A clinical trial to investigate the safety and effect of a drug called PRX167700 on painful chronic conditions such as osteoarthritis in the knees.
- Conditions
- Osteoarthritis of the kneeMedDRA version: 16.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-001970-33-GB
- Lead Sponsor
- Proximagen Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
The study inclusion criteria are:
1. Male or female subjects aged between 45 and 75 years inclusive.
Female subjects are eligible to participate in the study if they are not of child-bearing potential or, if of child-bearing potential, are not pregnant or lactating; agree to use an acceptable method of contraception during the study. Female subjects should have a negative pregnancy test at Screening and Visit 2.
2. Body Mass Index (BMI) between 20 and 35 kg/m2, inclusive.
3. Symptomatic primary OA of the knee for at least 3 months prior to Screening according to the American College of Rheumatology (ACR) criteria.
4. Diagnosis of OA of the knee based on ACR criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of =2) in the target knee joint. One knee should be designated as the target joint. The pain in the target knee joint should exceed the pain experienced in other joints (including the contralateral knee joint and/or ipsilateral hip joint) and pain experienced from any concomitant medical condition.
ACR Clinical and radiographic diagnostic criteria consist of knee pain plus osteophytes, plus at least 1 of the following 3 criteria:
i. Age >50 years
ii. Morning stiffness <30 minutes in duration
iii. Crepitus on active motion of the weight-bearing knee.
5. Use of analgesics for the treatment of knee OA for at least 4 out of 7 days in each of the 4 weeks preceding the Screening visit.
6. Willing and able to discontinue all current analgesic therapy, including over the counter (OTC) pain medications and topical analgesics for OA pain, for a period beginning at Screening and continuing for the entire duration of the study.
7. Able to walk 100 metres on a flat course without rest and unaided. A single simple walking stick/cane is permitted (tripod designs and those with forearm support not permitted).
8. A self-rated PI score in the target knee joint of between 3 and 8, inclusive at Screening, immediately after a timed 100 metres walk on a flat course.
9. Able to provide written informed consent to participate in the study and, in the opinion of the investigator, able to read, comprehend and record information as required by the protocol.
10. An increase in Screening Pain Intensity score of at least 1 point in the target knee joint immediately after a timed 100 metres walk on a flat course at Visit 2.
11. Compliant with placebo dosing instructions during Washout Period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37
1. Secondary causes of arthritis of the knee, including septic arthritis, inflammatory joint disease, crystalline diseases, articular fracture, and inherited disorders.
2. Disease of the spine or of lower extremity joints (other than OA) which may affect the assessment of pain in the target knee joint.
3. Pain relating to target knee joint that has characteristics of neuropathic pain (e.g. shooting or burning pain, pins and needles, allodynia).
4. Has had lower extremity surgery (including arthroscopy) within 6 months prior to Screening or scheduled for surgery of any kind during the study.
5. Significant injury to the target knee joint within 12 months prior to Screening.
6. Known history of hypersensitivity or intolerance to paracetamol or lactose.
7. Corticosteroid injections before Screening:
i. Intra-articular into the target knee joint within 3 months
ii. Intra-articular into any site other than the target knee joint within 1 month
iii. Intra-muscular within 3 months
8. Oral corticosteroids within 1 month of Screening.
9. Other therapeutic injections into the target knee joint within previous 3 months.
10. Use of any anti-inflammatory biological therapy within 12 months or methotrexate within 1 month prior to Visit 2.
11. Start or change in dosing regimen of other therapies for OA within 3 months of Screening.
12. Start or change in an established physiotherapy programme within 2 weeks of Screening or during the course of the study. An established physiotherapy program may be continued throughout the study period if unchanged in frequency and intensity.
13. Any clinical or biological abnormality found at screening (other than those related to OA) which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study (e.g. current malignancy, human immunodeficiency virus (HIV) infection, significant mental illness).
14. Clinically significant illness other than OA within 3 months prior to Screening.
15. History of malignancy within past 5 years (except for basal cell carcinoma or carcinoma-in-situ of the cervix treated with curative intent). Subjects with a history of melanoma, leukaemia, lymphoma, or myeloproliferative disease are ineligible for the study regardless of the time since treatment.
16. QTc =450 msec or, for subjects with bundle branch block, QTc >480 msec.
17. Uncontrolled hypertension at Screening: systolic blood pressure (SBP) >160 mmHg and/or sitting diastolic blood pressure (DBP) >90 mmHg. Hypertension controlled by medications is acceptable, as long as stable for at least one month prior to Screening.
18. Presence of congestive heart failure (New York Heart Association [NYHA] functional class II-IV).
19. Bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN) or two or more of bilirubin, ALT or AST above the ULN at Screening.
20. Chronic Hepatitis B or C, as evidenced by positive Hepatitis B surface antigen (HbsAg) or Hepatitis C antibody at Screening.
21. History of chronic alcoholic liver disease, drug or alcohol dependence.
22. Renal dysfunction at Screening, defined as estimated glomerular filtration rate <30 ml/min.
23. Use of potent inducers or inhibitors of CYP3A4 or inhibitors of CYP2D6 within 48 hours or 5 half-lives prior to Visit 2.
24. Receipt of an investigational product within 30 days or 5 half-lives or twice th
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