Early Phase 1
N=34
Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02711891 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Pain - Numeric Rating Scale — 2.6; 2.5; 1.9; 4.2 units on a scale — p=0.8
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Loperamide (Drug); Drug, placebo gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain - Numeric Rating Scale |
2.6; 2.5; 1.9; 4.2 | 0.8 |
| PRIMARY Pain - Comparative Pain Scale |
3; 0; 5; 0; 1; 4 | — |
| SECONDARY 24 Hour Numeric Pain (0 to 10 Scale) in the Lanced Finger Site. |
.23; 1.23 | 0.01 sig |
| SECONDARY 24 Hour Sensitivity in Lanced Finger to Touch and Pressure |
14; 6; 15; 5 | — |
| SECONDARY Change in Beats Per Minute (BPM) Within Groups During Lance One and Lance Two Procedure |
74.6; 74.1; 74.3; 71.8 | .876 |
| SECONDARY Safety- Number of Participants With Treatment Related Adverse Events as Assessed by the CTCAE V.4 |
0; 0 | — |
| SECONDARY Safety - Number of Participants With Treatment Related Adverse Gastrointestinal Disorders Using the CTCAE V. 4 With Focus on Abdominal Pain, Constipation and Diarrhea |
0; 0 | — |
Summary
This study evaluates topical loperamide 5% gel in reducing pain during repeat finger lancing (finger stick) in healthy adults. Half of participants received 5% loperamide gel applied to their fingertip prior to their second lance and the other half received the gel only.
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers willing to have 2 consecutive finger sticks completed.
Exclusion Criteria
- Participants are excluded if they have 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.
Data sourced from ClinicalTrials.gov (NCT02711891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.