Trial · NCT03751111
Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone
NCT03751111, Phase 1, Phase 2, Completed, Xiangya Hospital of Central South University; results first posted 2025-04-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone. Trials, record NCT03751111. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03751111
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Chronic Itch in Patients Under Arsenic Exposure With Naloxone
- NCT number
- NCT03751111
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 126 participants, actual
- Lead sponsor
- Xiangya Hospital of Central South University
- Conditions
- Chronic Pruritus
- Interventions
- Naloxone, Placebo
- First posted
- 2018-11-23
- Last updated
- 2025-04-20
- Results first posted
- 2025-04-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Numeric Rating Scale for Itch | 1 week | Participants will be invited to report the severity of itch using the Numeric Rating Scale (NRS) for Itch at the baseline and week 1 of the trial. Numeric Rating Scale (NRS) for Itch is a self-reported scale to measure the intensity of itch, with a range of score from 0 to 10. Higher scores indicate stronger itching, with a score of 1 or 2 suggesting mild itching, a score between 3 and 6 suggesting moderate itching, and a greater than 7 indicating severe itching. |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | 1 week | Measured by the Pittsburgh Sleep Quality Index (PSQI) at baseline and week 1 of the trial. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties. |
| Secondary | Serological Indicator | 1 week | Level of serum beta-endorphin will be tested at baseline and week 1 of the trial |
| Secondary | Dermatology Life Quality Index (DLQI) | 1 week | Dermatology Life Quality Index (DLQI) at baseline and week 1 of the trial. It consists of ten questions which ask about symptoms, feelings, daily activities, leisure, work, school, personal relationships, and treatment. Every question asked relates to the previous week. The user can tick a box in either: 'not at all', 'a little', 'a lot' or 'very much'. Questions are scored from 0 to 3 and totalled, giving an overall score out of 30. The final score ranges from 0 (no impact on quality of life) to 30 (maximum impairment). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Numeric Rating Scale for Itch | 1 week | Intention-to-treat population | score on a scale (0~10) | MEAN |
| SECONDARY | Pittsburgh Sleep Quality Index (PSQI) | 1 week | units on a scale (0-21) | MEDIAN | |
| SECONDARY | Serological Indicator | 1 week | |||
| SECONDARY | Dermatology Life Quality Index (DLQI) | 1 week | units on a scale (0-30) | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Numeric Rating Scale for Itch | Naloxone | 6.42 | Standard Deviation 2.15 | score on a scale (0~10) | |
| Numeric Rating Scale for Itch | Placebo | 7.8 | Standard Deviation 1.99 | score on a scale (0~10) | |
| Pittsburgh Sleep Quality Index (PSQI) | Naloxone | 9.5 | Inter-Quartile Range 5 to 13 | units on a scale (0-21) | |
| Pittsburgh Sleep Quality Index (PSQI) | Placebo | 10.0 | Inter-Quartile Range 6 to 12.5 | units on a scale (0-21) | |
| Dermatology Life Quality Index (DLQI) | Naloxone | 9.2 | Standard Deviation 6.7 | units on a scale (0-30) | |
| Dermatology Life Quality Index (DLQI) | Placebo | 12.1 | Standard Deviation 6.2 | units on a scale (0-30) |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Naloxone | 62 | |
| Overall Study | STARTED | Placebo | 64 | |
| Overall Study | COMPLETED | Naloxone | 50 | |
| Overall Study | COMPLETED | Placebo | 32 | |
| Overall Study | NOT COMPLETED | Naloxone | 12 | |
| Overall Study | NOT COMPLETED | Placebo | 32 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cold | Respiratory, thoracic and mediastinal disorders | Naloxone | 1 | 62 | 1 |
| other | Cold | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 64 | 1 |
| other | Headache | Nervous system disorders | Naloxone | 2 | 62 | 2 |
| other | Headache | Nervous system disorders | Placebo | 1 | 64 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Naloxone | 0 | 62 |
| Total, all-cause mortality | Placebo | 0 | 64 |
| Total, other adverse events | Naloxone | 3 | 62 |
| Total, other adverse events | Placebo | 2 | 64 |
| Total, serious adverse events | Naloxone | 0 | 62 |
| Total, serious adverse events | Placebo | 0 | 64 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30203303 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Naloxone vs Placebo: deaths from any cause | Trial comparisons |
| Naloxone vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03751111
GET https://conductscience.org/api/trials/v1/NCT03751111/registered