Study of the Neurokinin-1 Receptor Antagonist VDP-737 in Subjects with Chronic Pruritus
- Conditions
- Chronic pruritusTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-001581-10-IE
- Lead Sponsor
- Tigercat Pharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 264
1. Males or females who are at least 18 years of age and no more than 65 years of age.
2. Willing and able to understand and sign informed consent.
3. Subjects must have pruritus of at least 6 weeks duration which is unresponsive or inadequately responsive to current therapies such as topical steroids or antihistamine therapy.
4. History of chronic pruritus that may be associated with inflammatory skin disease (such as stable atopic dermatitis, psoriasis, lichen planus, aestatotic dermatitis, prurigonodularis, lichen simplex chronicus, and pruritus of undetermined origin that underwent full work up) or may be independent of a primary skin disease pruritus .
5. Subject must have a baseline VAS pruritus score of at least 7, and must have a score of at least 7 on 2 or more of the last 3 available entries in the e-diary provided at Screening.
6. Female subjects must be of non-childbearing potential (ie, post-menopausal for at least 1 year, had a hysterectomy, or had a tubal ligation) or, if of childbearing potential, must have a confirmed negative urine pregnancy test prior to study treatment and be willing to use effective contraception for the duration of the trial. Effective contraception is defined as follows: oral/implant/injectable/ transdermal contraceptives, intrauterine device, condom with spermicide, or diaphragm with spermicide. Abstinence or partner’s vasectomy is acceptable if the female agrees to use effective contraception if she decides to discontinue abstinence or to have sexual intercourse with a non-vasectomized partner.
7. Judged to be in good health based upon the results of a physical examination, medical history, and safety laboratory tests.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Have any medical condition or disability that would interfere with the assessment of safety or efficacy in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.
2. Have a history of sensitivity to any components of the study material.
3. Are females of childbearing potential who are unwilling to use adequate contraception or who are breast feeding.
4. Have any chronic or acute medical condition that, in the opinion of the investigator, might interfere with the study results or place the subject at undue risk.
5. Have chronic renal disease, i.e., serum creatinine greater than 2 times the upper limit of normal.
6. Have chronic liver disease, i.e., AST or ALT greater than 2 times the upper limit of normal. Subjects with hepatitis B and C who have normal liver function may be enrolled.
7. Have a current malignancy (such as Hodgkin’s lymphoma, B or T cell lymphoma, or myeloma) or blood cell dyscrasia (eg, polycythemia ormyelofibrosis) that would lead to systemic chronic pruritus.
8. Subjects with untreated hyperthyroidism.
9. Have pruritus of psychogenicetiology (delusions of parasitosis, obsessive compulsive disorder and major depression) or neuropathic etiology (due to shingles, spinal cord injury or with neurologic deficit).
10. Have pruritus due to urticaria, drug allergy, or infection (such as pityriasisrosea or tinea or active human immunodeficiency virus [HIV]). Note: Subjects with HIV who have undetectable viral load, CD 4 counts >200 cells/cc, and stable retroviral therapy may enroll.
11. Are on medications known to cause pruritus, i.e. Erbitux®, opioids, cocaine, amphetamines, and angiotensin converting enzyme (ACE) inhibitors.
12. Have taken investigational medications within 30 days prior to Screening.
13. Are unwilling to discontinue specific pruritus medications for at least two weeks prior to initiation of study and throughout the study period.
14. Have a history (within the previous 1 month) of use of tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRI),serotonin-norepinephrine reuptake inhibitors (SNRIS),monoamine oxidase (MAO) inhibitors, opioids, immune-modulators (e.g. azathioprine, methotrexate, mycophenolatemofetil, cyclosporine A, antibodies), or neuroactive medications (e.g. pregabalin, gabapentin).
15. Have a history (within the previous 1 month) of use of sedatives or tranquilizers. Subjects must undergo an appropriate washout period from any sedatives or tranquilizers before enrolling in the study.
16. Received ultraviolet B (UVB) or psoralen + ultraviolet A (PUVA) treatment within 30 days prior to Screening.
17. Within in the past 12 months, have expressed suicidal ideation with some intent to act.
18. Started or changed medications, creams, or emollients including over-the-counter (OTC) preparations or bath oil treatment for relief of pruritus within 7 days prior to Screening.
19. Have any social or medical condition (e.g. alcoholism, drug dependency, psychotic state) that, in the investigator’s opinion, might interfere with the subject’s ability to comply with the requirements of the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to compare the efficacy and safety of VPD-737 tablets (at concentrations of 0.25 mg, 1 mg, or 5 mg) and placebo given once daily for 6 weeks for the treatment of chronic pruritus.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint will be the percent change in VAS from Baseline, comparing drug to placebo for each dose Group<br>;Timepoint(s) of evaluation of this end point: Sensitivity analysis of the primary endpoint (with the mixed model) may be prepared using the average of the twice daily VAS measurements, resulting in up to 42 VAS measurements for each subject. A further sensitivity analysis with the mixed model using averaging each subjects' weekly VAS values, resulting in up to 6 VAS measurements for each subject.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary endpoints will be Subject Global Assessment, Dermatology Life Quality Index (DLQI), photographs of lesions (for illustrative purposes only), Pittsburgh Insomnia Symptom Questionnaire (PSSQ_I), and the Physicians’ Global Assessment.<br>;Timepoint(s) of evaluation of this end point: The Subject Global Assessment, in which subjects will be asked In the past 24 hours, please describe your itching,” and their responses, rated as ‘none’, ‘mild’, ‘moderate’, or ‘severe’ will be summarized descriptively.<br>