osteoarthritis pain
Conditions
Interventions
For groups 1-6, the drug will not be given to all 7 patients of a group at the
same time. Initially, 1 patient will receive PG110 or the placebo. Then, at
least one day later, another patient will r
Sponsors
Abbott B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • • you have given your written consent to take part in this study; • you are between 18 and 75 years of age; • you are in good physical and mental health; • your body weight must be appropriate in relation to your height (between 50 and 110 kg); • for female volunteers: you are not pregnant, nor can you get pregnant (you are surgically sterile or your uterus has been removed or you have been post-menopausal - if you are over 50 years old, your last menstrual period must be at least one year ago; if you are 50 years or younger, your last menstrual period must be more than two years ago); • you are suffering from pain due to osteoarthritis of the knee; • no abnormalities are diagnosed during the screening; • Kellgren-Lawrence grade 2, 3 or 4 upon radiographic examination of the index knee
Exclusion criteria
Exclusion criteria: • you are (or have been) taking illegal drugs and/or are (or have been) using alcohol to excess; • you drink more than 21 units of alcohol per week; • you have had an operation during the past 6 months or you are planning to undergo an operation less than 6 months after administration of the study drug; • you have taken part in another clinical drug study during the last 3 months prior to the study; • you have donated blood during the last three months prior to the study; • you have hepatitis B or C or are HIV positive; • the study physician is of the opinion that you are not suitable for participation in this study; • you have clinically significant knee abnormalities which render you unsuitable for this study; • you are in so much pain that you cannot adhere to the medication restrictions as described in the Information Sheet on Study Restrictions (SF3131); • you cannot adhere to the contraceptive methods as described in the Information Sheet on Contraceptive Rules (SF1032); • you are bedridden or you are in a wheelchair; • you have had keyhole surgery of the knee during the last 6 months prior to the study; • you are planning to lose weight or to change your normal pattern of physical activity (your eating habits and your pattern of physical activity must be stable); • you have chronic pain due to fibromyalgia; • you are suffering from a mental disorder; • you have a neurological condition; • you faint regularly; • your memory is impaired; • you are suffering from a clinically significant cardiovascular disorder; • you have cancer or have had cancer in the past; • you have a relevant drug allergy or you are hypersensitive to medication; • you have clinically relevant abnormalities in the opinion of the PI in serum chemistry, hematology and urinalysis.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondly, we will investigate the rate at which the study drug is absorbed into the body. Thirdly, we will investigate whether the body develops antibodies to the study drug (this is known as *immunogenicity*). Lastly, we will investigate the effect of the study drug on the body. | — |
Primary
| Measure | Time frame |
|---|---|
| Firstly, we will investigate the safety and tolerability of the study drug following administration of a single escalating dose of the drug. | — |
Countries
Netherlands
Outcome results
None listed