Trial · NCT04728984
A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet
NCT04728984, Phase 3, Unknown, Shenyang Sunshine Pharmaceutical Co., LTD.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet. Trials, record NCT04728984. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04728984
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet
- NCT number
- NCT04728984
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 135 participants, estimated
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Conditions
- Uremic Pruritus
- Interventions
- Nalfurafine Hydrochloride, Nalfurafine Hydrochloride+Placebo, Placebo
- First posted
- 2021-01-28
- Last updated
- 2021-01-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Variation in VAS of Nalfurafine Hydrochloride versus Placebo | up to 38(+1) days | The Variation = the mean of the daily maximum VAS value during the observation period before administration(D8-14) - the mean of the daily maximum VAS value during the administration period (D25-31). Only the days on which the VAS values were recorded during the day and night were evaluated. |
| Secondary | Variation in pruritus scores based on the Hsie-Kawashima pruritus severity assessment method | up to 38(+1) days | Pruritus scores were assessed during the observation period before administration(D8-14) and administration period (D25-31), and only the days when pruritus scores were recorded during the day and night were evaluated. |
| Secondary | Variation in nocturnal pruritus scores based on the Hsie-Kawashima pruritus severity assessment method (improvement of pruritus-induced sleep disorders). | up to 38(+1) days | After calculating the mean values of nocturnal pruritus scores during the observation period before administration(D8-14) and administration period (D25-31), the variation was calculated. |
| Secondary | Improvement degree of VAS | up to 38(+1) days | The average VAS value of the observation period before administration (D8-14) and the average VAS value of the administration period (D25-31) were calculated, and the improvement degree was determined as very effective, effective and ineffective according to the variation of the average VAS value. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04728984
GET https://conductscience.org/api/trials/v1/NCT04728984/registered