Trial Outcomes & Findings for Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing (NCT NCT02711891)

Results Overview

Subject responded to "Please mark the degree of pain you felt following the lance" and drew a line on a 0 (no pain) to 10 (worst possible pain) scale within one minute of the lance.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

34 participants

Primary outcome timeframe

Within one minute following each lance

Results posted on

2024-09-19

Participant Flow

Individuals were excluded from participating if they had a history of drug induced hypersensitivity reactions; took any anti-inflammatory medications in the past 12 hours; if they routinely performed finger lancing for blood specimen monitoring (e.g. diabetes); or had calloused fingers pads.

Participant milestones

Participant milestones
Measure	5% Loperamide Gel Participants received 5% loperamide gel (0.2gm equivalent to 10 mg) applied following a single surgilance to the 5th digit. The loperamide gel was applied 10 minutes following the first lance, rubbed in for one minute within an 8 mm mold surrounding the lance site and then 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 forearm was also swabbed with the loperamide gel which was left in place for 30 minutes. The loperamide gel formulation includes: Loperamide 5%, Propylene Glycol; Ethanol (190 proof USP); Ethyl acetate; and Klucel HF 1%.	Placebo Gel Participants received placebo gel (0.2gm) applied following a single surgilance to the 5th digit. The placebo gel was applied 10 minutes following the first lance, rubbed in for one minute within an 8 mm mold surrounding the lance site. The mold was removed and the gel was covered with a transparent occlusive dressing and left in place for 30 minutes. The forearm was also swabbed with the placebo gel which was left in place for 30 minutes. .The placebo gel contained the same ingredients without the loperamide. The placebo gel formulation includes: Propylene Glycol; Ethanol (190 proof USP); Ethyl acetate; and Klucel HF 1%.
Overall Study STARTED	17	17
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5% Loperamide Gel n=17 Participants 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.	Placebo Gel n=17 Participants 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.	Total n=34 Participants Total of all reporting groups
Age, Continuous	42 years n=99 Participants	39 years n=107 Participants	41.5 years n=206 Participants
Sex: Female, Male Female	12 Participants n=99 Participants	12 Participants n=107 Participants	24 Participants n=206 Participants
Sex: Female, Male Male	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants
Region of Enrollment United States	17 participants n=99 Participants	17 participants n=107 Participants	34 participants n=206 Participants
Anxiety to needle stick scale	2.8 units on a scale STANDARD_DEVIATION 2.6 • n=99 Participants	3.2 units on a scale STANDARD_DEVIATION 2.6 • n=107 Participants	2.9 units on a scale STANDARD_DEVIATION 2.5 • n=206 Participants

PRIMARY outcome

Timeframe: Within one minute following each lance

Subject responded to "Please mark the degree of pain you felt following the lance" and drew a line on a 0 (no pain) to 10 (worst possible pain) scale within one minute of the lance.

Outcome measures

Outcome measures
Measure	Pain Rating Loperamide Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Loperamide 5% gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.	Pain Rating Placebo Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Placebo gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.
Pain - Numeric Rating Scale Lance 2	1.9 units on a scale Standard Deviation 1.4	4.2 units on a scale Standard Deviation 2.4
Pain - Numeric Rating Scale Basal Lance	2.6 units on a scale Standard Deviation 1.7	2.5 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: Within one minute of the second lance, participants will be asked to circle their comparison pain rating to the first lance delivered 40 minutes earlier to the same digit.

Within one minute following the second lance, subjects were asked "In comparison to the first finger stick, how would you rate the pain of the second": much less, a little less, about the same, a little more or much more.

Outcome measures

Outcome measures
Measure	Pain Rating Loperamide Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Loperamide 5% gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.	Pain Rating Placebo Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Placebo gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.
Pain - Comparative Pain Scale Participants rating pain much less	3 Participants	0 Participants
Pain - Comparative Pain Scale Participants rating pain a little less	5 Participants	0 Participants
Pain - Comparative Pain Scale Participants rating pain a little more	1 Participants	4 Participants
Pain - Comparative Pain Scale Participants rating pain much more	1 Participants	4 Participants
Pain - Comparative Pain Scale Participants rating pain about the same	7 Participants	9 Participants

SECONDARY outcome

Timeframe: 24 hours following the second lance.

Numeric pain rating using the numeric rating scale 0-10 (0=no pain and 10 = worst pain ever) at 24 hours following finger lancing

Outcome measures

Outcome measures
Measure	Pain Rating Loperamide Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Loperamide 5% gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.	Pain Rating Placebo Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Placebo gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.
24 Hour Numeric Pain (0 to 10 Scale) in the Lanced Finger Site.	.23 score on a scale Standard Deviation .56	1.23 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 24 hours post lancing.

Population: 17 participants from both groups/arms were analyzed for this result outcome based on the score on the scale.

Sensitivity questions adapted from the pain quality assessment scale: After the application of the gel in both the treatment and control (Placebo) group, each participant from both groups was asked about the sensitivity of the fingerstick site to light or clothing rubbing against it over the past day (24 hours later), the sensitivity scale is as follows: (0=non-sensitive; 1-sensitive). A scale score of 0 means- a better outcome. After the application of the gel in both the treatment and control (Placebo) group, each participant from both groups was asked about the sensitivity of the fingerstick site when something was pressed against it over the past day (24 hours later), the sensitivity scale is as follows: (0=not tender and 1=tender). A scale score of 0 means- a better outcome.

Outcome measures

Outcome measures
Measure	Pain Rating Loperamide Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Loperamide 5% gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.	Pain Rating Placebo Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Placebo gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.
24 Hour Sensitivity in Lanced Finger to Touch and Pressure Proportion of participants with no sensitivity	14 Participants	6 Participants
24 Hour Sensitivity in Lanced Finger to Touch and Pressure Proportion with no sensitivity to pressure	15 Participants	5 Participants

SECONDARY outcome

Timeframe: Average of BPM during each phase of the lance procedure (lance, specimen collection, recovery)

Population: Repeat measures lance one and lance two -

BPM obtained using the Kenek Edge Pulse Oximeter System using a flipclop sensor and companion app. Mean BPM during lance initiation through recovery (30 seconds following lance) reported.

Outcome measures

Outcome measures
Measure	Pain Rating Loperamide Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Loperamide 5% gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.	Pain Rating Placebo Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Placebo gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.
Change in Beats Per Minute (BPM) Within Groups During Lance One and Lance Two Procedure Lance One BPM Average	74.6 beats per minute (Mean) Standard Deviation 12.0	74.1 beats per minute (Mean) Standard Deviation 9.4
Change in Beats Per Minute (BPM) Within Groups During Lance One and Lance Two Procedure Lance 2 BPM Average	74.3 beats per minute (Mean) Standard Deviation 11.4	71.8 beats per minute (Mean) Standard Deviation 7.19

SECONDARY outcome

Timeframe: Direct observation of treatment site at one minute and 30 minutes. Participant report at 24 hours if any redness is present on the forearm.

CTCAE will be utilized for reporting any adverse events with specific focus on skin and tissue disorders. A Standard erythema scale (0=no effect, 0.5=observer indecisive, 1=faint pink-no border, 1.5=faint pink border, 2=faint pink with one border, 2.5=fain pink with two borders, 3=red, 3.5=fiery red 4=violaceous red will also be used to classify skin erythema.

Outcome measures

Outcome measures
Measure	Pain Rating Loperamide Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Loperamide 5% gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.	Pain Rating Placebo Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Placebo gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.
Safety- Number of Participants With Treatment Related Adverse Events as Assessed by the CTCAE V.4	0 participants	0 participants

SECONDARY outcome

Timeframe: 24 hour participant report

Participant report of any abdominal pain or change in stool pattern (constipation or diarrhea) over the past 24 hours using the CTCAE V.4 with focus on abdominal pain, constipation and diarrhea..

Outcome measures

Outcome measures
Measure	Pain Rating Loperamide Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Loperamide 5% gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.	Pain Rating Placebo Study Arm n=17 Participants The 5th digit finger pad of the non-dominant hand was cleaned with 70% alcohol. The participant was asked to look away and the finger pad was punctured using a single-use lancet which contains a stainless steel blade automatic trigger and retractor that incises with a 21 guage needle to a controlled depth of 2.2 mm and with of 0.8 mm. The pain rating was obtained within one minute following the lance. Ten minutes following lance one, 0.2 grams of Placebo gel was applied using a circular mold to the lance site and left in place for 30 minutes. At 30 minutes, the gel was removed, site cleansed with alcohol and lanced in the same location. The second pain rating was obtained within one minute of the lance.
Safety - Number of Participants With Treatment Related Adverse Gastrointestinal Disorders Using the CTCAE V. 4 With Focus on Abdominal Pain, Constipation and Diarrhea	0 participants	0 participants

Adverse Events

5% Loperamide Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen C. Heneghan, RN, PhD

Rush University Medical Center

Phone: 3123395943

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place