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Trial record 18 of 135 for:    AMITRIPTYLINE

Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine

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ClinicalTrials.gov Identifier: NCT03096444
Recruitment Status : Terminated (Efficacy was not seen after interim analysis)
First Posted : March 30, 2017
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Gil Yosipovitch, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pruritus
Interventions Drug: Ketamine Hydrochloride
Drug: Amitriptyline Hydrochloride
Drug: Lidocaine Hydrochloride
Combination Product: Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride
Drug: Lipoderm Cream
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Topical KeAmLi Combo/Ketamine/Amitriptyline/Lidocaine/Vehicle
Hide Arm/Group Description

Each participant will receive topical cream treatments applied for 30 minutes to 5 separate 4 x 4 cm predefined skin areas on the ventral forearms.

The 5 topical treatments are:

Topical KeAmLi Combo: Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) Topical ketamine: 10% Topical amitriptyline: 5% Topical lidocaine: 5% Topical vehicle: PCCA Lipoderm cream

Period Title: Overall Study
Number of participants Number of units (4x4cm skin arm test area)
Started 13 65
Completed 13 65
Not Completed 0 0
Arm/Group Title Topical KeAmLi Combo/Ketamine/Amitriptyline/Lidocaine/Vehicle
Hide Arm/Group Description

Each participant will receive topical cream treatments applied for 30 minutes to 5 separate 4 x 4 cm predefined skin areas on the ventral forearms.

The 5 topical treatments are:

Topical KeAmLi Combo: Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) Topical ketamine: 10% Topical amitriptyline: 5% Topical lidocaine: 5% Topical vehicle: PCCA Lipoderm cream

Overall Number of Baseline Participants 13
Overall Number of Units Analyzed
Type of Units Analyzed: Arm skin test area
65
Hide Baseline Analysis Population Description
All subjects received 5 topical cream treatments
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
9
  69.2%
Male
4
  30.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Hispanic or Latino
5
  38.5%
Not Hispanic or Latino
8
  61.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
  23.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   7.7%
White
9
  69.2%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo).
Hide Description Peak itch intensity between the vehicle and 4 other active treatments (individual ketamine, amitriptyline, or lidocaine, and KeAmLi-combo). Itch intensity was measured on a 100mm scale visual analog scale for 10 minutes. 0 was weighted with "no itch" and 100 was weighted with "most itch imaginable".
Time Frame 10 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects received 5 topical cream treatments.
Arm/Group Title Topical KeAmLi Combo Topical Ketamine Topical Amitriptyline Topical Lidocaine Topical Vehicle
Hide Arm/Group Description:

Topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Ketamine Hydrochloride: 2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Amitriptyline Hydrochloride: 2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Lidocaine Hydrochloride: 2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical vehicle (PCCA Lipoderm) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Lipoderm Cream: 2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Overall Number of Participants Analyzed 13 13 13 13 13
Mean (Standard Deviation)
Unit of Measure: Intensity score
62.7  (29.00397851) 63.1  (30.11218341) 69.2  (29.52725816) 65.8  (33.80866222) 61.9  (33.95207784)
2.Secondary Outcome
Title Thermal Threshold Detection (Warmth and Heat Pain)
Hide Description Two standardized quantitative sensory tests are performed to measure warmth detection threshold (assesses the threshold of which warmth sensation is first detected) and heat pain threshold (assesses the threshold at which heat pain sensation is first detected). Measured in change in celsius.
Time Frame 3 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects received treatment with the 5 topical cream formulations. Quantitative sensory testing was performed on each area of treated skin.
Arm/Group Title Topical KeAmLi Combo Topical Ketamine Topical Amitriptyline Topical Lidocaine Topical Vehicle
Hide Arm/Group Description:

Topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Ketamine Hydrochloride: 2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Amitriptyline Hydrochloride: 2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Lidocaine Hydrochloride: 2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical vehicle (PCCA Lipoderm) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Lipoderm Cream: 2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Overall Number of Participants Analyzed 13 13 13 13 13
Mean (Standard Deviation)
Unit of Measure: Degrees celsius
Warm Detection Threshold 33.6  (0.303939003) 34.0  (1.10853976) 33.9  (0.649150223) 33.7  (0.389004867) 33.8  (0.577436619)
Heat Pain Threshold 39.8  (2.401845207) 40.0  (2.2098072) 40.0  (2.80388162) 39.4  (2.305045253) 39.7  (2.227588606)
3.Secondary Outcome
Title Mechanical Thresholds (Mechanical Detection and Pain).
Hide Description Assess mechanical detection and pain thresholds using von Frey filaments stimulators (measured in force mN) to calculate the final threshold as the geometric mean of five series of ascending and descending stimuli.
Time Frame 5 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects received treatment with the 5 topical cream formulations. Quantitative sensory testing was performed on each area of treated skin.
Arm/Group Title Topical KeAmLi Combo Topical Ketamine Topical Amitriptyline Topical Lidocaine Topical Vehicle
Hide Arm/Group Description:

Topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Ketamine Hydrochloride: 2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Amitriptyline Hydrochloride: 2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Lidocaine Hydrochloride: 2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical vehicle (PCCA Lipoderm) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Lipoderm Cream: 2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Overall Number of Participants Analyzed 13 13 13 13 13
Mean (Standard Deviation)
Unit of Measure: mN
Mechanical Detection Threshold 3.519376956  (0.122225324) 3.464204768  (0.16205246) 3.573423965  (0.141531726) 3.546037659  (0.157416303) 3.525692637  (0.169487169)
Mechanical Pain Threshold 152.3293608  (90.32609423) 135.9  (121.5234567) 152.4768146  (114.1149716) 126.9  (106.9414678) 148.7138273  (104.3418768)
Time Frame Data was collect for 1 week from the time of treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topical KeAmLi Combo Topical Ketamine Topical Amitriptyline Topical Lidocaine Topical Vehicle
Hide Arm/Group Description

Topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride: 2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical ketamine 10% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Ketamine Hydrochloride: 2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical amitriptyline 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Amitriptyline Hydrochloride: 2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical lidocaine 5% will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Lidocaine Hydrochloride: 2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

Topical vehicle (PCCA Lipoderm) will be applied to one four 4 x 4 cm predefined skin areas on the ventral forearms during one of two study visits. The pre-treatment will occur under topical occlusion for 30 minutes to allow the ointment to be adsorbed. Following this, residual ointment will be removed and sensory testing, strictly within the pretreated area, will commence.

Lipoderm Cream: 2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.

All-Cause Mortality
Topical KeAmLi Combo Topical Ketamine Topical Amitriptyline Topical Lidocaine Topical Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Topical KeAmLi Combo Topical Ketamine Topical Amitriptyline Topical Lidocaine Topical Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Topical KeAmLi Combo Topical Ketamine Topical Amitriptyline Topical Lidocaine Topical Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%)   0/13 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Leigh Nattkemper
Organization: University of Miami
Phone: 3055889734
EMail: Lxn202@med.miami.edu
Publications:
Layout table for additonal information
Responsible Party: Gil Yosipovitch, University of Miami
ClinicalTrials.gov Identifier: NCT03096444     History of Changes
Other Study ID Numbers: 20170087
First Submitted: March 16, 2017
First Posted: March 30, 2017
Results First Submitted: February 19, 2019
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019