Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
43 participants
INTERVENTIONAL
2018-08-20
2022-08-31
Brief Summary
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Detailed Description
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The secondary objectives will be:
* To determine the number of patients in whom paracetamol is effective in reducing pain by at least 30% and 50%,
* To evaluate the effect of paracetamol on pain, on the number and intensity of paroxysms,
* To evaluate paracetamol consumption,
* To evaluate the effect of paracetamol on neuropathic pain patient,
* To evaluate the effect of paracetamol on mechanical allodynia,
* To monitor routine biological parameters (liver function),
* Compare Glutathione (GSH) concentrations before and after taking paracetamol,
* To perform a blood test for paracetamol and its metabolites before and after each study period,
* To perform urine dosage of paracetamol and its metabolites before and after each study period,
* To study pharmacogenetics parameters,
* To evaluate patient feeling and satisfaction after taking paracetamol,
* To evaluate the effect of paracetamol on cognition, anxiety, depression and sleep by different questionnaires,
* To collect adverse events.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
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).
Study Groups
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Paracetamol and placebo comparator (Group 1)
Neuropathic pain patients taking either paracetamol or placebo according to the randomization plan
paracetamol
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.
Placebo comparator
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 2)
Neuropathic pain patients taking either paracetamol (if during period 1 they received placebo) or placebo (if during period 1 they received paracetamol)
paracetamol
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.
Placebo comparator
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.
Interventions
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paracetamol
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.
Placebo comparator
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.
Eligibility Criteria
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Inclusion Criteria
* 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,
* Patient agrees with not to take paracetamol, other than the treatment provided as part of the protocol, from inclusion to completion of the study,
* Acceptance to give a written consent.
Exclusion Criteria
* 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 participating in another clinical trial, or being in an exclusion period, or having received a total amount of compensation exceeding 4500 euros over the 12 months preceding the start of the trial,
* 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.
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Gisèle PICKERING
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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Lise LACLAUTRE
Clermont-Ferrand, , France
Countries
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Other Identifiers
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2017-004505-40
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-389
Identifier Type: -
Identifier Source: org_study_id
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