Pain – Trials in Disease

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Ongoing Clinical Trials Related to Pain

This article provides an overview of 13 ongoing clinical trials focused on pain management across various contexts, including chronic pain, acute pain, postoperative pain, and neuropathic pain. These trials are evaluating different treatment approaches such as opioid medications, local anesthetics, anti-inflammatory drugs, and combination therapies across multiple countries including Spain, Netherlands, France, Germany, Austria, Norway, Denmark, Poland, Bulgaria, Hungary, and Czechia.

Clinical trial locations

Comparing Buprenorphine/Naloxone and Methadone for Opioid Use Disorder in Patients with Chronic Pain: A Study on Reducing Opioid Misuse

This trial is being conducted in the Netherlands and focuses on individuals dealing with both opioid use disorder and chronic non-cancer pain. Participants must be at least 18 years old and currently taking prescribed opioids at a daily dose equivalent to more than 60 mg of morphine for at least three months. They must also have a diagnosis of opioid use disorder and be willing to receive treatment for it.

The study compares two medications used to treat opioid dependency. Suboxone, a combination of buprenorphine and naloxone, is taken as a sublingual tablet that dissolves under the tongue. Buprenorphine partially activates opioid receptors in the brain to reduce cravings and withdrawal symptoms, while naloxone prevents misuse. Methadone, taken orally, is a full opioid agonist that helps stabilize patients by reducing withdrawal symptoms and cravings with a longer duration of action.

Participants will be randomly assigned to receive either Suboxone or methadone and will be monitored for several months. The main goal is to compare how effectively these treatments reduce opioid misuse, with assessments occurring at two and six months after starting treatment. Throughout the study, participants will complete questionnaires and undergo various tests to track their progress.

Study Comparing Low-Dose Esketamine and Ketamine for Severe Acute Pain in Emergency Department Patients

This French trial evaluates treatments for severe acute pain in emergency department settings. Eligible participants must be adults aged 18 or over experiencing acute severe pain that started less than seven days ago, with a pain rating of 6 or higher on a 0 to 10 scale. They must provide informed consent and be affiliated with a social security scheme.

The study compares ketamine, administered intravenously at 0.3 mg per kilogram of body weight, with esketamine, given at 0.15 mg per kilogram. Both medications are used to manage pain and work by blocking NMDA receptors in the brain. The primary focus is to assess the occurrence of psychodysleptic effects, which are unusual mental or sensory experiences, during the first hour after treatment.

Participants will be monitored every five minutes for one hour after receiving medication, with assessments of pain relief effectiveness and any additional pain relief needs. The intensity of unusual effects and other side effects will be recorded every 15 minutes during this period.

Study on Duloxetine for Reducing Chronic Pain After Inguinal Hernia Surgery in High-Risk Patients

This Spanish trial investigates whether duloxetine can reduce the risk of developing chronic pain after inguinal hernia repair surgery. Participants must be men living in Spain who are scheduled for open inguinal hernia repair and have a 27% or higher risk of developing chronic post-surgical pain, as measured by the GENDOLCAT risk scale.

Duloxetine is a serotonin-norepinephrine reuptake inhibitor typically used to treat depression and anxiety. In this study, it is administered as a 30 mg oral capsule that resists stomach acid. Participants will receive either duloxetine or a placebo around the time of surgery and continue taking it as directed by the study protocol.

The main goal is to determine if duloxetine can lower the incidence of chronic pain four months after surgery. Participants will be monitored for changes in quality of life using questionnaires and any side effects that occur during the study period.

Study on the Effectiveness and Safety of Ibuprofen and Tramadol for Patients with Severe Postoperative Pain

This trial in Spain tests a combination treatment for acute severe postoperative pain following surgeries such as myomectomy, hysterectomy, or cholecystectomy. Eligible participants must be at least 18 years old, have a body mass index between 18.5 and 35, and be scheduled for one of the specified surgeries. After surgery, they must experience a pain score of 6 or higher on the Numeric Rating Scale.

The investigational treatment combines ibuprofen (arginate) and tramadol hydrochloride, administered intravenously at a dose of 400-37.5 mg. Ibuprofen reduces inflammation by inhibiting enzymes that produce inflammatory chemicals, while tramadol alters pain perception by affecting neurotransmitters in the brain. The treatment is given every four hours.

The study compares this combination to tramadol alone and a placebo, measuring pain intensity at baseline and at regular intervals up to 48 hours after treatment begins. The primary goal is to evaluate the change in pain intensity over the first four hours, with assessments of overall pain relief and time to significant pain reduction.

Study of ropivacaine, sodium chloride and gadoteric acid in nerve blocks for hip pain in healthy volunteers

This Danish trial compares two types of nerve blocks for hip pain management: the subpectineal obturator nerve blockade and suprainguinal fascia iliaca compartment block. Participants must be at least 18 years old, have a body mass index less than 25 kg/m², weigh 69 kilograms or more, and be classified as ASA I or II (healthy or having only mild systemic disease). They must be able to read and understand Danish and provide informed consent.

The study involves injecting medications near specific nerves to provide pain relief. Ropivacaine, a local anesthetic, and sodium chloride solution are used during the procedures. Dotarem, a contrast agent containing gadoteric acid, is used for MRI imaging to visualize how the medication spreads.

Throughout the study, participants undergo muscle strength measurements using a dynamometer, electrical muscle signal testing with EMG, and skin sensation testing to measure areas of numbness. The goal is to determine how effectively these nerve blocks reduce sensation in specific nerves, particularly the obturator nerve.

Study on Frozen Shoulder: Evaluating the Effectiveness of Physiotherapy, Triamcinolone Acetonide, and Lidocaine in Improving Shoulder Function and Reducing Pain

This Norwegian trial addresses frozen shoulder, a condition causing pain and stiffness in the shoulder joint. Participants must have experienced shoulder pain for less than nine months and have reduced passive range of movement compared to the other shoulder, with a difference greater than 30 degrees in at least two movements. They must experience shoulder pain greater than 3 on a 0 to 10 scale during activity or rest and be between 18 and 70 years old.

The study evaluates three treatment approaches: physiotherapy alone, corticosteroid injections alone, and a combination of both. The corticosteroid used is triamcinolone acetonide, combined with lidocaine, a local anesthetic. These are injected directly into the shoulder joint to reduce inflammation and pain.

Participants will be assigned to one of the treatment groups and monitored over three months. The study will assess improvements using the Shoulder Pain and Disability Index and other measures, including range of motion and pain levels, to determine which treatment or combination provides the best relief.

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

This trial, conducted in Austria and Germany, evaluates AP707 as an additional treatment for chronic pain due to central neuropathy, which results from nerve damage in the central nervous system. Participants must be at least 18 years old, have chronic pain for at least three months with a pain intensity of 5 or more on a 0 to 10 scale, and have optimized standard pain treatment at the start of the study. They must also have good command of the German language.

AP707 is administered as a sublingual spray, meaning it is sprayed under the tongue for absorption. Participants will receive either AP707 or a placebo for 52 weeks, during which their pain levels will be monitored using a simple scale. The study will also evaluate quality of life, sleep quality, and psychological well-being.

The main goal is to determine if AP707 can provide significant relief from chronic pain caused by nerve damage in the central nervous system and improve quality of life. Throughout the study, participants will complete regular questionnaires and undergo assessments at 14, 26, and 52 weeks to track progress.

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

This trial in Austria and Germany studies AP707 for chronic pain resulting from nerve damage after injury or surgery. Participants must be at least 18 years old, have chronic pain for at least three months with a pain intensity of 5 or more on a 0 to 10 scale, and have optimized standard pain treatment. They must also have good command of the German language.

AP707 is administered as a pump spray for sublingual application, used under the tongue. Participants will be randomly assigned to receive either AP707 or a placebo for 52 weeks, while continuing their regular pain medications, which may include gabapentin, capsaicin, imipramine, amitriptyline, and paracetamol.

The study aims to determine if adding AP707 to current treatment can make a difference in managing this type of pain. Participants will rate their pain levels regularly and complete questionnaires to monitor changes. Assessments will occur at 14, 26, and 52 weeks to evaluate the effectiveness and tolerability of the treatment.

Study on Pain Relief After Dental Surgery Using Ibuprofen Arginine and Tramadol Hydrochloride for Patients with Moderate to Severe Pain

This Spanish trial evaluates a combination treatment for moderate to severe pain following wisdom tooth extraction. Participants must be at least 18 years old, have a body mass index between 18.5 and 35, and be scheduled for surgical removal of at least two third molars, with at least one being a lower impacted tooth requiring bone removal. After surgery, they must experience a pain level of at least 55 mm on the Visual Analogue Scale within the first three hours.

The treatment combines ibuprofen (arginine) and tramadol hydrochloride in granules for oral solution, with a dosage of 400 mg/37.5 mg. Ibuprofen reduces inflammation and tramadol acts as a pain reliever. The medication is administered orally every six hours.

The study compares this combination to each medication taken alone and to a placebo, measuring pain intensity at scheduled times up to 48 hours after treatment begins. The primary goal is to measure the sum of pain intensity differences over 12 hours, with additional assessments of overall pain relief and time to first pain relief.

Study on Reducing Pain During IV Catheter Insertion in Adult Women Using 10% Lidocaine Spray

This Austrian trial evaluates the effectiveness of a 10% lidocaine spray in reducing pain during the insertion of a peripheral intravenous catheter in adult women. Participants must be female volunteers aged 18-45 years with a personal history of having had a venipuncture or PIVC insertion.

Lidocaine is a local anesthetic that helps numb the area where it is applied. The spray is applied to the skin shortly before catheter insertion. Participants will receive either the lidocaine spray or a placebo, and their pain levels will be measured using the Numerical Rating Scale, which allows individuals to rate their pain on a scale from 0 to 10.

The study will specifically look at pain levels in two areas: the back of the hand and the forearm. By comparing pain levels between those who receive the lidocaine spray and those who receive the placebo, researchers hope to determine the spray’s effectiveness in reducing pain during this common medical procedure.

Study on the Effectiveness of ODM-111 and Paracetamol for Chronic Pain in Patients with Diabetic Peripheral Neuropathy

This trial, conducted across Poland, Bulgaria, Hungary, Germany, and Czechia, evaluates ODM-111 for chronic pain due to diabetic peripheral neuropathy. Participants must be between 18 and 80 years old, have a body mass index between 18 and 45 kg/m², and have Type 1 or Type 2 diabetes for at least six months with well-controlled blood sugar levels. They must have been diagnosed with painful diabetic peripheral neuropathy for at least six months, with pain mainly in the legs and an average pain intensity of a specified level on a 0 to 10 scale.

ODM-111 is administered orally in tablet form. Participants will receive either ODM-111 or a placebo, and their pain levels will be monitored over six weeks. Throughout the study, participants will record their daily pain levels using a numerical scale to help assess changes in pain intensity.

The study also involves the use of Para-Tabs, which contain paracetamol, a common pain reliever. The goal is to provide information on the potential benefits of ODM-111 for managing chronic pain due to diabetic peripheral neuropathy and to assess how well patients tolerate the medication.

Summary

These 13 clinical trials represent a diverse range of approaches to managing different types of pain. A notable concentration of studies is taking place in Spain, which hosts four trials focusing on postoperative and dental pain management. Germany and Austria together host three trials examining treatments for neuropathic pain conditions.

Several trials focus on combination therapies, particularly those pairing anti-inflammatory medications like ibuprofen with opioid analgesics such as tramadol. Three trials specifically evaluate the investigational drug AP707 as an add-on treatment for various types of neuropathic pain. Multiple studies address pain in specialized populations, including children, patients with diabetes-related nerve damage, and individuals with opioid use disorder.

The trials employ diverse assessment methods, from standard pain scales to more complex sensory testing and quality of life questionnaires. Treatment durations vary considerably, from short-term evaluations of acute pain relief in emergency settings to year-long studies of chronic pain management. This variety reflects the complexity of pain management and the ongoing search for more effective and safer treatment options across different patient populations and clinical contexts.

Ongoing Clinical Trials on Pain

  • Comparison of bovine and marine chondroitin sulfate tablets (800 mg) in treating knee osteoarthritis pain and functional impairment

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Hungary Poland
  • Comparing Buprenorphine/Naloxone and Methadone for Opioid Use Disorder in Patients with Chronic Pain: A Study on Reducing Opioid Misuse

    Recruiting

    3 1 1 1
    Investigated diseases:
    The Netherlands
  • Study comparing oral and injectable nefopam in patients with acute rheumatologic pain to evaluate how the medication is processed by the body

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France
  • Study on Reducing Pain During IV Catheter Insertion in Adult Women Using 10% Lidocaine Spray

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria
  • Study on the Effects of Tetrodotoxin for Pain Relief in Healthy Volunteers

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands
  • Study on the Safety and Pain Relief of Nasal Spray with Ketamine Hydrochloride and Sufentanil Citrate for Children with Moderate to Severe Pain

    Not recruiting

    2 1 1
    Investigated diseases:
    Spain
  • 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:
    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:
    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:
    Austria Germany