Osteoarthritis Clinical Trial
Official title:
A Single-Blind, Multiple Ascending-Dose Pilot Study of the Safety, Tolerability, Pharmacokinetics, and Effectiveness of Orally Administered CR845 in Patients With Osteoarthritis of the Hip or Knee
To assess the safety and tolerability of orally-administered CR845 in patients with osteoarthritis (OA) of the hip or knee. The study drug is being tested to reduce OA pain, and will be taken twice a day for two weeks, with four different doses (strengths) being tested. From screening period to follow up examination, the study is expected to last for up to 38 days per participant.
The purpose of this clinical study is to collect information on the effectiveness of CR845
and to look at the safety of different dose levels of CR845 tablets. Oral CR845 has been
tested in healthy people. This is the first time that oral CR845 is being tested in patients
with osteoarthritis.
Four different doses of CR845 will be tested in this study. Participants will be assigned to
one of the four treatment groups. The first 6 participants in each of the 4 treatment groups
will be given the study drug in an inpatient study unit (clinic) for approximately 2 days.
Frequent blood samples will be taken to measure drug levels during these 2 days. Also,
because the study drug (CR845) is known to increase urination during the first day, the
amount of fluid that participants drink and the amount of urine that they void during the
first day will also be measured.
At the end of the second day, a member of the clinical staff will check vital signs and the
patient's laboratory results prior to discharge from the clinic. After that, the remainder
of the treatment period is as an outpatient (at home). This involves taking an additional
two tablets twice a day, and maintaining a diary that will be returned to the clinic upon
completion.
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