The purpose of this study is to demonstrate whether or not VPD-737, an NK1 receptor antagonist is safe and effective for treatment of prurigo nodularis versus placebo.
The sensation of itch is transmitted to the brain through the nervous system. Several chemicals are involved in transmitting this signal.This trial of VPD 737 is intended to treat this condition by blocking one of the chemicals involved in the transmission of the itch signal. This is an oral drug administered once daily It has been used in other trials and has shown to be safe at the doses used in this trial. The trial will involve once daily pills for 8 weeks. Subject will be asked to fill out questionnaires both electronically and on paper during the study period. Patients will also be monitored for safety and will have blood taken for testing and several points during the trial. Overall participation will last about 14 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
NK1 receptor antagonist
Placebo
Study Site 08
Bonn, Germany
Study Site 06
Dresden, Germany
Study Site 12
Düsseldorf, Germany
Average Visual Analog Scale at Baseline
At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average Visual Analog Scale (VAS) (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.
Time frame: At Baseline
Average Visual Analog Scale at Week 2
At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.
Time frame: At Week 2
Average Visual Analog Scale at Week 4
At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.
Time frame: At Week 4
Average Visual Analog Scale at Week 8
At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Average VAS (average itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.
Time frame: At Week 8
Number of Participants With Improvement in Pruritus as Reported on Verbal Rating Scale (VRS) - Pruritus
At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome.
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Study Site 02
Frankfurt, Germany
Study Site 09
Hamburg, Germany
Study Site 05
Heidelberg, Germany
Study Site 03
Kiel, Germany
Study Site 11
Leipzig, Germany
Study Site 04
Lübeck, Germany
Study Site 14
Mainz, Germany
...and 5 more locations
Time frame: At Baseline and Week 8
Number of Participants With Improvement in Burning as Reported on Verbal Rating Scale (VRS) - Burning
At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome.
Time frame: At Baseline and Week 8
Number of Participants With Improvement in Stinging as Reported on Verbal Rating Scale (VRS) - Stinging
At study visits, participants used the VRS to rate their skin sensations (pruritus, burning, and stinging) using a 5-point scale (0 = not present; 1 = mild present; 2 = moderately present; 3 = severely present; and 4 = very severely present). Higher scores indicated worse outcome.
Time frame: At Baseline and Week 8
Worst Visual Analog Scale (VAS)
At study visits, participants recorded a mark for pruritus severity on a 10-cm horizontal line. This thermometer-type scale was marked with ratings of "no itch" (0 cm) and worst imaginable itch" (10 cm). Worst VAS (worst itch over the past 24 hours) was recorded. Higher scores indicated worse outcome.
Time frame: At Baseline, Weeks 2, 4, and 8
Number of Participants With Improvement in Pruritus as Reported on Patient Global Assessment (PGA)
The PGA included a question: Did the pruritus improve during the treatment period (yes/no).
Time frame: At Weeks 2, 4, and 8
Numeric Rating Scale (NRS)
Numeric Rating Scale: Using the patient diary, participants rated the following using an 11-point NRS (0 = no itching; to 10 = worst itch imaginable): average itching over the past 24 hours (Average NRS). Higher scores indicated worse outcome.
Time frame: At Baseline, Weeks 2, 4, and 8
Dermatology Life Quality Index (DLQI)
At each visit, participants completed a DLQI questionnaire. The DLQI is a validated questionnaire consisting of 10 questions relating to the degree to which the participant's skin condition affected his/her daily activities. The DLQI questionnaire is designed for use in adults, i.e. participants over the age of 16. The scoring of each question is as follows: Very much: scored 3, A lot: scored 2, A little: scored 1, Not at all: scored 0, Not relevant: scored 0, Question 7, 'prevented work or studying': scored 3. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. Interpreting the DLQI Scores: 0 - 1: no effect at all on participant's life, 2 - 5: small effect on participant's life, 6 - 10: moderate effect on participant's life, 11 - 20: very large effect on participant's life, 21 - 30: extremely large effect on participant's life.
Time frame: At Baseline, Weeks 2, 4, and 8
Pruritus-specific Quality of Life (ItchyQoL)
At each visit, participants completed an ItchyQoL questionnaire. The ItchyQoL is a validated questionnaire consisting of 22 questions based on the concerns and issues pertinent to participants with pruritus. Items should be scored for the following answers: Never: 1, Rarely: 2, Sometimes: 3, Often: 4, All the time:5. Higher scores indicated worse outcome. Total Score is obtained by calculating the unweighted mean of all ItchyQoL questions.
Time frame: At Baseline, Weeks 2, 4, and 8
Patient Benefit Index, Version for Patients With Pruritus (PBI-P)
At Visits 2 and 5 (or Early termination) only, participants completed the standardized and validated PBI-P questionnaire. Prior to treatment, the first page of the questionnaire, the Patient Needs Questionnaire (PNQ), was administered to determine how different benefits of therapy were relevant for the individual participant. After treatment, using the Patient Benefit Questionnaire (PBQ), participants were asked to evaluate the extent to which the benefits they indicated were important to them were, in fact, realized. From all the items taken together, a weighted total benefit value was calculated, which represented the patient relevant therapy benefits. The mean score greater than 1 is considered to represent a clinically relevant improvement. The items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for "does/did not apply to me" = 5; and missing value = -9. Higher scores indicated better outcome.
Time frame: At Week 8 / End of Treatment
Number of Participants With Improvement in PN Lesions as Reported on Investigator Global Assessment (IGA)
Using the IGA, physicians rated change in PN lesions (if any) from +5 ("markedly improved") to -5 ("markedly worse"). Higher scores indicated better outcome.
Time frame: At Week 8
Number of Participants With Improvement on Prurigo Activity Score (PAS)
Using the PAS, physicians described, localized, counted, and measured PN lesions. One of the 7 items was: Activity Stage (Stage 0-4: 0 = 0%, 1 = 1-25%, 2 = 26-50%, 3 = 51-75%, 4 = \> 75%) a. Prurigo lesions with excoriations/crusts Participants with PAS activity stage (prurigo lesions with excoriations/crusts) is presented in the below table.
Time frame: At Day 1 and Week 8
Participants With Rescue Medication Usage
Rescue medications included cetirizine hydrochloride, desloratadine, levocetirizine, and loratadine.
Time frame: Pre-treatment, upto 8 Weeks
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, without any judgment about causality.
Time frame: From the time of informed consent (Screening) until the last study visit (follow-up phone call, Week 10)