Paracetamol and Neuropathic Pain

NCT03559985 | Terminated Phase 2

• 2 other identifiers: CHU-3892017-004505-40
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the analgesic effect of paracetamol in patients suffering from pain with a peripheral neuropathic component in the presence of their usual treatment.

Conditions

Neuropathic Pain

Keywords

Paracetamol; Neuropathic pain; Analgesic effect; Pharmacogenetics; Biological parameters; Cognitivo-emotional parameters

Outcome Measures

Primary Outcomes (1)

• Pain intensity change between period 1 and 2

  Pain intensity change between period 1 and 2, measured by numerical pain rating scale (NPRS) over one week (two evaluations per day, morning and evening) following the taking of paracetamol/ placebo.

  Day 1 to Day 7 (one week) and Day 15 to Day 21 (one week).

Secondary Outcomes (16)

• Treatment responders at 30% (NPRS)

  During 2 days before period 1 (mean of Day -1 and Day 0) and at the end of period 1 (mean of Day 6 and Day 7); during 2 days before period 2 (mean of Day 13 and Day 14) and at the end of period 2 (mean of Day 20 and Day 21).

• Treatment responders at 50% (NPRS)

  During 2 days before period 1 (mean of Day -1 and Day 0) and at the end of period 1 (mean of Day 6 and Day 7); during 2 days before period 2 (mean of Day 13 and Day 14) and at the end of period 2 (mean of Day 20 and Day 21).

• Number of paroxysms

  Before period 1 (Day -6 to Day 0), over a week during period 1 (Day 1 to Day 7), over a week during wash-out (Day 8 to Day 14) and over a week during period 2 (Day 15 to Day 21).

• Paroxysms intensity (NPRS)

  (Day -6 to Day 0), over a week during period 1 (Day 1 to Day 7), over a week during wash-out (Day 8 to Day 14) and over a week during period 2 (Day 15 to Day 21).

• Assessment of paracetamol (and placebo) consumption

  At Day1, Day8, Day15, Day22

Study Arms (2)

Paracetamol and placebo comparator (Group 1)

OTHER

Neuropathic pain patients taking either paracetamol or placebo according to the randomization plan

Drug: paracetamol; Other: Placebo comparator

Paracetamol and placebo comparator (Group 2)

OTHER

Neuropathic pain patients taking either paracetamol (if during period 1 they received placebo) or placebo (if during period 1 they received paracetamol)

Drug: paracetamol; Other: Placebo comparator

Interventions

paracetamol DRUG

Period 1 (D1 to D7): 500 mg (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day. Wash-out period (D8 to D14): patients should not take paracetamol during this week. Period 2 (D15 to D21): 500 mg per dose (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day.

Paracetamol and placebo comparator (Group 1); Paracetamol and placebo comparator (Group 2)

Placebo comparator OTHER

Period 1 (D1 to D7): 500 mg (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day. Wash-out period (D8 to D14): patients should not take paracetamol during this week. Period 2 (D15 to D21): 500 mg per dose (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day.

Paracetamol and placebo comparator (Group 1); Paracetamol and placebo comparator (Group 2)

Eligibility Criteria

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

You may qualify if:

• Patient aged 18 to 65 years,
• Patient suffering from chronic pain (for more than 3 months) with the characteristics of peripheral neuropathy and having pain assessed by a numerical scale ≥ 3 for one week, with at least 10 assessments completed,
• Acceptance to give a written consent.

You may not qualify if:

• Patient taking paracetamol daily,
• Patient with a contraindication to paracetamol administration (liver or renal failure, ...),
• Patient with a biological evaluation evaluated by the investigator as not compatible with the trial,
• Patient with a medical and/or surgical history evaluated by the investigator to be not compatible with the trial,
• Patient with drug treatments evaluated by the investigator to be not compatible with the trial,
• Pregnant or nursing woman,
• Patient with a cooperation and an understanding that does not allow for a strict compliance under the conditions set out in the protocol,
• Patient benefiting from a legal protection measure (curatorship, guardianship, protection of justice...),
• Patient not affiliated to the French Social Security system,
• Paracetamol intake during wash-out period.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Lise LACLAUTRE

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Gisèle PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Paracetamol 500 mg capsules (Doliprane® 500 mg) will remain packaged in their blister packs of origin. The necessary quantity of capsules will be packaged in a box labelled at the corresponding period (period 1 or 2). Lactose capsules (placebo) of the same size and colour as the Paracetamol capsules (Doliprane® 500 mg) will be bought by the CHU Pharmacy from Clermont-Ferrand. The capsules will then be blistered; the necessary quantity of capsules placebo will be packaged in the same box used for paracetamol, labelled at the time of the treatment (period 1 or 2).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After a week of pre-selection (D-6 to D0), each patient will receive successively in random order each of the 2 products (paracetamol and placebo) with one wash-out period of 7 days between each administration.

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: June 18, 2018
• Study Start: August 20, 2018
• Primary Completion: October 8, 2020
• Study Completion: August 31, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

FR (1)