A clinical trial to study the effects of Maxigesic (paracetamol 500mg + ibuprofen 150 mg) with the other 3 treatment groups (paracetamol 500 mg; low dose ibuprofen 150 mg; high dose ibuprofen 300mg) in patients who have painful osteoarthritis of the knee.

Phase 2

Completed

• Conditions: Health Condition 1: null- Osetoarthrites of Knee

• Registration Number: CTRI/2009/091/000096
• Lead Sponsor: AFT Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

1.Provide written informed consent before initiation of any study-related procedures

2.Symptoms of OA of the knee for at least 6 months which has required analgesic medication

3.Be between 45-80 years of age inclusive on the day of consent

4.Physician opinion that long term medication for treatment of painful OA is indicated

5.Painful osteoarthritis of the study knee determined by the investigator with an average pain score of at least 40 and no more than 80mm on the WOMAC VAS pain scales following a 3-7 day washout of existing analgesics

Exclusion Criteria

Patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization:

Study contra-indications
1.Symptoms of OA of both the knee and the hip that require treatment
2.Weight less than 50kg
3.Rheumatoid arthritis or other inflammatory arthritis
4.Gout or recurrent episodes of pseudogout
5.Paget?s disease
6.Articular fracture
7.Onchronosis
8.Acromegaly
9.Haemochromatosis
10.Wilson?s Disease
11.Primary Osteochondromatosis
12.Heritable disorders (e.g. hypermobility)
13.Oral or parenteral corticosteroids within 2 months or intra-articular hyaluronic acid within 9 months
14.Having taken any single dose of an NSAID or paracetamol within 12 hours prior to first dose of study drug
15.Known to be pregnant or possibly pregnant (serum -HCG test positive)
16.Woman of child bearing age who, in the opinion of the investigator, are not using reliable contraception
17.Alcohol intake
18.Suffering from a neurological disorder relating to pain perception
19.In the opinion of the investigator, unable to understand the visual analogue pain score
20.Currently, or in last 30 days, participating in a clinical trial involving another study drug
21.Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the patient?s best interests to participate in this study

NSAID and/or paracetamol contra-indications
1.Hypersensitivity to aspirin or other NSAID
2.Hypersensitivity to paracetamol
3.Severe known haemopoetic, renal or hepatic disease, immunosuppressed
4.History of gastric ulceration, indigestion, stomach pain or GI bleeding or bleeding disorders
5.Currently suffering from dehydration through diarrhoea and/or vomiting
6.History of severe asthma defined as previous steroid treatment or hospital admission

Study & Design

• Study Type: Interventional
• Study Design: Not specified