Skip to main content
OpenTrials
Completed

NCT Number: NCT00669955

Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy

This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) 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. At week 6 and 10 follow-up visits, a urea breath test (UBT) will be performed to confirm eradication.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Helicobacter Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. I. Orpen

Bath, United Kingdom

About this study

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 UBT, and resistance will be evaluated in case of treatment failure. These subjects will undergo an endoscopy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omeprazole, Amoxicillin, Clarithromycin

Drug

Triple therapy given for 7 days at a dose of omeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID

Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole

Drug

Pylera is a three in one capsule containing bismuth subcitrate potassium 120 mg, metronidazole 125 mg and tetracycline 125 mg given as 3 capsules QID, with omeprazole 20 mg BID.

Other names: Pylera

Primary outcomes

  1. Helicobacter Pylori Eradication Confirmed by Urea Breath Test

    Time frame: Week 6 and week 10 follow-up visits

    H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.

Secondary outcomes

  1. Number of Patients Experiencing Treatment Emergent Adverse Events.

    Time frame: at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.

    A treatment-emergent adverse event is defined as an event not present prior to exposure to the study medication or any event already present that worsens in either intensity or frequency following exposure to study medication up to 30 days after study discontinuation.

    All safety analysis based on the safety population.

  2. H. Pylori Eradication and Presence or Past History of Peptic Ulcers

    Time frame: Week 6 and week 10 follow-up visits

    Eradication rates in the subset of patients with peptic ulcer (current or past history) at baseline are reported based on the per protocol population. Eradication must be confirmed at week 6 and week 10 by a negative Urea Breath Test conducted within the allocated windows.

  3. Clarithromycin Resistance

    Time frame: Measured at baseline

    Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to clarithromycin at baseline. Resistance to clarithromycin defined as Minimum Inhibitory Concentration (MIC) of 1 ug/ml and above

  4. Metronidazole Resistance

    Time frame: Measured at baseline

    Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to metronidazole at baseline. Resistance to metronidazole defined as Minimum Inhibitory Concentration (MIC) above 8 ug/ml

  5. Overall Compliance to Study Medications

    Time frame: At the end of the treatment phase (days 8-14)

    Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100. Percentages based on safety population

  6. Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level

    Time frame: Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only

    Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter)

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 1, 2008
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.