PainEarly Phase 1LoperamideNCT02711891
Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing
A Early Phase 1 study testing Loperamide in people with Pain, run by Rush University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Loperamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2015
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers willing to have 2 consecutive finger sticks completed.
Who cannot join
- 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.
About this study
Official title: Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing: A Randomized Double Blind Trial
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.
Read the detailed description
Lancing the finger and heel to obtain capillary blood for specimen collection and diagnostic testing is a painful and tissue damaging procedure. With each lance, there is direct splicing of capillaries along with free nerve endings resulting in an immediate localized pain response and hyperalgesia from the release of pain producing substances. Opioid agonists (morphine, fentanyl, loperamide) have demonstrated significant analgesia when locally injected or topically applied to a site of inflammation/injury in animal models.
Loperamide, a piperdine derivative with a structure similar to the synthetic opioid meperidine, has strong affinity for Mu opioid receptors. It was approved by the FDA in 1969 as an anti-diarrheal agent with Mu opioid activity mimicked the constipating effects of other opioids, but with markedly reduced CNS effects due to its affinity for p-glycoprotein, preventing crossing the blood brain barrier (BBB) under normal circumstances.
This prospective, double-blind, repeated measures, randomized investigational new drug trial used loperamide developed as a topical gel in 34 adult participants to determine its analgesic effects during repeat finger lancing. The investigators also assessed for any local skin reaction to the gel application and for any constipation or abdominal cramping which might be evidence of systemic absorption and Mu opioid agonist activity on the gut.
This study would be applicable for use in 28.9 million adults who are diabetic and require finger lancing for blood glucose monitoring and the high risk newborn population who require repeat heel lancing for specimen collection.
- Conditions
- Pain
- Being tested
- Loperamide, Drug, placebo gel
- Keywords
- fingerstick, opioid, heelstick, loperamide, topical opioid
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoperamideDrug
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, placebo gelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 5% Loperamide gel | Experimental | 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. 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 loperamide gel which was left in place for 30 minutes. The placebo gel contained the same ingredients without the loperamide. The loperamide gel formulation includes: Loperamide 5%, Propylene Glycol; Ethanol (190 proof USP); Ethyl acetate; and Klucel HF 1%. Receives: Drug: Loperamide |
| Placebo gel | Placebo comparator | 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%. Receives: Drug: Drug, placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - Numeric Rating Scale
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.
Measured: Within one minute following each lance
Pain - Comparative Pain Scale
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.
Measured: 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.
Secondary outcomes (5)
24 Hour Numeric Pain (0 to 10 Scale) in the Lanced Finger Site.
Numeric pain rating using the numeric rating scale 0-10 (0=no pain and 10 = worst pain ever) at 24 hours following finger lancing
Measured: 24 hours following the second lance.
24 Hour Sensitivity in Lanced Finger to Touch and Pressure
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.
Measured: 24 hours post lancing.
Change in Beats Per Minute (BPM) Within Groups During Lance One and Lance Two Procedure
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.
Measured: Average of BPM during each phase of the lance procedure (lance, specimen collection, recovery)
Safety- Number of Participants With Treatment Related Adverse Events as Assessed by the CTCAE V.4
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.
Measured: Direct observation of treatment site at one minute and 30 minutes. Participant report at 24 hours if any redness is present on the forearm.
Safety - Number of Participants With Treatment Related Adverse Gastrointestinal Disorders Using the CTCAE V. 4 With Focus on Abdominal Pain, Constipation and Diarrhea
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..
Measured: 24 hour participant report
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711891
- Sponsor's protocol ID
- 13091401-IRB02
- Other IDs
- IND 122919
- Acronym
- Loperamide
- Status last verified
- Apr 2024
- First submitted
- 11 Dec 2015
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Owens ME, Todt EH. Pain in infancy: neonatal reaction to a heel lance. Pain. 1984 Sep;20(1):77-86. doi: 10.1016/0304-3959(84)90813-3.
PubMed 6493791Fruhstorfer H, Schmelzeisen-Redeker G, Weiss T. Capillary blood volume and pain intensity depend on lancet penetration. Diabetes Care. 2000 Apr;23(4):562-3. doi: 10.2337/diacare.23.4.562. No abstract available.
PubMed 10857956Johnston CC, Strada ME. Acute pain response in infants: a multidimensional description. Pain. 1986 Mar;24(3):373-382. doi: 10.1016/0304-3959(86)90123-5.
PubMed 3960577Stein C. The control of pain in peripheral tissue by opioids. N Engl J Med. 1995 Jun 22;332(25):1685-90. doi: 10.1056/NEJM199506223322506. No abstract available.
PubMed 7760870Stein C, Schafer M, Machelska H. Attacking pain at its source: new perspectives on opioids. Nat Med. 2003 Aug;9(8):1003-8. doi: 10.1038/nm908.
PubMed 12894165DeHaven-Hudkins DL, Burgos LC, Cassel JA, Daubert JD, DeHaven RN, Mansson E, Nagasaka H, Yu G, Yaksh T. Loperamide (ADL 2-1294), an opioid antihyperalgesic agent with peripheral selectivity. J Pharmacol Exp Ther. 1999 Apr;289(1):494-502.
PubMed 10087042Nozaki-Taguchi N, Yaksh TL. Characterization of the antihyperalgesic action of a novel peripheral mu-opioid receptor agonist--loperamide. Anesthesiology. 1999 Jan;90(1):225-34. doi: 10.1097/00000542-199901000-00029.
PubMed 9915332Page GG. Are there long-term consequences of pain in newborn or very young infants? J Perinat Educ. 2004 Summer;13(3):10-7. doi: 10.1624/105812404X1725.
PubMed 17273395Osborne DW. (2002). Patent No. US 6355657 B1. US. https://www.google.com/patents/US6355657 Accessed June 1, 2014
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Loperamide Gel for Pain Reduction During Repeat Finger Lancing: A Randomized Double Blind Trial
- ClinicalTrials.gov ID
- NCT02711891
- Acronym / sponsor ID
- Loperamide / 13091401-IRB02
- Conditions
- Pain
- Keywords
- fingerstick, opioid, heelstick, loperamide, topical opioid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lancing the finger and heel to obtain capillary blood for specimen collection and diagnostic testing is a painful and tissue damaging procedure. With each lance, there is direct splicing of capillaries along with free nerve endings resulting in an immediate localized pain response and hyperalgesia from the release of pain producing substances. Opioid agonists (morphine, fentanyl, loperamide) have demonstrated significant analgesia when locally injected or topically applied to a site of inflammation/injury in animal models.
Loperamide, a piperdine derivative with a structure similar to the synthetic opioid meperidine, has strong affinity for Mu opioid receptors. It was approved by the FDA in 1969 as an anti-diarrheal agent with Mu opioid activity mimicked the constipating effects of other opioids, but with markedly reduced CNS effects due to its affinity for p-glycoprotein, preventing crossing the blood brain barrier (BBB) under normal circumstances.
This prospective, double-blind, repeated measures, randomized investigational new drug trial used loperamide developed as a topical gel in 34 adult participants to determine its analgesic effects during repeat finger lancing. The investigators also assessed for any local skin reaction to the gel application and for any constipation or abdominal cramping which might be evidence of systemic absorption and Mu opioid agonist activity on the gut.
This study would be applicable for use in 28.9 million adults who are diabetic and require finger lancing for blood glucose monitoring and the high risk newborn population who require repeat heel lancing for specimen collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% Loperamide gel | Experimental | Drug: LoperamideParticipants 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. 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 loperamide gel which was left in place for 30 minutes. The placebo gel contained the same ingredients without the loperamide. The loperamide gel formulation includes: Loperamide 5%, Propylene Glycol; Ethanol (190 proof USP); Ethyl acetate; and Klucel HF 1%. |
| Placebo gel | Placebo comparator | Drug: Drug, placebo gelParticipants 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%. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers willing to have 2 consecutive finger sticks completed.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LoperamideFollowing 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 | 5% Loperamide gel |
| Drug, placebo gelFollowing 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. | Drug | Placebo gel |
Primary outcome
Pain - Numeric Rating Scale
Time frame: 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.
Pain - Comparative Pain Scale
Time frame: 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.
5 secondary outcomes
24 Hour Numeric Pain (0 to 10 Scale) in the Lanced Finger Site.
Time frame: 24 hours following the second lance.
24 Hour Sensitivity in Lanced Finger to Touch and Pressure
Time frame: 24 hours post lancing.
Change in Beats Per Minute (BPM) Within Groups During Lance One and Lance Two Procedure
Time frame: Average of BPM during each phase of the lance procedure (lance, specimen collection, recovery)
Safety- Number of Participants With Treatment Related Adverse Events as Assessed by the CTCAE V.4
Time frame: Direct observation of treatment site at one minute and 30 minutes. Participant report at 24 hours if any redness is present on the forearm.
Safety - Number of Participants With Treatment Related Adverse Gastrointestinal Disorders Using the CTCAE V. 4 With Focus on Abdominal Pain, Constipation and Diarrhea
Time frame: 24 hour participant report
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6493791Owens ME, Todt EH. Pain in infancy: neonatal reaction to a heel lance. Pain. 1984 Sep;20(1):77-86. doi: 10.1016/0304-3959(84)90813-3.
- Background: PubMed 10857956Fruhstorfer H, Schmelzeisen-Redeker G, Weiss T. Capillary blood volume and pain intensity depend on lancet penetration. Diabetes Care. 2000 Apr;23(4):562-3. doi: 10.2337/diacare.23.4.562. No abstract available.
- Background: PubMed 3960577Johnston CC, Strada ME. Acute pain response in infants: a multidimensional description. Pain. 1986 Mar;24(3):373-382. doi: 10.1016/0304-3959(86)90123-5.
- Background: PubMed 7760870Stein C. The control of pain in peripheral tissue by opioids. N Engl J Med. 1995 Jun 22;332(25):1685-90. doi: 10.1056/NEJM199506223322506. No abstract available.
- Background: PubMed 12894165Stein C, Schafer M, Machelska H. Attacking pain at its source: new perspectives on opioids. Nat Med. 2003 Aug;9(8):1003-8. doi: 10.1038/nm908.
- Background: PubMed 10087042DeHaven-Hudkins DL, Burgos LC, Cassel JA, Daubert JD, DeHaven RN, Mansson E, Nagasaka H, Yu G, Yaksh T. Loperamide (ADL 2-1294), an opioid antihyperalgesic agent with peripheral selectivity. J Pharmacol Exp Ther. 1999 Apr;289(1):494-502.
- Background: PubMed 9915332Nozaki-Taguchi N, Yaksh TL. Characterization of the antihyperalgesic action of a novel peripheral mu-opioid receptor agonist--loperamide. Anesthesiology. 1999 Jan;90(1):225-34. doi: 10.1097/00000542-199901000-00029.
- Background: PubMed 17273395Page GG. Are there long-term consequences of pain in newborn or very young infants? J Perinat Educ. 2004 Summer;13(3):10-7. doi: 10.1624/105812404X1725.
- BackgroundOsborne DW. (2002). Patent No. US 6355657 B1. US. https://www.google.com/patents/US6355657 Accessed June 1, 2014
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Loperamide in people with Pain, run by Rush University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain - Numeric Rating Scale (time frame: Within one minute following each lance). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02711891, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.