Observational Study Aimed at Evaluating the Trend of Neuropathic Pain

Completed

• Conditions: Neuropathic Pain
• Interventions: Other: Peacetil

• Registration Number: NCT06324123
• Lead Sponsor: Istituto Auxologico Italiano

Brief Summary

The present study aims to evaluate the trend of neuropathic pain in patients treated with Peacetil for a period of two months.

Neuropathic pain will me assessed through the Numeric Rating Scale (NRS) questionnaire score.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-09
• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-21
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Patients with new or recent diagnosis of acute or chronic neuropathic pain in which the clinician decides to introduce treatment with PEACETIL according to common clinical practice, belonging to one of the following categories:

• Dysmetabolic polyneuropathy (e.g. diabetic neuropathy),

• Chemotherapy treatment neuropathy,

• Compressive mononeuropathy,

• Radiculopathy,

• Postherpetic and non-postherpetic trigeminal neuralgia;

  • The patient must be able to understand the informed consent of the study;
  • Must adhere to the procedures established by the study;
  • DN4 score >4 at T0 (month 0);

Read More

Exclusion Criteria

• Neurological disorders confounding the primary objective;
• Clinical condition which during the observational study requires the introduction or modification of the dosage of drugs which are also indicated for the treatment of acute or chronic pain
• Introduction or modification of the dosage of drugs used to treat acute and chronic neuropathic pain (including other nutraceuticals) from 30 days before the start of the study until the end of the study.
• Presence of unstable psychiatric illness, cognitive impairment, dementia, or substance abuse that would compromise the participant's ability to provide informed consent, as judged by the investigator;
• Clinically significant unstable medical condition (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, serious laboratory test abnormality, or clinically significant ECG changes) that would pose a risk to the participant if they were to participate in the study, in the judgment of the 'investigator.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with neuropathic pain	Peacetil	Patients with acute or chronic neuropathic pain

Primary Outcome Measures

Name	Time	Method
Change in neuropathic pain after two months of treatment with Peacetil	At enrollment and at two months after the start of treatment with Peacetil	Assessed by the Numerical Rating Scale (NRS) score

Secondary Outcome Measures

Name	Time	Method
Change in neuropathic pain after one month of treatment with Peacetil	At enrollment and at one month after the start of treatment with Peacetil	Assessed by the Numerical Rating Scale (NRS) score

Trial Locations

Locations (3)

Istituto Auxologico Italiano; 🇮🇹 Milan, Lombardy, Italy

ASST Fatebenefratelli Sacco; 🇮🇹 Milano, Italy

Fondazione Don Carlo Gnocchi ONLUS; 🇮🇹 Milano, Italy