Trial Outcomes & Findings for Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery (NCT NCT00877799)

Last Updated: 2015-05-12

Results Overview

The primary efficacy endpoint was the percentage of treatment responders compared to placebo. A responder was defined as a subject who had at least a 40% reduction in their pain intensity score and a pain relief score of "some," "a lot," or "complete" at 15 and 30 min following the start of the study drug infusion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

114 participants

Primary outcome timeframe

15 and 30 minutes after study drug administration

Results posted on

2015-05-12

Participant Flow

Two cohorts of patients were enrolled in this study in sequential order. Based on interim analysis of the results for Cohort 1 where study drug was administered 24 hours following surgery, the protocol was revised to administer the study drug immediately following surgery when patients were more likely to report a higher level of pain.

Participant milestones

Participant milestones
Measure	Cohort 1: Placebo Matched Placebo administered 24 hours post-surgery (Day 1)	Cohort 1: CR845 0.008 mg/kg CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)	Cohort 1: CR845 0.024 mg/kg CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)	Cohort 2: Placebo Matched Placebo administered within 3 hours after surgery (Day 0)	Cohort 2: CR845 0.040 mg/kg CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours after surgery (Day 0)
Cohort 1: 24 Hours After Surgery (Day 1) STARTED	25	22	21	0	0
Cohort 1: 24 Hours After Surgery (Day 1) COMPLETED	22	17	18	0	0
Cohort 1: 24 Hours After Surgery (Day 1) NOT COMPLETED	3	5	3	0	0
Cohort 2: Immediately Post-op (Day 0) STARTED	0	0	0	26	20
Cohort 2: Immediately Post-op (Day 0) COMPLETED	0	0	0	24	19
Cohort 2: Immediately Post-op (Day 0) NOT COMPLETED	0	0	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Placebo Matched Placebo administered 24 hours post-surgery (Day 1)	Cohort 1: CR845 0.008 mg/kg CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)	Cohort 1: CR845 0.024 mg/kg CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)	Cohort 2: Placebo Matched Placebo administered within 3 hours after surgery (Day 0)	Cohort 2: CR845 0.040 mg/kg CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours after surgery (Day 0)
Cohort 1: 24 Hours After Surgery (Day 1) Adverse Event	2	1	1	0	0
Cohort 1: 24 Hours After Surgery (Day 1) Lost to Follow-up	1	1	2	0	0
Cohort 1: 24 Hours After Surgery (Day 1) Withdrawal by Subject	0	3	0	0	0
Cohort 2: Immediately Post-op (Day 0) Protocol Violation	0	0	0	1	0
Cohort 2: Immediately Post-op (Day 0) Lost to Follow-up	0	0	0	1	1

Baseline Characteristics

Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Placebo n=25 Participants Matched placebo administered 24 hours post-surgery (Day 1)	Cohort 1: CR845 0.008 mg/kg n=22 Participants CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)	Cohort 1: CR845 0.024 mg/kg n=21 Participants CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)	Cohort 2: Placebo n=26 Participants Matched placebo administered within 3 hours post-surgery (Day 0)	Cohort 2: CR845 0.040 mg/kg n=20 Participants CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours post-surgery (Day 0)	Total n=114 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=39 Participants	22 Participants n=41 Participants	21 Participants n=35 Participants	26 Participants n=31 Participants	20 Participants n=146 Participants	114 Participants n=19 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Sex: Female, Male Female	25 Participants n=39 Participants	22 Participants n=41 Participants	21 Participants n=35 Participants	26 Participants n=31 Participants	20 Participants n=146 Participants	114 Participants n=19 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants	0 Participants n=19 Participants
Region of Enrollment United States	25 participants n=39 Participants	22 participants n=41 Participants	21 participants n=35 Participants	26 participants n=31 Participants	20 participants n=146 Participants	114 participants n=19 Participants

PRIMARY outcome

Timeframe: 15 and 30 minutes after study drug administration

Population: Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population.

Outcome measures

Outcome measures
Measure	Cohort 2: Placebo n=26 Participants Cohort 2: Matched Placebo administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.	Cohort 2: CR845 0.040 mg/kg n=20 Participants Cohort 2: CR845 (0.040 mg/kg) administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
Responders on Pain Intensity(PI) and Pain Relief (PR) Composite Endpoint	1 responders	1 responders

SECONDARY outcome

Timeframe: 0 to 16 hours

Population: Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population.

Outcome measures

Outcome measures
Measure	Cohort 2: Placebo n=25 Participants Cohort 2: Matched Placebo administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.	Cohort 2: CR845 0.040 mg/kg n=20 Participants Cohort 2: CR845 (0.040 mg/kg) administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
Total PCA Morphine Consumption in the 0-16 Hour Period Following Postoperative Study Drug Treatment	24.0 mg Standard Deviation 15.4	15.8 mg Standard Deviation 11.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 to 8 hours

Population: Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population, based on the number of evaluable patients over the 4-8 hour time interval.

Outcome measures

Outcome measures
Measure	Cohort 2: Placebo n=23 Participants Cohort 2: Matched Placebo administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.	Cohort 2: CR845 0.040 mg/kg n=19 Participants Cohort 2: CR845 (0.040 mg/kg) administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
Total PCA Morphine Consumption in the 4-8 Hour Period Following Postoperative Study Drug Treatment	5.9 mg Standard Deviation 4.56	2.9 mg Standard Deviation 2.63

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 to 16 hours

Population: Results are for Cohort 2 (study drug administered within 3 hours after surgery), ITT population, based on the number of evaluable patients over the 8-16 hour time interval.

Outcome measures

Outcome measures
Measure	Cohort 2: Placebo n=22 Participants Cohort 2: Matched Placebo administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.	Cohort 2: CR845 0.040 mg/kg n=19 Participants Cohort 2: CR845 (0.040 mg/kg) administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
Total PCA Morphine Consumption in the 8-16 Hour Period Following Postoperative Study Drug Treatment	6.5 mg Standard Deviation 5.28	13.8 mg Standard Deviation 11.5

Adverse Events

Cohort 1: Placebo

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Cohort 1: CR845 0.008 mg/kg

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Cohort 1: CR845 0.024 mg/kg

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

Cohort 2: Placebo

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Cohort 2: CR845 0.040 mg/kg

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Placebo n=25 participants at risk Matched placebo administered 24 hours after surgery (Day 1)	Cohort 1: CR845 0.008 mg/kg n=22 participants at risk CR845 (0.008 mg/kg) administered 24 hours after surgery (Day 1)	Cohort 1: CR845 0.024 mg/kg n=21 participants at risk CR845 (0.024 mg/kg) administered 24 hours after surgery (Day 1)	Cohort 2: Placebo n=26 participants at risk Matched Placebo administered within 3 hours after surgery (Day 0)	Cohort 2: CR845 0.040 mg/kg n=20 participants at risk Cohort 2: CR845 (0.040 mg/kg) administered within 3 hours after surgery (Day 0)
Infections and infestations Pneumonia	4.0% 1/25 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/21 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/26 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/20 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Gastrointestinal disorders Peritoneal Hemorrhage	4.0% 1/25 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/21 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/26 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/20 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	4.0% 1/25 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/21 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/26 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/20 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Nervous system disorders Cerebral Infarction	0.00% 0/25 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	4.5% 1/22 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/21 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/26 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/20 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Infections and infestations Pelvic Abscess	0.00% 0/25 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/26 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/20 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Gastrointestinal disorders Gastrointestinal Inflammation	0.00% 0/25 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/26 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/20 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/25 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/21 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/26 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	5.0% 1/20 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Injury, poisoning and procedural complications Postoperative Ileus	0.00% 0/25 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/21 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/26 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	5.0% 1/20 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Nervous system disorders Sedation	0.00% 0/25 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/21 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/26 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	5.0% 1/20 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
General disorders Pyrexia	0.00% 0/25 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/21 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/20 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.

Other adverse events

Other adverse events
Measure	Cohort 1: Placebo n=25 participants at risk Matched placebo administered 24 hours after surgery (Day 1)	Cohort 1: CR845 0.008 mg/kg n=22 participants at risk CR845 (0.008 mg/kg) administered 24 hours after surgery (Day 1)	Cohort 1: CR845 0.024 mg/kg n=21 participants at risk CR845 (0.024 mg/kg) administered 24 hours after surgery (Day 1)	Cohort 2: Placebo n=26 participants at risk Matched Placebo administered within 3 hours after surgery (Day 0)	Cohort 2: CR845 0.040 mg/kg n=20 participants at risk Cohort 2: CR845 (0.040 mg/kg) administered within 3 hours after surgery (Day 0)
Gastrointestinal disorders Constipation	8.0% 2/25 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	15.0% 3/20 • Number of events 3 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Gastrointestinal disorders Flatulence	12.0% 3/25 • Number of events 3 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	9.1% 2/22 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	9.5% 2/21 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	15.4% 4/26 • Number of events 4 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	20.0% 4/20 • Number of events 4 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Gastrointestinal disorders Nausea	8.0% 2/25 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	13.6% 3/22 • Number of events 3 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/21 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	53.8% 14/26 • Number of events 14 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	15.0% 3/20 • Number of events 3 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
General disorders Pyrexia	12.0% 3/25 • Number of events 3 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	4.5% 1/22 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	14.3% 3/21 • Number of events 3 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	5.0% 1/20 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Infections and infestations Urinary Tract Infection	8.0% 2/25 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	4.5% 1/22 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	9.5% 2/21 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	7.7% 2/26 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	20.0% 4/20 • Number of events 4 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Musculoskeletal and connective tissue disorders Musculoskeletal	8.0% 2/25 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	4.5% 1/22 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/26 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/20 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Nervous system disorders Dizziness	8.0% 2/25 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	14.3% 3/21 • Number of events 3 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	15.0% 3/20 • Number of events 3 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Nervous system disorders Headache	16.0% 4/25 • Number of events 4 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	22.7% 5/22 • Number of events 5 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	19.0% 4/21 • Number of events 4 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/26 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/20 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Nervous system disorders Paraesthesia	0.00% 0/25 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	18.2% 4/22 • Number of events 4 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	28.6% 6/21 • Number of events 6 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/26 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/20 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Renal and urinary disorders Urinary Retention	8.0% 2/25 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/21 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	20.0% 4/20 • Number of events 4 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/25 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	9.1% 2/22 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	19.2% 5/26 • Number of events 5 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	5.0% 1/20 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Gastrointestinal disorders Vomiting	4.0% 1/25 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	4.8% 1/21 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	11.5% 3/26 • Number of events 3 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/20 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.0% 1/25 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	4.5% 1/22 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/21 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	10.0% 2/20 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.
Vascular disorders Hypotension	0.00% 0/25 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/22 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	0.00% 0/21 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	3.8% 1/26 • Number of events 1 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.	10.0% 2/20 • Number of events 2 • Treatment-emergent adverse events were collected from the time the patient received her first dose of study drug through the Follow-up Visit.

Additional Information

Frédérique Menzaghi, PhD, Vice President Research & Development

Cara Therapeutics Inc.

Phone: 203-567-1502

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60