstract available.

    PMID: 10364004BACKGROUND

  • Galmiche JP, Bruley Des Varannes S, Ducrotte P, Sacher-Huvelin S, Vavasseur F, Taccoen A, Fiorentini P, Homerin M. Tenatoprazole, a novel proton pump inhibitor with a prolonged plasma half-life: effects on intragastric pH and comparison with esomeprazole in healthy volunteers. Aliment Pharmacol Ther. 2004 Mar 15;19(6):655-62. doi: 10.1111/j.1365-2036.2004.01893.x.

    PMID: 15023167BACKGROUND

  • Horn J. The proton-pump inhibitors: similarities and differences. Clin Ther. 2000 Mar;22(3):266-80; discussion 265. doi: 10.1016/S0149-2918(00)80032-6.

    PMID: 10963283BACKGROUND

  • Hunt RH, Armstrong D, James C, Chowdhury SK, Yuan Y, Fiorentini P, Taccoen A, Cohen P. Effect on intragastric pH of a PPI with a prolonged plasma half-life: comparison between tenatoprazole and esomeprazole on the duration of acid suppression in healthy male volunteers. Am J Gastroenterol. 2005 Sep;100(9):1949-56. doi: 10.1111/j.1572-0241.2005.41956.x.

    PMID: 16128938BACKGROUND

  • Kakinoki B, Ono C, Yamazaki N, Chikamatsu N, Wakatsuki D, Uchiyama K, Morinaka Y. General pharmacological properties of the new proton pump inhibitor (+/-)-5-methoxy-2-[[(4-methoxy-3,5-dimethylpyrid-2-yl)methyl]sulf inyl]- 1H-imidazo[4,5-b]pyridine. Methods Find Exp Clin Pharmacol. 1999 Apr;21(3):179-87. doi: 10.1358/mf.1999.21.3.534827.

    PMID: 10389120BACKGROUND

  • Katz PO, Castell DO, Chen Y, Andersson T, Sostek MB. Intragastric acid suppression and pharmacokinetics of twice-daily esomeprazole: a randomized, three-way crossover study. Aliment Pharmacol Ther. 2004 Aug 15;20(4):399-406. doi: 10.1111/j.1365-2036.2004.02079.x.

    PMID: 15298633BACKGROUND

  • Kromer W, Horbach S, Luhmann R. Relative efficacies of gastric proton pump inhibitors: their clinical and pharmacological basis. Pharmacology. 1999 Aug;59(2):57-77. doi: 10.1159/000028306.

    PMID: 10450061BACKGROUND

  • Lundell LR, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999 Aug;45(2):172-80. doi: 10.1136/gut.45.2.172.

    PMID: 10403727BACKGROUND

  • Revicki DA, Crawley JA, Zodet MW, Levine DS, Joelsson BO. Complete resolution of heartburn symptoms and health-related quality of life in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 1999 Dec;13(12):1621-30. doi: 10.1046/j.1365-2036.1999.00669.x.

    PMID: 10594397BACKGROUND

  • Stedman CA, Barclay ML. Review article: comparison of the pharmacokinetics, acid suppression and efficacy of proton pump inhibitors. Aliment Pharmacol Ther. 2000 Aug;14(8):963-78. doi: 10.1046/j.1365-2036.2000.00788.x.

    PMID: 10930890BACKGROUND

  • Uchiyama K, Wakatsuki D, Kakinoki B, Takeuchi Y, Araki T, Morinaka Y. The long-lasting effect of TU-199, a novel H+, K(+)-ATPase inhibitor, on gastric acid secretion in dogs. J Pharm Pharmacol. 1999 Apr;51(4):457-64. doi: 10.1211/0022357991772510.

    PMID: 10385219BACKGROUND

MeSH Terms

Conditions

Esophagitis, PepticHeartburn

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alan Thomson, MD, Prof.

    University of Alberta, Division of Gastroenterology, Department of Medicine, Edmonton, Alberta, Canada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 26, 2006

Study Start

February 1, 2006

Last Updated

March 19, 2008

Record last verified: 2008-03

Locations

CA(17)