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

NCT00669955 | Completed Phase 3 Results

• 1 other identifier: PYLHp07-01
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helicobacter Infections

Keywords

H. Pylori; Quadruple therapy; Eradication rate; Multinational trial; Resistance to antibiotics; Subjects with confirmed Helicobacter Pylori infection

Outcome Measures

Primary Outcomes (1)

• Helicobacter Pylori Eradication Confirmed by Urea Breath Test

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

  Week 6 and week 10 follow-up visits

Secondary Outcomes (6)

• Number of Patients Experiencing Treatment Emergent Adverse Events.

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

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

  Week 6 and week 10 follow-up visits

• Clarithromycin Resistance

  Measured at baseline

• Metronidazole Resistance

  Measured at baseline

• Overall Compliance to Study Medications

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

Study Arms (2)

OAC 7 days

ACTIVE COMPARATOR

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

Drug: Omeprazole, amoxicillin, clarithromycin

OBMT 10 days

EXPERIMENTAL

OBMT (Pylera), consisting of a 3 in 1 capsule, made of bismuth subcitrate potassium 120 mg, metronidazole 125 mg, and tetracycline 125 mg, administered as 3 capsules 4 times daily. Omeprazole 20 mg is administered twice daily.

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

Interventions

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

OAC 7 days

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.

Also known as: Pylera

OBMT 10 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (1)

Dr. I. Orpen

Bath, United Kingdom

Location

Related Publications (1)

• Malfertheiner P, Bazzoli F, Delchier JC, Celinski K, Giguere M, Riviere M, Megraud F; Pylera Study Group. Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial. Lancet. 2011 Mar 12;377(9769):905-13. doi: 10.1016/S0140-6736(11)60020-2. Epub 2011 Feb 21.

  PMID: 21345487 DERIVED

MeSH Terms

Conditions

Helicobacter Infections

Interventions

Omeprazole; Amoxicillin; Clarithromycin; Metronidazole; Tetracycline

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Monique Giguere, PhD, Programs Director,
• Organization: Axcan Pharma Inc.

1-800-565-3255

Study Officials

• Monique Giguère, PhD

  Axcan Pharma inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 16, 2017
• Results First Posted: August 5, 2010

Record last verified: 2017-02

Locations

GB (1)