Trial Outcomes & Findings for A Pilot Study at a Single-Institution of Pregabalin in the Management of Mucositis Pain in Patients Undergoing Chemoradiation Therapy to the Head and Neck. (NCT NCT02277548)

NCT ID: NCT02277548

Last Updated: 2019-11-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2019-11-21

Participant Flow

Participant milestones

Measure	Lyrica at 300 mg Per Day Lyrica 300 mg: Lyrica 300 mg per day	Placebo Placebo
Overall Study STARTED	9	11
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study at a Single-Institution of Pregabalin in the Management of Mucositis Pain in Patients Undergoing Chemoradiation Therapy to the Head and Neck.

Baseline characteristics by cohort

Measure	Lyrica at 300 mg Per Day n=9 Participants Lyrica 300 mg: Lyrica 300 mg per day	Placebo n=9 Participants Placebo	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	57.3 years STANDARD_DEVIATION 14.1 • n=5 Participants	56.3 years STANDARD_DEVIATION 10.5 • n=7 Participants	56.5 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	7 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Outcome measures

Measure	Lyrica at 300 mg Per Day n=9 Participants Lyrica 300 mg: Lyrica 300 mg per day	Placebo n=9 Participants Placebo
Average/Cumulative Opioid Dose	32.65306 mg Standard Deviation 49.74759	31.60714 mg Standard Deviation 58.5934

Adverse Events

Lyrica at 300 mg Per Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lyrica at 300 mg Per Day n=9 participants at risk Lyrica 300 mg: Lyrica 300 mg per day	Placebo n=9 participants at risk；n=11 participants at risk Placebo
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 • 18 months	9.1% 1/11 • Number of events 1 • 18 months
General disorders Elevated creatinine, changed to non-qualifying chemotherapy	0.00% 0/9 • 18 months	9.1% 1/11 • Number of events 1 • 18 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Erin McMenamin

University of Pennsylvania

Phone: 251-662-2428

Email: Erin.McMenamin@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place