Study of Analgesic Action of Pregabalin, Duloxetine and Tramadol in Patients With Different Neuropathic Pain Phenotypes

NCT06252116 | Recruiting FDA Drug

• 1 other identifier: 3/28
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain is the most frequent cause from which millions of patients suffer worldwide, which makes them unable to work but also greatly affects their quality of life. Chronic pain is a condition in itself. Neuropathic pain is a consequence of damage or disease of the peripheral or central nervous system and presents a heterogeneous clinical profile. A large number of pharmaceutical and non-pharmacological agents, as well as various complementary therapies, have been used in the treatment of neuropathic pain. However, their effectiveness is considered moderate and limited and is under investigation because a significant proportion of patients do not respond satisfactorily to treatment. Purpose: The purpose of the study is to investigate the effectiveness of analgesics in the different phenotypes of neuropathic pain.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• NRS Scale assessment

  The initial assessment of the patients will be performed with the Numeric Rating Scale (NRS scale). NRS pain scale is a measure of pain intensity, in which the respondent selects a number from 0-10 that best reflects the intensity of his/her pain.

  1 month

Secondary Outcomes (1)

• Phenotype assessment

  1 month

Study Arms (1)

Neuropathic pain patients

Patients were randomized to pregabalin (group A) and duloxetine (group B). Those patients who did not have a 50% reduction in pain levels received duloxetine (group A) and pregabalin (group B). Then, those patients who did not have a 50% reduction in pain levels received tramadol.

Drug: Pregabalin group; Drug: Duloxetine group

Interventions

Pregabalin group DRUG

Pregabalin group

Neuropathic pain patients

Duloxetine group DRUG

Duloxetine group

Neuropathic pain patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients suffering from neuropathic pain (initial assessment with DN4 questionnaire)

You may qualify if:

• neuropathic pain

You may not qualify if:

• under 18 years old
• cancer pain
• patients receiving pregabalin, duloxetine, tramadol
• drug or alcohol abuse
• psychiatric decease
• renal failure, heart failure, liver failure, thrombocytopenia, closed-angle glaucoma

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

AHEPA University General of Thessaloniki, Chronic Pain Unit

Thessaloniki, 54636, Greece

RECRUITING

Related Publications (2)

• Campbell JN, Meyer RA. Mechanisms of neuropathic pain. Neuron. 2006 Oct 5;52(1):77-92. doi: 10.1016/j.neuron.2006.09.021.

  PMID: 17015228 BACKGROUND

• Freeman R, Baron R, Bouhassira D, Cabrera J, Emir B. Sensory profiles of patients with neuropathic pain based on the neuropathic pain symptoms and signs. Pain. 2014 Feb;155(2):367-376. doi: 10.1016/j.pain.2013.10.023. Epub 2013 Oct 25.

  PMID: 24472518 BACKGROUND

Related Links

• Peripheral neuropathic pain: from mechanisms to symptoms
• Usefulness and limitations of quantitative sensory testing: clinical and research application in neuropathic pain states

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ekaterini Amaniti, MD, PhD

  AHEPA University Hospital of Thessaloniki, Greece

  STUDY DIRECTOR

Central Study Contacts

Ioannis Dalakakis, MD, MSc

CONTACT

+306948536554; idalakakis@gmail.com

Ekaterini Amaniti, MD, PhD

CONTACT

+306937248827; amanitik@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: February 9, 2024
• Study Start: March 5, 2018
• Primary Completion: July 20, 2024
• Study Completion: September 7, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)