#1 Clinical Trials Search in Europe

Indometacin Ph. Eur.

This article explores the use of Indometacin Ph. Eur. in clinical trials, specifically focusing on its role in the treatment of Langerhans Cell Histiocytosis (LCH) in children and adolescents. The LCH-IV trial, an international collaborative study, aims to improve treatment outcomes and reduce long-term complications for patients with this rare condition. We’ll discuss the trial’s objectives, eligibility criteria, and the potential benefits of using Indometacin as part of the treatment protocol.

Table of Contents

What is INDOMETACIN PH. EUR.?

INDOMETACIN PH. EUR. is an active substance used in medicine. It’s also known by its generic name, indomethacin. This drug is available in the form of hard capsules, specifically as INDOMETACIN CAPSULES BP 25mg[1]. Indometacin belongs to a class of medications called non-steroidal anti-inflammatory drugs (NSAIDs), which are known for their anti-inflammatory properties.

Medical Uses

Indometacin is primarily used as an anti-inflammatory medication[1]. It can help in treating various conditions characterized by pain, swelling, and inflammation. While the specific clinical trial data provided doesn’t detail all its uses, generally, indometacin is prescribed for:

  • Arthritis and joint pain
  • Muscle aches and pains
  • Headaches
  • Menstrual cramps

In the context of the clinical trial mentioned, indometacin is being studied as part of a treatment protocol for Langerhans Cell Histiocytosis (LCH), a rare disorder that can affect children and adolescents[1].

Dosage and Administration

According to the clinical trial information, the following dosage details are provided for INDOMETACIN PH. EUR.:

  • The maximum daily dose is 2 mg/kg (milligrams per kilogram of body weight)[1].
  • The maximum total dose amount is 1120 mg/kg[1].
  • The maximum treatment period is 80 weeks[1].

It’s important to note that this dosage information is specific to the clinical trial and may not reflect the typical dosage for other conditions. Always follow your doctor’s instructions regarding dosage and duration of treatment.

Role in Langerhans Cell Histiocytosis (LCH) Treatment

The clinical trial data suggests that INDOMETACIN PH. EUR. is being studied as part of a treatment protocol for Langerhans Cell Histiocytosis (LCH) in children and adolescents[1]. LCH is a rare disorder where certain immune system cells (called Langerhans cells) grow and multiply excessively, causing damage to various parts of the body.

In this trial, indometacin is being investigated as part of a continuation therapy. Specifically, it’s being compared to other medications (6-MP/MTX) for a 24-month continuation therapy in patients with non-risk organ involvement[1]. This is part of a broader study aiming to improve treatment outcomes for LCH patients.

Important Considerations

While INDOMETACIN PH. EUR. can be an effective medication, there are several important points to keep in mind:

  1. Prescription Only: This medication is only available with a doctor’s prescription. Never use it without proper medical supervision[1].
  2. Administration Route: INDOMETACIN PH. EUR. is taken orally in the form of capsules[1].
  3. Not for All Ages: The clinical trial data doesn’t indicate that this is a pediatric formulation, so its use in children should be carefully considered by healthcare professionals[1].
  4. Potential Side Effects: As with all medications, indometacin can cause side effects. Always discuss potential risks and benefits with your healthcare provider.
  5. Ongoing Research: The use of indometacin in LCH treatment is part of ongoing research. Its effectiveness and safety in this context are still being studied[1].

Remember, this information is based on clinical trial data and may not represent all uses or considerations for INDOMETACIN PH. EUR. Always consult with your healthcare provider for personalized medical advice and before starting or changing any medication regimen.

Aspect Details
Trial Name LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis
Trial Category Therapeutic exploratory and confirmatory clinical trial (Phase II and III integrated)
Medical Condition Langerhans Cell Histiocytosis
Main Objectives Reduce mortality in multi-system LCH, investigate continuation therapy options, reduce reactivation rates and late sequelae
Indometacin Ph. Eur. Role Used in continuation therapy, compared to 6-MP/MTX for 24 months total treatment
Dosage Maximum daily dose: 2 mg/kg, Maximum total dose: 1120 mg/kg
Administration Route Oral
Treatment Duration Up to 80 weeks
Primary Endpoints Reactivation-free survival, overall and disease-free survival, neurodegenerative CNS-LCH progression, response of CNS lesions, rate of permanent consequences
Key Eligibility Criteria Histologically verified LCH diagnosis, no prior systemic therapy, signed informed consent

FAQ

  • What is Langerhans Cell Histiocytosis (LCH)? Langerhans Cell Histiocytosis (LCH) is a rare condition that falls under the category of neoplasms, which are abnormal growths of cells. It primarily affects children and adolescents, causing the body to produce too many Langerhans cells, a type of white blood cell that helps fight infections.
  • What is the main goal of the LCH-IV trial? The main goal of the LCH-IV trial is to reduce mortality in multi-system LCH by switching patients with risk organ involvement to salvage treatment early if they don't respond to first-line therapy. The trial also aims to investigate ways to reduce reactivations and late complications through different treatment approaches.
  • How is Indometacin Ph. Eur. used in the LCH-IV trial? Indometacin Ph. Eur. is used as part of the continuation therapy in the LCH-IV trial. It's being compared to other medications (6-MP/MTX) for patients who have completed 24 weeks of second-line treatment with prednisolone, cytarabine, and vincristine.
  • What are the eligibility criteria for participating in the LCH-IV trial? To participate in the LCH-IV trial, patients must have a histologically verified diagnosis of LCH, no prior systemic therapy, signed informed consent, and meet the inclusion criteria for their respective treatment stratum. Patients with prior systemic therapy, missing consent forms, or LCH-related permanent consequences are excluded.
  • What are the potential benefits of participating in this clinical trial? Participating in the LCH-IV trial may help improve treatment outcomes for children and adolescents with LCH. The trial aims to reduce mortality, decrease reactivation rates, and minimize long-term complications. It also provides an opportunity to contribute to the advancement of medical knowledge about LCH and its treatment.

Ongoing Clinical Trials on Indometacin Ph. Eur.

  • Study on Langerhans Cell Histiocytosis Treatment in Children and Adolescents Using Cladribine, Prednisolone, and Cytarabine

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark Greece Ireland +6

Glossary

  • Langerhans Cell Histiocytosis (LCH): A rare condition where the body produces too many Langerhans cells, a type of white blood cell. It primarily affects children and adolescents and can cause various symptoms depending on which organs are involved.
  • Multi-system LCH (ms-LCH): A form of LCH where multiple organs or body systems are affected by the disease.
  • Single-system LCH (ss-LCH): A form of LCH where only one organ or body system is affected by the disease.
  • Risk organ: Organs that, when affected by LCH, can lead to more severe complications. These typically include the liver, spleen, and bone marrow.
  • Salvage treatment: A treatment used when the initial (first-line) therapy doesn't work or stops working. It's often more aggressive or uses different medications.
  • Reactivation: The return of disease activity after a period of improvement or remission.
  • Late sequelae: Long-term complications or effects that occur as a result of the disease or its treatment.
  • CNS-Risk lesion: Lesions in specific areas of the skull that are associated with a higher risk of central nervous system (brain) involvement in LCH.
  • Indometacin Ph. Eur.: A non-steroidal anti-inflammatory drug (NSAID) used in the LCH-IV trial as part of the continuation therapy.
  • Continuation therapy: A phase of treatment that follows the initial, more intensive treatment phase, aimed at maintaining remission and preventing disease recurrence.
  • Histological verification: Confirmation of a diagnosis by examining tissue samples under a microscope.
  • Systemic therapy: Treatment that affects the entire body, usually given orally or intravenously, as opposed to treatment that targets a specific area.
  • Reactivation-free survival: The length of time after treatment during which a patient remains free of disease reactivation.
  • Neurodegenerative CNS-LCH: A complication of LCH that affects the central nervous system, potentially leading to neurological problems.

References

  1. http://clinicaltrials.eu/trial/study-on-langerhans-cell-histiocytosis-treatment-in-children-and-adolescents-using-cladribine-prednisolone-and-cytarabine/