#1 Clinical Trials Search in Europe

Cimetidine

This article summarizes several clinical trials investigating the use of cimetidine, a histamine H2-receptor antagonist, in different medical contexts. These studies explore cimetidine’s potential effects on bioequivalence, protoporphyrias, HIV infection, drug interactions, stress ulcer prophylaxis, atopic dermatitis, and kidney transplantation. The trials aim to evaluate cimetidine’s efficacy, safety, and pharmacokinetic properties in various patient populations.

Table of Contents

What is Cimetidine?

Cimetidine is a medication that belongs to a class of drugs called H2 receptor antagonists, also known as H2 blockers. It is commonly sold under the brand name Tagamet[1][2]. Cimetidine has been widely used for many years, primarily to treat conditions related to excess stomach acid[1].

Uses of Cimetidine

Cimetidine is used to treat various conditions, including:

  • Stress Ulcer Prophylaxis: It helps prevent stress-related upper gastrointestinal (GI) bleeding in seriously ill patients[3].
  • Gastroesophageal Reflux Disease (GERD): Cimetidine can help reduce stomach acid, alleviating symptoms of GERD[1].
  • Peptic Ulcers: It aids in the treatment and prevention of stomach and duodenal ulcers[1].
  • Atopic Dermatitis: Some studies have explored its potential in treating acute extrinsic atopic dermatitis, a type of eczema[4].

How Cimetidine Works

Cimetidine works by blocking histamine receptors in the stomach. Specifically, it targets H2 receptors, which are responsible for stimulating acid production. By blocking these receptors, cimetidine reduces the amount of acid produced by the stomach[1].

In addition to its effects on stomach acid, cimetidine has been found to have some immunomodulatory properties. This means it can affect the immune system. In the context of atopic dermatitis, it may help by:

  • Activating Th1 cells (a type of immune cell)
  • Lowering Th2 cell activity
  • Reducing levels of Immunoglobulin E (IgE), an antibody associated with allergic reactions[4]

Cimetidine in Clinical Trials

Cimetidine has been the subject of numerous clinical trials exploring its various uses and effects:

  • Stress Ulcer Prevention: A study compared intravenous cimetidine to esomeprazole for preventing stress-related upper GI bleeding in seriously ill patients[3].
  • Atopic Dermatitis: Research has investigated cimetidine’s potential in treating acute extrinsic atopic dermatitis, measuring its effects on various immune markers and disease severity[4].
  • HIV Treatment: A study explored cimetidine’s effect on CD4 lymphocyte counts in HIV-infected patients[5].
  • Drug Interactions: Several trials have examined how cimetidine interacts with other medications, such as imeglimin and lucerastat[6][7].
  • Renal Function: Research has looked at how cimetidine affects the accuracy of tests measuring kidney function in transplant patients[8].

Side Effects and Safety

While cimetidine is generally considered safe, like all medications, it can cause side effects. Common side effects may include:

  • Headache
  • Dizziness
  • Diarrhea or constipation
  • Muscle pain
  • Rash[1]

It’s important to note that the safety and side effect profile can vary depending on the dosage, route of administration (oral or intravenous), and individual patient factors[3].

Special Considerations

There are several special considerations to keep in mind when using cimetidine:

  • Drug Interactions: Cimetidine can interact with various medications. It may affect how other drugs are processed in the body, potentially increasing or decreasing their effectiveness[6][7].
  • Kidney Function: Cimetidine can affect certain tests used to measure kidney function. This is important for doctors to consider when interpreting test results, especially in kidney transplant patients[8].
  • Breastfeeding: Cimetidine can be excreted in breast milk. Studies are ongoing to better understand how this might affect infants and how the excretion changes over time postpartum[9].

Always consult with your healthcare provider before starting or stopping any medication, including cimetidine. They can provide personalized advice based on your specific health situation and any other medications you may be taking.

Study Focus Key Findings/Objectives
Bioequivalence Investigating the effects of excipients on cimetidine absorption in capsules and oral solutions
Protoporphyrias Evaluating cimetidine’s efficacy in reducing protoporphyrin levels and improving photosensitivity
HIV Infection Assessing cimetidine’s impact on CD4 lymphocyte counts in HIV-infected patients
Drug Interactions Studying cimetidine’s effects on the pharmacokinetics of other medications (e.g., imeglimin, lucerastat)
Stress Ulcer Prophylaxis Comparing intravenous esomeprazole to cimetidine for preventing upper GI bleeding in seriously ill patients
Atopic Dermatitis Investigating cimetidine’s efficacy in reducing atopic dermatitis severity and modulating immune responses
Kidney Transplantation Evaluating the performance of cimetidine-corrected MDRD equation in estimating GFR in renal transplant patients

FAQ

  • What is cimetidine? Cimetidine is a histamine H2-receptor antagonist medication that decreases stomach acid production. It is commonly used to treat gastrointestinal conditions but is being studied for potential effects in other medical areas.
  • What conditions are being studied with cimetidine in these clinical trials? The clinical trials are investigating cimetidine's use in bioequivalence studies, protoporphyrias, HIV infection, drug interactions, stress ulcer prophylaxis, atopic dermatitis, and kidney transplantation.
  • How is cimetidine being used in protoporphyria studies? In protoporphyria studies, cimetidine is being evaluated for its potential to reduce protoporphyrin levels, improve photosensitivity, and enhance quality of life in patients with erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP).
  • What is the purpose of using cimetidine in drug interaction studies? Cimetidine is used in drug interaction studies to assess its effects on the pharmacokinetics of other medications. These studies help determine if cimetidine alters the absorption, distribution, metabolism, or excretion of other drugs when taken together.
  • How is cimetidine being evaluated in atopic dermatitis treatment? In atopic dermatitis studies, cimetidine is being investigated for its potential to modulate the immune system by activating Th1 and lowering Th2 activity, as well as reducing IgE levels, which may help reduce the severity of atopic dermatitis symptoms.

Ongoing Clinical Trials on Cimetidine

  • Study of drug combination therapy in asymptomatic patients with frequent premature ventricular contractions and normal heart function to prevent left ventricular dysfunction

    Recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Study of LTX-315 and Pembrolizumab for Patients with Advanced Melanoma Resistant to PD-1/PD-L1 Therapy

    Not recruiting

    1 1 1
    Investigated drugs:
    France Norway Spain

Glossary

  • Bioequivalence: The property of two drug products having the same biological effect and rate of absorption when administered in the same dose under similar conditions.
  • Protoporphyria: A group of genetic disorders affecting heme biosynthesis, resulting in accumulation of light-sensitive molecules that cause painful cutaneous sensitivity to light.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and excreted by the body over time.
  • CD4 count: A measure of the number of CD4 T lymphocytes in the blood, used to assess the immune system's health in HIV-infected individuals.
  • Stress ulcer prophylaxis: Preventive treatment to reduce the risk of stress-related gastrointestinal bleeding in seriously ill patients.
  • Atopic dermatitis: A chronic inflammatory skin condition characterized by itchy, red, and swollen skin.
  • Immunoglobulin E (IgE): An antibody that plays a crucial role in allergic responses and is often elevated in individuals with atopic conditions.
  • SCORAD: Scoring Atopic Dermatitis, a tool used to measure the severity of atopic dermatitis symptoms.
  • Glomerular Filtration Rate (GFR): A measure of kidney function that estimates how much blood passes through the glomeruli each minute.
  • MDRD equation: Modification of Diet in Renal Disease equation, used to estimate glomerular filtration rate based on serum creatinine levels.

References

  1. https://clinicaltrials.gov/study/NCT01256879
  2. https://clinicaltrials.gov/study/NCT05020184
  3. https://clinicaltrials.gov/study/NCT02157376
  4. https://clinicaltrials.gov/study/NCT04018131
  5. https://clinicaltrials.gov/study/NCT00002092
  6. https://clinicaltrials.gov/study/NCT03618316
  7. https://clinicaltrials.gov/study/NCT03380455
  8. https://clinicaltrials.gov/study/NCT00475059
  9. https://clinicaltrials.gov/study/NCT06056583