Trial · NCT03816891
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 39
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 2a & 2b: Percent Change From Baseline in Weekly Average Worst Itch-Numeric Rating Scale (WI-NRS) Score | at Week 8 (Phase 2a); at Week 16 (Phase 2b) | Participants rated pruritus daily on the Worst Itch \[pruritis\] Numeric Rating Scale (WI-NRS: 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Secondary | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS at Week 8 | Baseline, Week 8 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). |
| Secondary | Phase 2a: Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Week 8 | Baseline, Week 8 | At every visit, participants rated the intensity of their average pruritus over previous 3 days on VAS 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis) |
| Secondary | Phase 2a: Change From Baseline in Weekly Average of WI-NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). |
| Secondary | Phase 2a: Percent Change From Baseline in Weekly Average of WI-NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Secondary | Phase 2a: Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24 | Participants rated intensity of their average pruritus over previous 3 days on VAS 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis) |
| Secondary | Phase 2a: Percent Change From Baseline in Pruritis Visual Analog Scale (VAS) Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24 | Participants rated intensity of their average pruritus over previous 3 days on VAS 0-10 line scale (0=no pruritis, 10=worst imaginable pruritis). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Secondary | Phase 2a: Change From Baseline in 5-D Pruritus Total Score Over Time | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 | Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in 5 domains: duration, degree, direction, disability and distribution. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) to 25 (most severe pruritus). |
| Secondary | Phase 2a: Percent Change From Baseline in 5-D Pruritus Total Score Over Time | Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 | Administered every 2 visits, the 5-D Pruritus Scale evaluates pruritus in five domains: duration, degree, direction, disability and distribution. The scores from each domain are added together to obtain a total 5-D score ranging from 5 (no pruritus) to 25 (most severe pruritus). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Secondary | Phase 2a: Percentage of Participants Achieving at Least a 4-point Reduction From Baseline in Weekly Average WI-NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rated pruritus daily on the Worst Itch \[pruritis\]-Numeric Rating Scale (WI-NRS; 0=no pruritus; 10=worst imaginable pruritus). |
| Secondary | Phase 2a: Change From Baseline in Sleep Loss VAS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24 | Participants rated intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness). |
| Secondary | Phase 2a: Percent Change From Baseline in Sleep Loss VAS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 20, 24 | Participants rated intensity of their average sleeplessness over previous 3 days on 0-10 line scale (0=no sleeplessness, 10=worst imaginable sleeplessness). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Secondary | Phase 2a: Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult). |
| Secondary | Phase 2a: Percent Change From Baseline in Weekly Average of Difficulty Falling Asleep NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rate difficulty falling asleep daily on Numerical Rating Scale (0=no difficulty, 10=extremely difficult). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Secondary | Phase 2a: Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rated daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep). |
| Secondary | Phase 2a: Percent Change From Baseline in Weekly Average of Sleep Quality NRS Over Time | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 | Participants rated daily sleep quality on Numerical Rating Scale (0=best possible sleep, 10=worst possible sleep). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
| Secondary | Phase 2a: Change From Baseline in Quality of Life (QoL) Measure Dermatology QoL Index (DLQI) Over Time | Baseline, Weeks 2, 4, 6, 8, 12, 16, 24 | QoL was assessed at designated visits and includes the DLQI whereby 0=no effect on quality of life; 30= extremely large effect on QoL. |
| Secondary | Phase 2a: Percent Change From Baseline in QoL Measure DLQI Over Time | Baseline, Weeks 2, 4, 6, 8, 12, 16, 24 | QoL was assessed at designated visits and includes the DLQI whereby 0=no effect on quality of life; 30= extremely large effect on QoL. |
| Secondary | Phase 2a: Change From Baseline in QoL Measure Itchy Quality of Life (ItchyQoL) Over Time | Baseline, Weeks 2, 4, 6, 8, 12, 16, 24 | ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). |
| Secondary | Phase 2a: Percent Change From Baseline in QoL Measure Itchy QoL Over Time | Baseline, Weeks 2, 4, 6, 8, 12, 16, 24 | ItchyQoL focuses on impact of pruritus on daily activities and on the level of psychological stress. It contains 22 items. The frequency items are scored using a 5-point Likert scale ranging from "never" to "all the time". The bother items are scored from 1 (not bothered) to 5 (severely bothered). The recall period in ItchyQoL is the past week. The ItchyQoL total score is defined as the sum of all 22-items scores. Total scores can be classified as little (0-30), mild (31-50), moderate (51-80), and severe (81-110). The least squares mean (LSM) and LSM difference were rounded up or down to the nearest single decimal place. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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GET https://conductscience.org/api/trials/v1/NCT03816891/registered