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Amitriptyline

Clinical trials of Amitriptyline are studying how it performs in different pain conditions, especially neuropathic pain and chronic back pain. These studies look at pain relief, tolerability, and how it compares with other treatments or placebo in adults with ongoing pain.

Table of Contents

Trial overview

The provided trials investigate Amitriptyline in studies of pain, mainly neuropathic pain, which means pain caused by nerve problems.[1][2] These studies are not about the drug as a general medicine; they focus on how it is used in research for specific pain conditions.[1][2]

All five trials in the source data are marked Completed.[1][2][3][4][5] They include one Phase 2 study and four Phase 3 studies.[1][2][3][4][5]

Conditions studied

The trials cover several long-lasting pain conditions.[1][2][3][4][5] One study looks at people with head and neck cancer in remission who still have neuropathic pain.[1]

Other studies focus on chronic pain due to traumatic or post-operative peripheral neuropathy, chronic back pain, diabetic polyneuropathy, and central neuropathy of any genesis.[2][3][4][5] “Any genesis” means the cause can be any origin, not just one single cause.[5]

Study designs and phases

All trials are interventional, which means the researchers give a treatment and then measure what happens.[1][2][3][4][5] The Phase 2 study has 130 planned participants, while each Phase 3 study has 558 planned participants.[1][2][3][4][5]

Phase 2 studies usually explore whether a treatment may help and continue safety checks.[1] Phase 3 studies are larger and are used to compare treatments more clearly.[2][3][4][5]

Main outcomes measured

The main outcome in most trials is pain change, measured with the Numeric Rating Scale (NRS), a 0 to 10 pain score where higher numbers mean more pain.[2][3][4][5] These studies compare pain at the start of the trial with pain after treatment, including week 14 in the Phase 3 studies.[2][3][4][5]

In the Phase 2 head and neck cancer study, the main outcome is the rate of patients whose average pain over the last 24 hours drops by 2 points at 9 months compared with entry into the study.[1] This is a way to measure a meaningful improvement in pain for the patient.[1]

Who participated

The target populations are adults with chronic pain related to nerve injury or nerve disease, and one group with cancer-related neuropathic pain after remission.[1][2][3][4][5] The trial data do not provide full entry rules, so the exact inclusion and exclusion criteria are not shown here.[1][2][3][4][5]

What the trials compare

Several studies compare Amitriptyline-related treatment approaches with placebo, which is a look-alike treatment without active medicine.[2][3][4][5] The head and neck cancer study compares a capsaicin patch strategy with a reference neuropathic treatment using Amitriptyline.[1]

The Phase 3 studies also list other pain treatments in their intervention sets, showing that the research is part of broader comparisons for chronic pain management.[2][3][4][5] The source data name AP707 in several trials, which is the study treatment being evaluated in those trials.[2][3][4][5]

Trial IDPhaseCondition studiedStatusEnrollment
NCT04704453Phase 2Head and neck cancer with remission and neuropathic painCompleted130
2022-500898-13-00Phase 3Chronic pain due to traumatic or post-operative peripheral neuropathyCompleted558
2022-502151-54-00Phase 3Chronic back painCompleted558
2022-500897-32-00Phase 3Chronic pain due to diabetic polyneuropathyCompleted558
2022-500899-66-00Phase 3Chronic pain due to central neuropathy of any genesisCompleted558

FAQ

  • What are the clinical trials of Amitriptyline studying? The trials are studying Amitriptyline as a treatment for pain, especially neuropathic pain and chronic back pain. They measure whether pain improves and how well patients tolerate treatment.
  • Who can take part in these trials? The target groups are adults with chronic pain conditions such as diabetic polyneuropathy, central neuropathy, traumatic or post-operative peripheral neuropathy, chronic back pain, and head and neck cancer in remission with neuropathic pain. Each study has its own entry rules.
  • What phases are the Amitriptyline trials in? The trials listed are Phase 2 and Phase 3 studies. Phase 2 and Phase 3 usually test whether a treatment works and how well it is tolerated in larger groups of patients.
  • What do the trials measure? The main measures are changes in pain scores, such as the Numeric Rating Scale or average pain over the last 24 hours. One study also looks at the number of patients who have at least a 2-point drop in pain.
  • Are these studies completed? Yes. All of the trials listed are marked as completed. This means the study treatment and follow-up have already finished.

Ongoing Clinical Trials on Amitriptyline

  • Study on Capsaicin Patch and Amitriptyline for Neuropathic Pain in Head and Neck Cancer Patients in Remission

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Effectiveness and Safety of AP707 and Naproxen for Patients with Chronic Back Pain

    Not recruiting

    3 1 1
    Investigated drugs:
    Austria Germany

  • Study on the Effectiveness of AP707, Gabapentin, and Capsaicin for Patients with Chronic Pain from Traumatic or Post-Operative Peripheral Neuropathy

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

  • Study on the Effectiveness and Safety of AP707 with Lamotrigine and Amitriptyline for Patients with Chronic Central Neuropathic Pain

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

  • Study on the Effectiveness and Safety of AP707, Amitriptyline, and Capsaicin for Patients with Chronic Pain from Diabetic Neuropathy

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany

Glossary

  • Clinical trial: A research study in people that tests whether a treatment works and how safe or useful it is.
  • Interventional study: A study where researchers give a treatment or compare treatments to see what happens.
  • Phase 2: A mid-stage trial that checks whether a treatment may work and continues safety review.
  • Phase 3: A later-stage trial with more people, often used to compare a treatment with another treatment or placebo.
  • Neuropathic pain: Pain caused by nerve damage or nerve problems.
  • Peripheral neuropathy: A condition where nerves outside the brain and spinal cord are damaged.
  • Diabetic polyneuropathy: Nerve damage linked to diabetes that can cause pain, numbness, or tingling.
  • Central neuropathy: Nerve pain related to the central nervous system, which includes the brain and spinal cord.
  • Numeric Rating Scale (NRS): A pain scale from 0 to 10, where 0 means no pain and 10 means the worst pain.
  • Placebo: A treatment that looks like the real study treatment but has no active medicine.
  • Enrollment: The number of people planned or included in a study.
  • Primary outcome: The main result the researchers want to measure in the trial.

References

  1. https://clinicaltrials.eu/trial/study-on-capsaicin-patch-and-amitriptyline-for-neuropathic-pain-in-head-and-neck-cancer-patients-in-remission/
  2. https://clinicaltrials.gov/study/2022-500898-13-00
  3. https://clinicaltrials.gov/study/2022-502151-54-00
  4. https://clinicaltrials.gov/study/2022-500897-32-00
  5. https://clinicaltrials.gov/study/2022-500899-66-00