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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03751111
Other study ID # 2018/NAL/CSU/PRU
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date February 13, 2019
Est. completion date March 30, 2019

Study information

Verified date April 2019
Source Xiangya Hospital of Central South University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of sublingual naloxone in the treatment of chronic itch in patients under arsenic exposure.


Description:

This study aims to determine the efficacy and safety of sublingual naloxone in the treatment of chronic, refractory itch in patients under long-term arsenic exposure. In this study, 200 subjects with a moderate-to-severe symptom of itching (numeric rating scale, NRS≥3) will be recruited and randomly treated with either sublingual naloxone (100 subjects) or placebo (100 subjects). The severity of itching will be evaluated in the wash out phase, baseline, and one week after the treatment through reporting of subjective symptomatology (itch NRS) via the interview. Quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI) and Dermatology Life Quality Index (DLQI) will serve as the secondary outcome.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 30, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Aged 18 years or over and without diseases except arsenic-related pruritus

2. Ability to study protocol and to give informed consent by himself/herself voluntarily

3. The number of male or female subjects is required more than 1/3 of the total number of subjects

4. Hair arsenic concentration=1 µg/g

5. Numeric Rating Sscale=3 at the baseline

6. Subjects taking hormone-containing medications must be on a stable dose for 6 months prior to study start to avoid any confounding influence on sensory and pain perception

Exclusion Criteria:

1. Use of oral anti-inflammatory medications for 2 weeks prior to the study start.

2. Use of oral anti-histamines for 2 weeks prior to the study start.

3. Use of topical or oral anti-pruritic agents for 2 weeks prior to the study start.

4. Use of oral neuromodulatory agents for 2 months prior to study start.

5. Current use of chronic pain medications (including opioids, antidepressants and anti-epileptic drugs).

6. Use of nicotine-containing products for the past 6 months prior to study start.

7. History of basic itchy dermatological diseases before such as eczema wich may influence the judgement of drug efficacy.

8. Unstable thyroid function within the past 6 months prior to study start to exclude thyroid-related neuropathy.

9. Known history of central or peripheral nervous system dysfunction.

10. History of acute hepatitis, chronic liver disease or end stage liver disease.

11. History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.

12. History of neuropathy associated with chronic obstructive pulmonary disease, diabetes mellitus, documented exposure to organophosphates or heavy metals or polychlorinated biphenyls.

13. Known nutritional deficiency (vitamin B12, vitamin D, iron or zinc) within 3 months prior to the study start.

14. Use of illicit drugs within the past 6 months prior to study start.

15. Lyme disease, porphyria, rheumatoid arthritis, Hansen's disease (leprosy) or use of antineoplastic chemotherapeutic agents.

16. Patients considered by researchers that are not suitable to the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Naloxone
Naloxone at an sublingual dose of 40 mg daily for one week will be given to each subject. Subjects will self-administer the drug at supervision in the primary care center.
Placebo
Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.

Locations

Country Name City State
China Xiangya Hospital Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (1)

Xiao Y, Huang X, Jing D, Huang Y, Zhang X, Shu Z, Huang Z, Su J, Li J, Zhang J, Chen M, Chen X, Shen M. Assessment of the Dermatology Life Quality Index (DLQI) in a homogeneous population under lifetime arsenic exposure. Qual Life Res. 2018 Dec;27(12):3209-3215. doi: 10.1007/s11136-018-1969-2. Epub 2018 Sep 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in symptom of itch Participants will be asked to report the severity of itch using a numeric rating scale (NRS) at the baseline and week 1 of the trial 1 week
Secondary Sleeping quality Measured by the Pittsburgh Sleep Quality Index at baseline and week 1 of the trial 1 week
Secondary Serological indicator Level of serum beta-endorphin will be tested at baseline and week 1 of the trial 1 week
Secondary Health-related quality of life Dermatology Life Quality Index (DLQI) at baseline and week 1 of the trial 1 week
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Not yet recruiting NCT05678309 - Establishment of a Patient Library in Patients With Pruritus Sine Materia