Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Pain
Interventions
DRUG

Loperamide

Following lance one, 0.2 grams of loperamide 5% gel was applied from a sterile syringe to the participants previous lance site within an 8 mm diameter circular plastic mold. The loperamide gel was rubbed lightly on the skin surface for one minute using a gloved finger swirled into the mold site. The mold was removed and the site was covered with a transparent occlusive dressing for 30 minutes. At 30 minutes the gel was removed with gauze, the skin cleaned with an alcohol wipe and the second lance was done within the same location as the first. The loperamide gel was also swabbed to the forearm within the 8 mm mold and left in place for 30 minutes.

DRUG

Drug, placebo gel

Following lance one, 0.2 grams of gel alone was applied to the participants previous lance site within an 8mm diameter circular plastic mold. The gel was rubbed lightly on the skin surface for one minute using a gloved finger swirled into the mold site. The mold was removed and the site was covered with a transparent occlusive dressing left in place for 30 minutes. At 30 minutes the gel was removed with gauze, the skin cleaned with an alcohol wipe and the second lance was done within the same location as the first. The placebo gel was also swabbed to the forearm within the 8 mm mold and left in place for 30 minutes.

All Listed Sponsors
lead

Rush University Medical Center

OTHER

NCT02711891 - Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing | Biotech Hunter | Biotech Hunter