CLINICAL TRIALS PROFILE FOR BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

All Clinical Trials for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02045251 ↗	An Open-Label Trial Of Reduced- Dose Pylera, Amoxicillin, and Esomeprazole in the Treatment Of Helicobacter Pylori Infection	Withdrawn	American University of Beirut Medical Center	Phase 4	2013-06-01	Over the years, it has become clear that the first-line triple therapy is losing efficacy worldwide. A capsule containing 3 agents (Pylera®) containing 125mg metronidazole, 140mg bismuth subcitrate potassium, and 125mg tetracycline was made available. The efficacy of the Pylera capsule was studied in a randomized control trial, in which a quadruple Pylera therapy (Pylera capsule and a PPI) was evaluated against the standard triple regimen. In the study, 3 three-in-one capsules were taken four times daily (after meals and at bedtime). Given the above, we aim at assessing the effectiveness of fewer pills per day of the Pylera capsule (3 Pylera capsules supplemented with the addition of amoxicillin and esomeprazole twice daily; sum of 10 pills/day for 10 days) in the eradication of H. pylori.
NCT01335334 ↗	H. Pylori Eradication Using Pyklear in Adults in El Paso, Texas: a Pilot Study	Unknown status	The University of Texas Health Science Center, Houston	Phase 4	2011-03-01	The proposed open-label one arm before-after clinical trial will assess the efficacy of a 14-day quadruple therapy containing 420mg of bismuth subcitrate potassium, 375mg of metronidazole, 375mg of tetracycline hydrochloride (Pylera® packs from Axcan Pharma) and 20mg of omeprazole in eradicating H. pylori infection in 50 asymptomatic adults in El Paso, Texas. As part of the study we will obtain specimens for culture of H. pylori in a reference laboratory.
NCT00669955 ↗	Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy	Completed	Axcan Pharma	Phase 3	2008-06-01	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.
NCT00669955 ↗	Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy	Completed	Forest Laboratories	Phase 3	2008-06-01	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.

Clinical Trial Conditions for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

Condition Name

Condition Name for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride
Intervention	Trials
Treatment of H. Pylori Infection	1
H. Pylori Infection	1
Helicobacter Infections	1

Condition MeSH

Condition MeSH for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride
Intervention	Trials
Helicobacter Infections	2
Infections	1
Infection	1
Communicable Diseases	1

Clinical Trial Locations for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

Trials by Country

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Trials by Country for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride
Location	Trials
Lebanon	1
United States	1
United Kingdom	1

Trials by US State

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−

Trials by US State for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride
Location	Trials
Texas	1

Clinical Trial Progress for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

Clinical Trial Phase

Clinical Trial Phase for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1

Clinical Trial Status

Clinical Trial Status for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride
Clinical Trial Phase	Trials
Unknown status	1
Withdrawn	1
Completed	1

Clinical Trial Sponsors for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride

Sponsor Name

Sponsor Name for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride
Sponsor	Trials
Axcan Pharma	1
Forest Laboratories	1
The University of Texas Health Science Center, Houston	1

Sponsor Type

Sponsor Type for bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride
Sponsor	Trials
Industry	2
Other	2

Bismuth Subcitrate Potassium, Metronidazole, Tetracycline Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Helicobacter pylori (H. pylori) infection is a widespread condition that can lead to duodenal ulcer disease and other gastrointestinal issues. The combination of bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride, often used in conjunction with omeprazole, has emerged as a potent treatment for H. pylori eradication. Here, we will delve into the clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Overview

Efficacy and Safety

Clinical trials have consistently shown the efficacy and safety of the quadruple therapy regimen consisting of bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride, and omeprazole. A multicenter, open-label study demonstrated high H. pylori eradication rates, ranging from 93.2% to 93.8% in the intent-to-treat population and from 94.7% to 95.0% in the per-protocol population[1].

Patient Population

These trials typically involve patients who have failed previous standard triple therapy regimens, such as omeprazole, amoxicillin, and clarithromycin (OAC). The inclusion of patients with metronidazole and clarithromycin resistance highlights the regimen's effectiveness even in challenging cases[1].

Adverse Events

While the treatment is generally well-tolerated, adverse events have been reported. Common side effects include gastrointestinal symptoms, and in some cases, more severe reactions such as hypersensitivity and renal impairment have been noted. However, the overall discontinuation rate due to adverse events is low, indicating the regimen's safety profile[1][2].

Market Analysis

Market Presence

The brand name Pylera, which combines bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride, has been a significant player in the market. Recently, Endo launched the first generic version of Pylera, which is expected to increase accessibility and reduce costs for patients[2].

Sales and Revenue

As of 2022, Pylera sales were approximately $30 million for the 12 months ended December 31. The introduction of a generic version is likely to impact these figures, potentially increasing market share due to the lower cost[2].

Pricing

The cost of the generic version of bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride capsules is around $277 for a supply of 120 capsules, making it a more affordable option for patients compared to the brand name[5].

Indications and Usage

Helicobacter pylori Eradication

The primary indication for this drug combination is the eradication of H. pylori infection, particularly in patients with active or a history of duodenal ulcer disease within the past five years. The eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence[2][4].

Dosage and Administration

The typical dosage involves taking three capsules four times daily (q.d.s.) of the combination formulation, along with omeprazole 20 mg twice daily (b.d.) for 10 days[1].

Contraindications and Warnings

Pregnancy and Lactation

The use of this drug combination is contraindicated during pregnancy due to the potential for fetal harm, particularly from tetracycline, which can cause permanent tooth discoloration and inhibit bone development[2].

Renal Impairment

The treatment is contraindicated in patients with severe renal impairment due to the risk of increased blood urea nitrogen (BUN) and other renal complications[2].

Hypersensitivity Reactions

Patients with known hypersensitivity to bismuth subcitrate potassium, metronidazole, or tetracycline should avoid this treatment due to the risk of severe reactions[2].

Future Projections

Market Growth

The introduction of generic versions is expected to drive market growth by increasing accessibility and reducing costs. This could lead to a higher adoption rate among healthcare providers and patients, especially in regions where cost is a significant factor[2].

Competitive Landscape

The entry of generic competitors will likely lead to a more competitive market, potentially driving down prices further and increasing the overall market size. This competition could also spur innovation in formulation and delivery methods[2].

Regulatory Environment

Regulatory approvals and guidelines will continue to play a crucial role in the market dynamics. Any changes in regulatory policies or the approval of new indications could significantly impact the market[2].

Key Takeaways

• High Efficacy: The quadruple therapy regimen of bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride, and omeprazole has shown high H. pylori eradication rates.
• Market Expansion: The launch of generic versions is expected to increase market accessibility and reduce costs.
• Safety Profile: While generally well-tolerated, the treatment has specific contraindications and warnings, particularly regarding pregnancy and renal impairment.
• Future Growth: The market is projected to grow due to increased competition and lower costs, potentially leading to higher adoption rates.

FAQs

What is the primary indication for bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride?

The primary indication is the eradication of Helicobacter pylori infection, particularly in patients with active or a history of duodenal ulcer disease within the past five years[2].

How effective is the quadruple therapy regimen in eradicating H. pylori?

Clinical trials have shown eradication rates ranging from 93.2% to 95.0% in different patient populations[1].

What are the common side effects of this treatment?

Common side effects include gastrointestinal symptoms, and in some cases, more severe reactions such as hypersensitivity and renal impairment have been noted[1][2].

Is this treatment contraindicated in any specific patient groups?

Yes, it is contraindicated in patients with severe renal impairment, during pregnancy, and in those with known hypersensitivity to the components[2].

How does the introduction of generic versions impact the market?

The introduction of generic versions is expected to increase market accessibility, reduce costs, and drive market growth by increasing adoption rates[2].

Sources

1. PubMed: Use of a combination formulation of bismuth, metronidazole and tetracycline hydrochloride with omeprazole in the eradication of Helicobacter pylori in patients who have failed previous eradication therapy.
2. PR Newswire: Endo Launches First Generic Version of Pylera® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) Capsules.
3. Clinical Trials Register: Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given x 10 days With Omeprazole.
4. Health Canada: Product Monograph - Pylera® Bismuth Subcitrate Potassium, Metronidazole, Tetracycline Hydrochloride Capsules.
5. Drugs.com: Bismuth subcitrate potassium / metronidazole / tetracycline Prices, Coupons, Copay Cards & Patient Assistance.