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Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
This study is ongoing, but not recruiting participants.
Study NCT00669955   Information provided by Axcan Pharma
First Received: April 29, 2008   Last Updated: June 9, 2009   History of Changes

April 29, 2008
June 9, 2009
June 2008
July 2009   (final data collection date for primary outcome measure)
Helicobacter Pylori Status confirmed by Urea Breath Test [ Time Frame: One month and two months post-treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00669955 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: at the end of treatment, one and two months post-treatment ] [ Designated as safety issue: Yes ]
Same as current
 
Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given X 10 Days With Omeprazole in Eradication of Helicobacter Pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given X 7 Days

This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole) vs triple therapy (amoxicillin, clarithromycin and omeprazole) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed H. pylori positive status will be randomized to one of the treatments described above. Approximately one month and two months after treatment, a urea breath test will be performed to confirm eradication.

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 30 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects assigned to OAC will be treated for 7 days. Those assigned to Pylera will be treated for 10 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 8 and 14.

Follow-up: includes two visits. approximately one and two months post-treatment. Eradication of H. Pylori will be confirmed through Urea Breath Test, and resistance will be evaluated in case of treatment failure. These subjects will undergo an endoscopy.

Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Helicobacter Infections
  • Drug: OBMT
  • Drug: OAC
  • Active Comparator: Triple therapy, consisting of Omeprazole, Amoxicilin and Clarithromycin given for 7 days
  • Experimental: OBMT (Pylera)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
400
August 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Positive H. Pylori status;
  • Presence of upper gastro-intestinal symptoms;
  • Mental and legal ability to sign informed consent.

Exclusion Criteria:

  • Previous surgery of the GI tract;
  • Clinically significant impairment of renal or hepatic function;
  • Severe unstable cardiovascular, pulmonary or endocrine disease;
  • Barrett's oesophagus or high-grade dysplasia;
  • Dysphagia or vomiting as major symptoms.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00669955
Dr. Monique Giguere, Axcan Pharma inc.
PYLHp07-01
Axcan Pharma
 
Study Director: Monique Giguère, PhD Axcan Pharma inc
Axcan Pharma
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP