A study to compare the preference of two contrasting paracetamol formulations in the management of osteoarthritis pain

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12607000565448
• Date of registration: 01/11/2007
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Consumer Healthcare
• Public title: A study to compare the preference of two contrasting paracetamol formulations in the management of osteoarthritis pain
• Scientific title: A study to compare the preference of two contrasting paracetamol formulations in the management of osteoarthritis pain
• Date of first enrolment: 01/11/2007
• Target sample size: 260
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12607000565448.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Efficacy;
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Fiona Dunagan

• Name: Fiona Dunagan

Key inclusion & exclusion criteria

Inclusion criteria: At least 45 years of age, good general health, diagnosis of osteoarthritis of the knee with the pain worse in one knee, pain must be suitable for treatment with a simple analgesic
Exclusion criteria: History of a secondard cause of osteoarthritis, medical condition that may affect the ability to rate pain, any contraindication to the use of paracetamol or ibuprofen, intra-articular steroid injection to the knees within the last 2 weeks

Age minimum: 45 Years
Age maximum: -2147483648 No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Osteoarthritis

Osteoarthritis of the knee;
Osteoarthritis of the knee

Intervention(s)

All patients will receive both treatments. Two weeks treatment with immediate release paracetamol (1000mg four times daily - oral), and two weeks of extended release paracetamol (1330mg three times daily - oral). There is no washout period between the treatments.

Primary Outcome(s)

Patient preference for a particular treatment in the management of osteoarthritis pain[When patients have completed both 2 week arms of the study.]

Secondary Outcome(s)

Global assessment of response to treatment[At the end of each 2 week treatment period]

Night time disturbance due to knee pain[At the end of each 2 week treatment period]

Pain at rest[At the end of each 2 week treatment period]

Quality of sleep during the night[At the end of each 2 week treatment period]

Patient attitude towards treatment convenience[At the end of the study]

Overall experience of pain using a verbal rating scale.[At the end of each 2 week treatment period]

Compliance with medication[At the end of each 2 week treatment period]

Pain on walking[At the end of each 2 week treatment period]

Patient satisfaction with treatment using a verbal rating scale.[Completed at the end of each 2 week treatment period.]

Pain on waking[At the end of each 2 week treatment period]

Source(s) of Monetary Support

GlaxoSmithKline Consumer Healthcare

Ethics review

Status: Not approved
Approval date:
Contact: