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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
81
Subjects will dose orally twice a day with CR845 0.25 mg tablets for two weeks. A diary will be kept for recording the individual's pain scores and dosing accountability.
Subjects will dose orally twice a day with CR845 0.50 mg tablets for two weeks. A diary will be kept for recording the individual's pain scores and dosing accountability.
Subjects will dose orally twice a day with CR845 1 mg tablets for two weeks. A diary will be kept for recording the individual's pain scores and dosing accountability.
Heartland Clinical Research
Omaha, Nebraska, United States
Matthew Barton, MD
Las Vegas, Nevada, United States
Triad Clinical Trials, LLC
Greensboro, North Carolina, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
To assess the Safety and Tolerability of orally-administered CR845 in patients with osteoarthritis of the hip or the knee, in sequentially escalating doses (0.25 mg, 0.50 mg, 1 mg and 5 mg).
The sentinel group will be dosed and monitored in an inpatient clinic unit for 48 hours, then discharged to complete remainder of treatment at home. Following the evaluation of the first group's safety data, the remaining cohorts will begin enrolling. The safety and tolerability of CR845 will be assessed by physical examination, monitoring of adverse events, vital signs, laboratory evaluations, and fluid balance.
Time frame: Sentinel cohort initial 48 hours, all subjects 38 days
To characterize the pharmacokinetic (pk) profile of orally-administered CR845 with twice a day (b.i.d) dosing
The pharmacokinetic variables for the sentinel groups will have their plasma concentrations summarized and compared to pre-dosing.
Time frame: 48 hours
To explore the effectiveness of orally administered CR845 in this patient population
The effectiveness of CR845 will be assessed by the measurement of daily joint pain intensity scores (numeric rating scale \[NRS\]) over time, the impact of treatment on pain, function and stiffness (Western Ontario and McMaster Osteoarthritis Index \[WOMAC\] and global assessment of OA following treatment (Patient Global Assessment \[PGA\]).
Time frame: 38 days
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Subjects will dose orally twice a day with CR845 5 mg tablets for two weeks. A diary will be kept for recording the individual's pain scores and dosing accountability.
Clinical Investgations of Texas
Plano, Texas, United States