A study to compare the effect of a new formulation of ibuprofen with a standard prescription dose of ibuprofen in the treatment of knee pain.
- Conditions
- Episodic knee arthralgia/flaring knee painMedDRA version: 18.1Level: PTClassification code 10003239Term: ArthralgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2014-004254-33-GB
- Lead Sponsor
- Infirst+ HEALTHCARE Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 486
1: Male or female subjects between 18 and 70 years of age on the day of signing informed consent.
2: Noticeable pain in the index knee joint lasting >48 h at least once during the previous 12 months either non treated or, requiring non-steroidal anti-inflammatory drugs (NSAIDs).
3: Subjects must rate knee pain as 5 or above based on pain specific NRS.
4: Willingness to abstain from the use of non-study pain medication (apart from paracetamol taken as advised by the Investigator, if required) from the time of onset of knee flare until receipt of study medication.
5: Willingness to abstain from use of NSAIDs (oral and topical other than those given as study treatment), other topical pain therapies (e.g., capsaicin), corticosteroids (systemic and intra articular), viscosupplementation, and other pharmacological pain treatments during the study.
6: Female subjects of childbearing potential must have a negative urine pregnancy test at baseline unless they are surgically sterile or have been post menopausal for = 1 year (12 consecutive months without menses).
7: Female subjects of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 30 days after the last dose of study treatment. Medically acceptable forms of birth control include, oral contraceptives, injectable or implantable methods, intrauterine devices, tubal ligation (if performed > 1 year before baseline ), or double barrier contraception.
8: Subjects must be able to understand and be willing to sign the informed consent prior to randomisation and agree to the study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 316
1: History of serious illness or disease (e.g. progressive neurological signs, septic arthritis, fractures or significant injury or surgery to the knee(s), as per investigators opinion, in the last 3 months.
2: Subjects who have undergone cholecystectomy.
3: BMI < 18 or >39 kg/m2 or a body weight <40 kg.
4: Diagnosis of systemic lupus erythematosus (SLE), mixed connective tissue disorders or autoimmune arthritis (e.g. rheumatoid arthritis, psoriatic arthritis) or receiving disease modifying anti-rheumatic drugs (DMARDs) or biologics.
5: Diagnosis of gout or use of allopurinol, febuxostat, colchicine.
6: Intra-articular corticosteroid to the index knee joint within 3 months prior to baseline visit or to any other joint within 4 weeks prior to baseline; hyaluronic acid intra-articular injection to the index knee joint within 6 months prior to baseline visit; systemic corticosteroids (oral, intramuscular or intravenous) within 4 weeks prior to baseline visit.
7: Radiotherapy for chronic articular pain within 3 months prior to baseline visit or planning the initiation of such therapy during the study.
8: Pain medication
Medications for treating chronic pain (this refers to all pain medications including but not limited to, long term regular use of NSAIDs, opiates, anticonvulsants, tricyclic antidepressants, selective serotonin reuptake inhibitors, norepinephrine reuptake inhibitors, etc.) within 4 weeks prior to baseline visit; [Note long term regular use is full daily dose are recommended on SmPC or prescribed, daily, for a minimum of 2 consecutive weeks].
Pain medications taken on an intermittent basis are permitted as long as a dose has not been taken within 7 days prior to baseline visit and are not taken throughout the duration of the study (this includes NSAIDs and opiates).
9: Subjects taking selective serotonin reuptake inhibitors [SSRIs]
10: Any medication taken to alleviate pain specifically related to the current knee pain and prior to first dose of study medication other than a single dose of 2 x 500 mg of paracetamol.
11: Clinically relevant history of hypersensitivity or allergy to study treatment or any other constituent of the drug: History of asthma, acute rhinitis, angioedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid, ibuprofen, or other NSAIDs, including COX-2 inhibitors.
12: Any medical condition that could interfere with the study evaluations e.g., anatomical deformities, fibromyalgia, chronic pain syndrome and neuropathy which would interfere with the assessment of pain.
13: Severe heart failure and congestive heart failure; history of clinically significant cardiovascular disease including, but not limited to, myocardial infarction, unstable angina, peripheral arterial disease, and stroke or transient ischemic attack; uncontrolled hypertension.
14: Active or previous history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) or history of gastrointestinal bleeding or perforation related to previous NSAIDs therapy; history of gastrointestinal bleeding, history of inflammatory bowel disease.
15: Subjects with severe hepatic insufficiency.
16: Subjects with renal function GFR <60 mL/min/1.73 m2 based on the MDRD equation
17: Subjects with rare hereditary problems of fructose intolerance.
18: Any clinically significant condition that in the Investigator’s judgment may affect efficacy or safety assessments or may
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method