CLINICAL TRIALS PROFILE FOR BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

All Clinical Trials for BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND 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Trial Of Reduced- Dose Pylera, Amoxicillin, and Esomeprazole in the Treatment Of Helicobacter Pylori Infection	Withdrawn	American University of Beirut Medical Center	Phase 4	2013-06-01	Over the years, it has become clear that the first-line triple therapy is losing efficacy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 AND TETRACYCLINE HYDROCHLORIDE

Condition Name

Condition Name for BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND 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 AND TETRACYCLINE HYDROCHLORIDE
Intervention	Trials
Helicobacter Infections	2
Infections	1
Infection	1
Communicable Diseases	1

Clinical Trial Locations for BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

Trials by Country

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Trials by Country for BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
Location	Trials
United Kingdom	1
Lebanon	1
United States	1

Trials by US State

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Trials by US State for BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
Location	Trials
Texas	1

Clinical Trial Progress for BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1

Clinical Trial Status

Clinical Trial Status for BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Unknown status	1
Withdrawn	1
Completed	1

Clinical Trial Sponsors for BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND 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 AND TETRACYCLINE HYDROCHLORIDE
Sponsor	Trials
Industry	2
Other	2

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

Introduction

Bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride, commonly known by the brand name Pylera, is a combination medication used to treat peptic ulcers associated with Helicobacter pylori (H. pylori) infection. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Eradication of H. pylori

Clinical trials have demonstrated the efficacy of bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride in eradicating H. pylori infections. When used in combination with omeprazole, this regimen has shown significant success in treating patients with active duodenal ulcers or a history of duodenal ulcer disease within the past 5 years[2][3][4].

Dosage and Administration

The standard dosage involves administering three capsules four times a day (after meals and at bedtime) for 10 days, along with omeprazole 20 mg twice daily. This regimen has been shown to effectively reduce the risk of duodenal ulcer recurrence by eradicating H. pylori[2][3][5].

Safety Profile

While the drug is generally effective, it comes with several warnings and precautions. Metronidazole has been shown to be carcinogenic in animal studies, although its carcinogenic potential in humans is unknown. Tetracycline can cause fetal harm and is contraindicated during pregnancy. Other potential side effects include nausea, diarrhea, abdominal pain, and neurological symptoms[2][4][5].

Market Analysis

Market Presence

Pylera, the brand name for bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride, has been on the market since its initial U.S. approval in 2006. Recently, a generic version of Pylera was launched by Par Pharmaceutical, Inc., which is expected to increase market competition and potentially reduce costs for patients[4].

Market Demand

The demand for treatments targeting H. pylori infections remains high due to the prevalence of peptic ulcers and the importance of eradicating the bacteria to prevent recurrence. The global market for H. pylori eradication therapies is expected to grow, driven by increasing awareness and diagnosis of H. pylori infections, as well as the introduction of new and generic treatments.

Competitive Landscape

The market for H. pylori eradication therapies is competitive, with several other combination treatments available. However, Pylera and its generic counterparts hold a significant position due to their proven efficacy and established presence in the market. Other competitors include triple and quadruple therapy regimens that may include different antibiotics and acid suppressors[3][5].

Market Projections

Growth Potential

The market for bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride is projected to grow, driven by several factors:

• Increasing Prevalence of H. pylori Infections: As diagnostic techniques improve, more cases of H. pylori infections are being identified, leading to higher demand for effective treatments.
• Generic Competition: The introduction of generic versions of Pylera is expected to increase market penetration by making the treatment more affordable for a broader patient population.
• Advancements in Treatment Protocols: Continuous research and development in the field of gastroenterology may lead to improved treatment protocols, further solidifying the position of this combination therapy in the market[4].

Challenges and Opportunities

Despite the growth potential, there are several challenges to consider:

• Side Effects and Safety Concerns: The potential for serious side effects, such as carcinogenicity and fetal harm, necessitates careful patient selection and monitoring.
• Drug Resistance: The risk of developing drug-resistant bacteria is a concern that must be managed through responsible prescribing practices.
• Compliance: The complex dosing regimen may affect patient compliance, which can impact treatment efficacy[2][4][5].

Future Outlook

The future outlook for bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride is positive, with continued growth expected in the market for H. pylori eradication therapies. As generic versions become more widely available, access to this effective treatment will increase, benefiting a larger patient population.

Key Takeaways

• Efficacy: Bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride is highly effective in eradicating H. pylori infections when used in combination with omeprazole.
• Market Presence: The drug has a well-established presence in the market, with both brand and generic versions available.
• Growth Potential: The market is expected to grow due to increasing prevalence of H. pylori infections and the introduction of generic versions.
• Challenges: Side effects, safety concerns, drug resistance, and compliance issues need to be carefully managed.

FAQs

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

The primary indication is for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori[2][3][4].

How is the medication administered?

The medication is administered as three capsules four times a day (after meals and at bedtime) for 10 days, along with omeprazole 20 mg twice daily[2][3][5].

What are the common side effects of this medication?

Common side effects include nausea, diarrhea, upset stomach, abdominal pain, changes in taste, headache, dizziness, and vaginal itching or discharge[5].

Is the medication safe during pregnancy?

No, the medication is contraindicated during pregnancy due to the potential for fetal harm, particularly from the tetracycline component[4].

What are the potential long-term risks associated with this medication?

Long-term risks include the potential for carcinogenicity from metronidazole and tooth enamel discoloration from tetracycline, especially in children and during tooth development[2][4][5].

Sources

1. Cleveland Clinic: Bismuth Subcitrate Potassium; Metronidazole; Tetracycline Capsules.
2. Drugs.com: Bismuth, Metronidazole and Tetracycline Capsules.
3. Drugs.com: Bismuth subcitrate potassium/metronidazole/tetracycline.
4. PR Newswire: Endo Launches First Generic Version of Pylera.
5. RxList: Bismuth subcitrate potassium/Metronidazole/Tetracycline Hydrochloride.