Paracetamol for Cancer Pain

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

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Randomised, double-blind placebo controlled cross-over trial

Main goal:

Optimize the medical pain treatment for patients with advanced cancer disease

Study goal:

Measure paracetamol's additional analgesic effect in a situation where the patient is concomitantly treated with oral opioids eqv. morphine \> 100 mg/d.

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Detailed Description

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National multicenter study with an intention to include 50 patients. 6 days treatment, 3d in each arm. Mean pain score last 24 h: NRS =/\> 4 All drug treatment constant during the study period. The participants are allowed to take as much rescue opioids as necessary to have adequate relief.

Paracetamol/ placebo given orally 1000 mg x 4 daily, three days in each arm, direct crossover.

Daily scoring of pain relief, ESAS, overall satisfaction and rescue medication.

Conditions

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Advanced Cancer Opioid Use, Unspecified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo pills

Placebo tablets resembling paracetamol 500 mg are given as alternative 2 tablets 4 times daily

Group Type PLACEBO_COMPARATOR

placebo tablets

Intervention Type DRUG

Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol

oral paracetamol 4 g daily

Patients are given 2 tablets of 500 mg paracetamol on a regular basis 4 times daily

Group Type ACTIVE_COMPARATOR

paracetamol

Intervention Type DRUG

1000 mg 4 times daily

Interventions

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paracetamol

1000 mg 4 times daily

Intervention Type DRUG

placebo tablets

Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol

Intervention Type DRUG

Other Intervention Names

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Acetaminophen Suger pills

Eligibility Criteria

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Inclusion Criteria

* Adults (\> 18 years) of both sexes
* Diagnosed with advanced cancer disease
* Ongoing medicinal pain relief treatment in stable dosing with oral opiates equivalent to \> 100 mg oral morphine daily
* NRS median pain score last 24 hrs \> 4
* Able to take tablets (paracetamol) orally

Exclusion Criteria

* Mental or physical deficiency precluding data collection.
* Reduced liver function judged with bilirubin, INR and transaminases
* Anticoagulation with warfarin
* Ongoing use of NSAIDs or 5-HT3 antagonists, or use of such drugs last week
* Ongoing palliative radiation treatment or radiation treatment during the last 4 weeks.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No