Trial · Interventional
CompletedPhase 2Registry dataA Study of the Safety and Effectiveness of Orally Administered CR845 in Patients With Osteoarthritis of the Hip or Knee
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 81 participants (actual)
- Sponsor
- Cara Therapeutics, Inc. · Industry
- Design
- Randomized · Single masking
- Countries
1 country
United States
- Start
- Aug 2015
- Primary completion
- Jan 2016
- Completion
- Jan 2016
- First posted
- 14 Aug 2015 (estimated)
- Last update posted
- 31 Jan 2017 (estimated)
- Conditions
- Osteoarthritis
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
A Study of the Safety and Effectiveness of Orally Administered CR845 in Patients With Osteoarthritis of the Hip or Knee
NCT02524197Aug 2015 to Jan 2016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- CR845 0.25 mgDrug
- CR845 0.50 mgDrug
- CR845 1 mgDrug
- CR845 5 mgDrug
Arms4
Active comparator
CR845 0.25 mg
Study medication will be taken b.i.d., in the morning (at least 2 hours before breakfast) and later in the afternoon (at least 2 hours before dinner), beginning on the morning of Day1 at the Baseline Visit. Analgesic rescue medication (Acetaminophen) for the treatment of pain will be provided at the Screening Visit. Patients will record their daily intake of study medication on the diary provided.
Active comparator
CR845 0.50 mg
Study medication will be taken b.i.d., in the morning (at least 2 hours before breakfast) and later in the afternoon (at least 2 hours before dinner), beginning on the morning of Day1 at the Baseline Visit. Analgesic rescue medication (Acetaminophen) for the treatment of pain will be provided at the Screening Visit. Patients will record their daily intake of study medication on the diary provided.
Active comparator
CR845 1 mg
Study medication will be taken b.i.d., in the morning (at least 2 hours before breakfast) and later in the afternoon (at least 2 hours before dinner), beginning on the morning of Day1 at the Baseline Visit. Analgesic rescue medication (Acetaminophen) for the treatment of pain will be provided at the Screening Visit. Patients will record their daily intake of study medication on the diary provided.
Active comparator
CR845 5 mg
Study medication will be taken b.i.d., in the morning (at least 2 hours before breakfast) and later in the afternoon (at least 2 hours before dinner), beginning on the morning of Day1 at the Baseline Visit. Analgesic rescue medication (Acetaminophen) for the treatment of pain will be provided at the Screening Visit. Patients will record their daily intake of study medication on the diary provided.
Primary outcomes1
Outcomes the sponsor listed as primary.
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).
Time frame · Sentinel cohort initial 48 hours, all subjects 38 days
Registry description
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.
Secondary outcomes(2)
To characterize the pharmacokinetic (pk) profile of orally-administered CR845 with twice a day (b.i.d) dosing
Time frame · 48 hours
Registry description
The pharmacokinetic variables for the sentinel groups will have their plasma concentrations summarized and compared to pre-dosing.
To explore the effectiveness of orally administered CR845 in this patient population
Time frame · 38 days
Registry description
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 \[PGA\]).
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 25 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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