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Nalbuphine Hydrochloride

Nalbuphine Hydrochloride, an opioid medication, is being studied in various clinical trials to assess its effectiveness in treating conditions like uremic pruritus, prurigo nodularis, and pain management in ICU patients. These trials aim to evaluate different formulations, dosages, and administration methods of Nalbuphine Hydrochloride to determine its safety, efficacy, and optimal use in different patient populations.

Table of Contents

What is Nalbuphine Hydrochloride?

Nalbuphine Hydrochloride, also known simply as nalbuphine, is a medication that belongs to a class of drugs called opioid agonist-antagonists[1]. This means it has properties that can both activate and block certain opioid receptors in the body, which are involved in pain perception and other functions. Nalbuphine is primarily used for pain management and has been studied for its potential in treating various conditions, particularly those involving severe itching (pruritus)[2].

Medical Conditions Treated with Nalbuphine

Nalbuphine Hydrochloride has been investigated for its effectiveness in treating several medical conditions, including:

  • Uremic Pruritus: This is a severe itching condition that affects patients with kidney failure who are undergoing hemodialysis. Nalbuphine has shown promise in reducing the intensity of itching in these patients[1].
  • Prurigo Nodularis: A chronic skin condition characterized by extremely itchy nodules on the skin. Clinical trials have explored the use of nalbuphine for relieving itching associated with this condition[2].
  • Pain Management: Nalbuphine is used for managing moderate to severe pain, particularly in perioperative settings (before, during, and after surgical procedures)[3].

Formulations and Administration

Nalbuphine Hydrochloride is available in several formulations:

  • Extended-Release (ER) Tablets: These are oral tablets designed to release the medication slowly over time, providing longer-lasting effects. They have been studied in various dosages, including 60 mg, 120 mg, 90 mg, and 180 mg, taken twice daily (BID)[4][5].
  • Injection: Nalbuphine is also available as an injectable solution, typically used in hospital settings for acute pain management or during surgical procedures[3].
  • Extended-Release Injection: A long-acting injectable form called NALDEBAIN ER Injection (also known as Dinalbuphine sebacate or Sebacoyl Dinalbuphine Ester Injection) has been studied for its extended pain relief properties[6].

Clinical Trials and Research

Numerous clinical trials have been conducted to evaluate the safety and efficacy of Nalbuphine Hydrochloride for various conditions:

  • Studies on uremic pruritus in hemodialysis patients have investigated different dosages of nalbuphine ER tablets, comparing them to placebo for itch relief[4].
  • Trials for prurigo nodularis have explored the anti-pruritic (anti-itching) effects of nalbuphine ER tablets at different doses[5].
  • Research has been conducted to understand how nalbuphine is processed by the body (pharmacokinetics) in patients with end-stage renal disease undergoing hemodialysis[7].
  • Comparative studies have been performed to evaluate nalbuphine against other pain medications like morphine for perioperative pain management[3].

Efficacy and Effectiveness

The effectiveness of Nalbuphine Hydrochloride has been measured in various ways across different studies:

  • Itch Relief: Many trials have used numerical rating scales or visual analog scales to measure changes in itch intensity. For example, a reduction in itch scores from baseline to the end of treatment periods has been a common measure of efficacy[4][5].
  • Pain Management: In pain studies, researchers have looked at factors such as pain intensity scores, the need for additional pain medication, and patient satisfaction with pain control[3].
  • Quality of Life: Some studies have incorporated quality of life assessments to understand how nalbuphine treatment affects patients’ overall well-being[3].

Safety and Side Effects

As with all medications, Nalbuphine Hydrochloride can cause side effects. Clinical trials have closely monitored the safety profile of nalbuphine:

  • Treatment-Emergent Adverse Events (TEAEs): These are undesirable effects that occur after starting the medication. Studies have tracked the number and percentage of patients experiencing TEAEs[1][2].
  • Common Side Effects: While specific side effects can vary, some commonly reported ones in opioid medications include nausea, vomiting, dizziness, and drowsiness. The exact profile for nalbuphine may differ and should be discussed with a healthcare provider[7].
  • Long-term Safety: Some studies have looked at the safety of nalbuphine over extended periods, up to 50 weeks in some cases, to understand its long-term effects[2].

Comparison with Other Medications

Research has been conducted to compare Nalbuphine Hydrochloride with other medications:

  • Morphine Comparison: A study compared nalbuphine to morphine for pain control during tumor ablation procedures. This research aimed to evaluate the analgesic efficacy, safety, and patient satisfaction between the two medications[3].
  • Placebo-Controlled Studies: Many trials have included placebo groups to determine the true effect of nalbuphine compared to no active treatment[4][5].

It’s important to note that the choice of medication depends on individual patient factors, the specific condition being treated, and the judgment of the healthcare provider. Patients should always consult with their doctor about the most appropriate treatment options for their situation.

Aspect Details
Main Conditions Studied Uremic Pruritus, Prurigo Nodularis, Pain in ICU patients
Formulations Extended-release tablets, Injections, NALDEBAIN ER Injection
Dosage Ranges Tablets: 30mg to 240mg BID; Injections: varies by study
Primary Outcomes Change in itch intensity, Analgesic success rate, Pharmacokinetics
Safety Monitoring Treatment-emergent adverse events, Tolerability
Study Durations 8-10 weeks for main studies; up to 50 weeks for extension studies
Special Populations Hemodialysis patients, ICU patients with respiratory insufficiency
Comparison Treatments Placebo, Hydromorphone hydrochloride

FAQ

  • What conditions are being studied with Nalbuphine Hydrochloride in clinical trials? Clinical trials are investigating Nalbuphine Hydrochloride for treating uremic pruritus in hemodialysis patients, prurigo nodularis, and pain management in ICU patients with respiratory insufficiency.
  • What are the different formulations of Nalbuphine Hydrochloride being tested? Various formulations are being studied, including extended-release (ER) tablets, injections, and a long-acting formulation called NALDEBAIN ER Injection (Dinalbuphine sebacate).
  • How is the effectiveness of Nalbuphine Hydrochloride measured in these trials? Effectiveness is measured using scales like the Numerical Rating Scale (NRS) for itch intensity, Visual Analogue Scale (VAS) for anti-pruritic effects, and the Critical-Care Pain Observation Tool (CPOT) for pain assessment in ICU patients.
  • What are some of the side effects being monitored in these trials? The trials are monitoring for treatment-emergent adverse events (TEAEs), with a focus on common opioid-related side effects such as nausea and vomiting. The overall safety and tolerability of the drug are key aspects of the studies.
  • How long do these clinical trials typically last? The duration of the trials varies. Some studies last for 8-10 weeks, while others, particularly the extension studies, can last up to 24 or even 50 weeks to assess long-term safety and efficacy.

Ongoing Clinical Trials on Nalbuphine Hydrochloride

  • Study on Preventing Persistent Postoperative Pain in Children Using Mepivacaine Hydrochloride and Drug Combination

    Recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study on Nalbuphine ER for Treating Cough in Patients with Idiopathic Pulmonary Fibrosis

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy The Netherlands Poland Spain

Glossary

  • Uremic Pruritus: A common and distressing symptom in patients with kidney failure, characterized by severe itching of the skin.
  • Prurigo Nodularis: A skin condition characterized by hard, itchy lumps (nodules) that develop on the skin as a result of chronic scratching or picking.
  • Extended Release (ER): A formulation of a drug designed to release the active ingredient slowly over time, allowing for less frequent dosing.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Numerical Rating Scale (NRS): A scale used to measure the intensity of symptoms, such as itch or pain, typically ranging from 0 to 10.
  • Treatment-Emergent Adverse Events (TEAEs): Side effects or undesirable experiences that occur after starting a treatment in a clinical trial.
  • Hemodialysis: A medical procedure to filter waste products from the blood when the kidneys are not working properly.
  • Bioavailability: The proportion of a drug that enters the circulation when introduced into the body and is able to have an active effect.
  • Critical-Care Pain Observation Tool (CPOT): A scale used to assess pain in critically ill patients who may not be able to communicate verbally.
  • Richmond Agitation-Sedation Scale (RASS): A scale used to measure the agitation or sedation level of patients in intensive care settings.

References

  1. https://clinicaltrials.gov/study/NCT02143973
  2. https://clinicaltrials.gov/study/NCT02174432
  3. https://clinicaltrials.gov/study/NCT05073744
  4. https://clinicaltrials.gov/study/NCT02143648
  5. https://clinicaltrials.gov/study/NCT02174419
  6. https://clinicaltrials.gov/study/NCT04256434
  7. https://clinicaltrials.gov/study/NCT02373215