Tolerability study of Maxigesic in patients with Mild to Severe Pain

Maxi-Analgesic Tolerability Study: Open-Label, Phase IV, Multi-Centre Clinical Trial to Evaluate the Safety and Tolerability of Maxigesic in Patients with Mild to Severe Pain.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000598088

Enrollment

600

Registered

2010-07-23

Start date

2010-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Both paracetamol and ibuprofen are relatively safe when administered at over the counter (OTC) dose and their safety profile has been well-estabilished for many years. A combination of paracetamol and ibuprofen has been proved to be more effective than each individual component in a phase 3 clinical trial in an acute pain model (ACTRN:12606000291583). However, the safety observation in the same trial is only for 48 hours. In many clinical circumstances, the pain relief period is required to be up to 14 days such as post-operative pain relief for some moderate surgery. At the same time, it is proposed to observe the safety profile for long term use (up to 3 months) in patients with chronic pain.

Interventions

Interventions: The combination of paracetamol and ibuprofen (paracetamol 500 mg + ibuprofen 150 mg per tablet) Treatment Period: Acute Pain Treatment group: 2 tablets every 6 hours for a minimum of 48 hours to 14 days Chronic Pain Treatment group: Fixed dosing group: 2 tablets every 6 hours between 15 days and 3 months Flexible dosing group: 1-2 tablets every 4 or 6 hours up to a maximum of 8 tablets per day between 15 days and 3 months

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Provide written informed consent before initiation of any study-related procedures Be aged at least 18 years and not more than 80 years old on the day of consent Require treatment of mild to severe pain due to either acute or chronic pain Acute pain includes: Dental pain including tooth/teeth extraction; Post-operative pain after minor surgery e.g. cutaneous surgery, hernia; Post-operative pain after moderate surgery e.g. orthopaedic surgery, abdominal surgery, episiotomy; Muscle and ligament sprain; Skeletal trauma;Dysmenorrhoea Chronic pain includes: Osteoarthritis;Rheumatoid arthritis; Low back pain

Exclusion criteria

Has taken any NSAID or paracetamol within 12 hours prior to study initiation other than aspirin less than or equal to 150mg/day for prevention of cardiovascular disease. Has taken another analgesic other than paracetamol or an NSAID within 3 days prior to study initiation. Known to be pregnant or possibly pregnant. Has been in a clinical trial involving another study drug in last 30 days prior to baseline. Currently treated with an angiotensin-converting enzyme (ACE) inhibitor, warfarin, steroid (other than dexamethasone intra-operatively), cyclosporin, tacrolimus or methotrexate. Patient weight < 50kg at baseline. Is suffering from any other disease or condition which, in the opinion of the investigator, means that it would not be in the patient’s best interest to participate in this study. Has any of the following NSAID and/or paracetamol contra-indications: Hypersensitivity to aspirin or other NSAID Hypersensitivity to paracetamol Severe known haemopoetic, renal or hepatic disease, immunosuppressant History of gastric ulceration, indigestion, stomach pain or bleeding Currently suffering from dehydration through diarrhoea and/or vomiting History of severe asthma defined as previous steroid treatment or hospital admission

Outcome results