CLINICAL TRIALS PROFILE FOR TAGAMET HB

All Clinical Trials for Tagamet Hb

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01256879 ↗	Cimetidine Biowaivers	Completed	Food and Drug Administration (FDA)	Phase 4	2011-03-01	The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.
NCT01256879 ↗	Cimetidine Biowaivers	Completed	University of Maryland	Phase 4	2011-03-01	The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.
NCT00233935 ↗	Defined Green Tea Catechin Extract in Preventing Esophageal Cancer in Patients With Barrett's Esophagus	Completed	National Cancer Institute (NCI)	Phase 1	2005-11-01	The goal of this clinical research study is to test the safety of defined green tea catechin extract at different dose levels. Researchers also want to find out what effects, good and bad, it may have on individual and their risk for esophagus cancer. Esophagus cancer is an increased risk associated with Barrett's esophagus. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of defined green tea catechin extract may prevent esophageal cancer.
NCT00038402 ↗	Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer	Completed	Genentech, Inc.	Phase 3	2001-04-01	The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.
NCT00038402 ↗	Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer	Completed	M.D. Anderson Cancer Center	Phase 3	2001-04-01	The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.

Clinical Trial Conditions for Tagamet Hb

Condition Name

Condition Name for Tagamet Hb
Intervention	Trials
Anatomic Stage IV Breast Cancer AJCC v8	1
Prognostic Stage IB Breast Cancer AJCC v8	1
Anatomic Stage I Breast Cancer AJCC v8	1
Barrett Esophagus	1

Condition MeSH

Condition MeSH for Tagamet Hb
Intervention	Trials
Breast Neoplasms	2
Ulcer	1
Barrett Esophagus	1
Breast Carcinoma In Situ	1

Clinical Trial Locations for Tagamet Hb

Trials by Country

+

−

Trials by Country for Tagamet Hb
Location	Trials
United States	7
China	1

Trials by US State

+

−

Trials by US State for Tagamet Hb
Location	Trials
Washington	2
Texas	2
Ohio	1
Maryland	1
New York	1

Clinical Trial Progress for Tagamet Hb

Clinical Trial Phase

Clinical Trial Phase for Tagamet Hb
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Tagamet Hb
Clinical Trial Phase	Trials
Completed	4
Recruiting	3

Clinical Trial Sponsors for Tagamet Hb

Sponsor Name

Sponsor Name for Tagamet Hb
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2
Ohio State University Comprehensive Cancer Center	1
National Institutes of Health (NIH)	1

Sponsor Type

Sponsor Type for Tagamet Hb
Sponsor	Trials
Other	6
NIH	4
Industry	2

Tagamet HB: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Tagamet HB

Tagamet HB, known generically as cimetidine, is a histamine H2-receptor antagonist used primarily for the prevention and relief of heartburn, acid indigestion, and sour stomach. Introduced by SmithKline Beecham in 1977, it was the first drug to achieve blockbuster status, exceeding $1 billion in sales in a single year by 1986[2][5].

Clinical Trials and Efficacy

Early Clinical Trials

The initial clinical trials for cimetidine, conducted in the late 1970s and early 1980s, focused on its efficacy in treating duodenal ulcers. These phase II/III trials in the U.S. demonstrated that cimetidine was significantly more effective than placebo in reducing the time lost from work due to ulcer disease. The trials highlighted the drug's ability to alleviate symptoms and improve the quality of life for patients with duodenal ulcers[3].

OTC Transition and Subsequent Trials

When the patent for Tagamet expired in 1994, SmithKline Beecham sought FDA approval for an over-the-counter (OTC) version, Tagamet HB. Clinical trials for the OTC formulation were conducted to ensure its safety and efficacy for self-medication. These trials were crucial in establishing the appropriate dosage and administration guidelines for the OTC market[5].

Dosage and Administration

Adult Dosage

For adults, Tagamet HB is recommended at a dose of 200mg taken within 30 minutes before eating or drinking to prevent heartburn, acid indigestion, and sour stomach. For relief, the same dose can be taken once daily as needed, with a maximum daily dose of 400mg[1][4].

Children and Special Populations

Tagamet HB is not recommended for children. For patients with renal or hepatic impairment, caution is advised, and the medication should be used under the guidance of a healthcare provider. Pregnant and nursing mothers should also consult their doctors before using this medication[1][4].

Market Analysis

Historical Context

Tagamet was a groundbreaking drug that pioneered the H2 blocker market. It earned SmithKline Beecham a total of $14 billion worldwide and was the first drug to achieve $1 billion in sales in a single year. However, with the expiration of its patent in 1994, the market dynamics changed significantly[5].

Competition and Market Share

The OTC market saw intense competition with the introduction of other H2 blockers like Pepcid AC by Johnson & Johnson/Merck. Pepcid AC gained a 22% share of the entire antacid market shortly after its introduction, exploiting the window of opportunity before Tagamet HB was approved for OTC sale. Despite this, Tagamet HB remained a strong contender, with both companies investing heavily in marketing campaigns[5].

Pricing and Consumer Behavior

The pricing of Tagamet HB and other OTC H2 blockers was significantly higher than traditional antacids like Tums. However, consumers were willing to pay the premium for the perceived effectiveness and convenience of these products. This trend indicated that heartburn sufferers were not deterred by the higher cost, especially with the availability of rebates and promotions[5].

Market Projections

Future Market Trends

The market for heartburn medications continues to grow, driven by increasing awareness and the prevalence of gastrointestinal disorders. The introduction of OTC versions of H2 blockers has expanded the market, making these medications more accessible to a broader audience.

Competitive Landscape

The competitive landscape is expected to remain dynamic, with existing players like SmithKline Beecham and Johnson & Johnson/Merck continuing to innovate and market their products aggressively. New entrants and generic versions will also play a significant role in shaping the market.

Economic Impact

The economic impact of Tagamet HB and similar medications is substantial. The shift to OTC sales has opened up new revenue streams for pharmaceutical companies, despite the cannibalization of traditional antacid products. The market is projected to continue growing, with an additional $1 billion in sales anticipated for heartburn medications[5].

Interactions and Side Effects

Drug Interactions

Tagamet HB can interact with several medications by inhibiting hepatic microsomal enzymes, which may potentiate the effects of anticoagulants, phenytoin, theophylline, lidocaine, triazolam, and others. Patients should consult their healthcare providers to manage these interactions effectively[1][4].

Side Effects

Common side effects of Tagamet HB include headache, dizziness, drowsiness, and diarrhea. Serious side effects, though rare, can include mental/mood changes, trouble urinating, muscle/joint pain, and signs of liver or kidney problems. Patients should report any persistent or worsening side effects to their healthcare providers promptly[4].

Patient Counseling and Warnings

Patient Counseling

Patients should be advised to take Tagamet HB as directed, separating it from antacids by at least one hour. They should also be informed about potential interactions with other medications and the importance of reporting any serious side effects[4].

Warnings and Precautions

Patients with symptoms persisting or worsening after 14 days should reevaluate their treatment. Those with renal or hepatic impairment, pregnancy, or nursing should use the medication under medical supervision. Symptoms such as chest or shoulder pain, shortness of breath, or lightheadedness should be reported immediately[1].

Key Takeaways

• Clinical Efficacy: Tagamet HB has been proven effective in clinical trials for treating duodenal ulcers and heartburn.
• Market Impact: It was the first blockbuster drug and continues to influence the market for heartburn medications.
• Dosage and Administration: The medication is taken at a dose of 200mg before eating or as needed, with a maximum daily dose of 400mg.
• Market Competition: The OTC market is highly competitive, with Tagamet HB competing against other H2 blockers like Pepcid AC.
• Economic Projections: The market for heartburn medications is expected to grow, with significant economic impact.

FAQs

What is Tagamet HB used for?

Tagamet HB is used for the prevention and relief of heartburn, acid indigestion, and sour stomach.

How should Tagamet HB be taken?

It should be taken 200mg within 30 minutes before eating or drinking to prevent symptoms, or once daily as needed for relief, with a maximum daily dose of 400mg.

Can children use Tagamet HB?

No, Tagamet HB is not recommended for children.

What are the potential side effects of Tagamet HB?

Common side effects include headache, dizziness, drowsiness, and diarrhea. Serious side effects can include mental/mood changes, trouble urinating, and signs of liver or kidney problems.

Does Tagamet HB interact with other medications?

Yes, it can interact with several medications by inhibiting hepatic microsomal enzymes, and patients should consult their healthcare providers to manage these interactions.

Sources

1. TAGAMET HB Prescription & Dosage Information - eMPR.com
2. Beginning of an Era The First Blockbuster Drug, Tagamet - Oxford University Press
3. The effect of cimetidine on days of work lost in a short-term trial in ... - PubMed
4. Tagamet HB Oral: Uses, Side Effects, Interactions, Pictures ... - WebMD
5. FIRE IN THE BELLY, MONEY IN THE BANK - Time Magazine