Trial Outcomes & Findings for Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy (NCT NCT02169336)

Last Updated: 2015-12-10

Results Overview

Pain intensity was recorded using a Numeric Rating Scale (Range 0-10) where 0 equates to no pain, and 10 equates to the worst pain imaginable. Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours. Pain intensity differences from baseline at each time point were calculated and a time weighted SPID was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

95 participants

Primary outcome timeframe

48 hours

Results posted on

2015-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	DEX-IN 35mcg DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days. Intranasal Dexmedetomidine	DEX-IN 50mcg DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days. Intranasal Dexmedetomidine	IN Placebo IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days. Intranasal Placebo
Overall Study STARTED	31	32	32
Overall Study COMPLETED	27	28	29
Overall Study NOT COMPLETED	4	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	DEX-IN 35mcg DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days. Intranasal Dexmedetomidine	DEX-IN 50mcg DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days. Intranasal Dexmedetomidine	IN Placebo IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days. Intranasal Placebo
Overall Study Lack of Efficacy	1	1	0
Overall Study Adverse Event	2	3	1
Overall Study Withdrawal by Subject	1	0	0
Overall Study Physician Decision	0	0	1
Overall Study Subject declined to continue dosing	0	0	1

Baseline Characteristics

Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DEX-IN 35mcg n=31 Participants DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days. Intranasal Dexmedetomidine	DEX-IN 50mcg n=32 Participants DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days. Intranasal Dexmedetomidine	IN Placebo n=32 Participants IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days. Intranasal Placebo	Total n=95 Participants Total of all reporting groups
Age, Continuous	43.6 years STANDARD_DEVIATION 14.53 • n=5 Participants	44.6 years STANDARD_DEVIATION 12.21 • n=7 Participants	44.6 years STANDARD_DEVIATION 13.93 • n=5 Participants	44.2 years STANDARD_DEVIATION 13.44 • n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	28 Participants n=7 Participants	27 Participants n=5 Participants	78 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants	38 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	22 Participants n=7 Participants	18 Participants n=5 Participants	57 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	24 Participants n=7 Participants	21 Participants n=5 Participants	69 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	DEX-IN 35mcg n=31 Participants DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days. Intranasal Dexmedetomidine	DEX-IN 50mcg n=32 Participants DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days. Intranasal Dexmedetomidine	IN Placebo n=32 Participants IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days. Intranasal Placebo
Summed Pain Intensity Difference Over the First 48 Hours (SPID48).	36.871 units on a scale Standard Deviation 93.7979	44.719 units on a scale Standard Deviation 79.0590	51.227 units on a scale Standard Deviation 100.3288

Adverse Events

DEX-IN 35mcg

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

DEX-IN 50mcg

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

IN Placebo

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Randall Mack

Recro Pharma, Inc

Phone: 484-395-2400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Discussion and/or publication of data generated is not permitted without the prior written consent of the sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	DEX-IN 35mcg n=31 participants at risk DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days. Intranasal Dexmedetomidine	DEX-IN 50mcg n=32 participants at risk DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days. Intranasal Dexmedetomidine	IN Placebo n=32 participants at risk IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days. Intranasal Placebo
Gastrointestinal disorders Constipation	6.5% 2/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	6.2% 2/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	3.1% 1/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Gastrointestinal disorders Nausea	35.5% 11/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	25.0% 8/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	43.8% 14/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Gastrointestinal disorders Vomiting	12.9% 4/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	9.4% 3/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	18.8% 6/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
General disorders Fatigue	22.6% 7/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	18.8% 6/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	25.0% 8/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Investigations Blood Pressure Decreased	12.9% 4/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	18.8% 6/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	0.00% 0/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Nervous system disorders Disturbance in Attention	16.1% 5/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	12.5% 4/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	15.6% 5/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Nervous system disorders Dizziness	19.4% 6/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	9.4% 3/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	15.6% 5/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Nervous system disorders Headache	16.1% 5/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	6.2% 2/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	18.8% 6/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Nervous system disorders Somnolence	64.5% 20/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	53.1% 17/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	53.1% 17/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	6.2% 2/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	9.4% 3/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Respiratory, thoracic and mediastinal disorders Nasal Discomfort	6.5% 2/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	3.1% 1/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	0.00% 0/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Respiratory, thoracic and mediastinal disorders Nasal Dryness	3.2% 1/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	6.2% 2/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	0.00% 0/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Respiratory, thoracic and mediastinal disorders Nasal Inflammation	0.00% 0/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	6.2% 2/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	9.4% 3/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Skin and subcutaneous tissue disorders Pruritus	6.5% 2/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	9.4% 3/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	12.5% 4/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.
Vascular disorders Hypotension	3.2% 1/31 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	9.4% 3/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.	0.00% 0/32 • All AEs were to be recorded beginning after administration of study medication through the final follow-up assessment. In addition, if the investigator became aware of the occurrence of a SAE within 30 days of the last visit, the SAE was to be reported.