Trial · NCT03928093
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in the mean pain scores between pregabalin and placebo group: VAS | 12 weeks | It will be measured as difference in the mean pain values pre- and post-intervention for each group using the Visual Analog Scale (VAS).It is a 10 cm line with anchor statements on the left (no pain) and on the right (worst pain ever). The patient is asked to mark their pain level on the line.The pain is scored using the VAS by measuring the distance in centimeters (0-10) from the "no pain" anchoring point. |
| Secondary | Proportion of patients on pregabalin achieving a ≥75% reduction in their mean pain intensity score across last 7 days of treatment compared to baseline/wash-out | 12 weeks | Proportion of patients on pregabalin achieving a ≥75% reduction in their mean pain intensity score across last 7 days of treatment compared to baseline/wash-out |
| Secondary | Proportion of patients on pregabalin achieving a ≥50% reduction in their mean pain intensity score across last 7 days of treatment compared to baseline/wash-out | 12 weeks | Proportion of patients on pregabalin achieving a ≥50% reduction in their mean pain intensity score across last 7 days of treatment compared to baseline/wash-out |
| Secondary | Difference in the average pain score assessed using VAS between first and second treatment periods (period effect) | 24 weeks | Difference in the average pain score assessed using VAS, reported by the patient between first and second treatment periods. Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (0 -no pain) and on the right (10- worst pain ever). The patient is asked to mark their pain level on the line. The pain is scored using the VAS by measuring the distance in centimeters (0-10) from the "no pain" anchoring point. |
| Secondary | Proportion of patients on pregabalin achieving a ≥75% reduction in their mean itch intensity score across last 7 days of treatment compared to baseline/wash-out | 24 weeks | Proportion of patients on pregabalin achieving a ≥75% reduction in their mean itch intensity score across last 7 days of treatment compared to baseline/wash-out.The intensity of itch is measured using the Visual Analog Scale for itch(VAS).It is a 10 cm line with anchor statements on the left (no itching) and on the right (worst possible itching). The patient is asked to mark the intensity of itch on the line. The itch is scored using the VAS by measuring the distance in centimeters (0-10)from the "no itch" anchoring point. |
| Secondary | Proportion of patients on pregabalin achieving a ≥50% reduction in their mean itch intensity score across last 7 days of treatment compared to baseline/wash-out | 12 weerks | Proportion of patients on pregabalin achieving a ≥50% reduction in their mean itch intensity score across last 7 days of treatment compared to baseline/wash-out |
| Secondary | Difference in the average itch score as assessed using VAS between the first and the second treatment periods (period effect). | 24 weeks | Difference in the average itch score as assessed using VAS( reported by the patient) between the first and the second treatment periods (period effect). The intensity of itch is measured using the Visual Analog Scale for itch (VAS).It is a 10 cm line with anchor statements on the left (0- no itching) and on the right (10 -worst possible itching). The patient is asked to mark the intensity of itch on the line. The itch is scored using the VAS by measuring the distance in centimeters (0-10) from the "no itch" anchoring point. |
| Secondary | Changes in the Quality of Life in Epidermolysis Bullosa Questionnaire score(QOLEB) for patients >18yrs in the intervention versus placebo | 24 weeks | Changes in the QOLEB for patients \>18yrs in the intervention versus placebo. QOLEB is a measurement tool containing 17questions.Each question has a score range from 0-3.Total score range is between 0 and 51. iscorEB is a measurement tool for evaluating the disease severity in EB patient.It evaluates the cutaneous,mucosal and other organ impact of EB and includes clinician and patient reported outcomes in a single instrument. Score ranges between 0-120 for both reported outcomes. |
| Secondary | Changes in iscorEB (instrument for scoring clinical outcomes for research of EB), patient portion score in the intervention versus placebo | 24 weeks | iscorEB is a measurement tool for evaluating the disease severity in EB patient. It evaluates the cutaneous, mucosal and other organ impact of EB and includes clinician and patient reported outcomes in a single instrument. Score ranges between 0-120 for both reported outcomes. Patient portion of this instrument contains 15 questions. Each question has a score range from 0-8.Total score range for iscorEB patient portion is between 0 and 120. Reduction in iscorEB scores indicates improvement. An increase in score indicates deterioration. |
| Other | Correlation between pain score (as measured by VAS), iscorEB patient portion score and QOLEB (for patients over 18 yrs) total scores. | 24 weeks | Correlation between pain score, as measured by Visual Analog Scale (VAS), iscorEB (instrument for scoring clinical outcomes for research of EB)- patient portion score, and Quality of Life in Epidermolysis Bullosa Questionnaire (QOLEB) score (for patients over 18 years). Please see full description of the mentioned instruments above. |
| Other | Correlation between pain score( as measured by VAS) and iscorEB clinician portion score and Epidermolysis Bullosa Disease Activity and Scarring Index(EBDASI) score. | 24 weeks | Correlation between pain score(as measured by Visual Analog Scale), iscorEB (instrument for scoring clinical outcomes for research of EB)- clinician portion score and EBDASI total score.Total EBDASI score ranges of 0-42, 43-106 and 107-506 corresponded to mild, moderate and severe disease respectively. Reduction in EBDASI activity scores of greater than 9 indicated clinically significant improvement. An increase of 3 in the activity score indicated deterioration. iscorEB is a measurement tool for evaluating the disease severity in EB patient. It evaluates the cutaneous, mucosal and other organ impact of EB and includes clinician and patient reported outcomes in a single instrument. Clinician score ranges between 0-120 between. Reduction in iscorEB scores indicates improvement. An increase in score indicates deterioration. |
| Other | Proportion of patients experiencing adverse events, minor, severe and serious (life-threatening) | 24 weeks | Proportion of patients experiencing adverse events |
| Other | Proportion of patients that dropped out of the study as a result of an adverse event | 24 weeks | Proportion of patients that dropped out of the study as a result of an adverse event |
| Other | Correlation between itch score (as measured by VAS),iscorEB patient portion and QOLEB (for patients over 18 yrs) total scores. | 24 weeks | Correlation between itch score( as measured by VAS),iscorEB patient portion, and QOLEB (for patients over 18 yrs.) total scores. |
| Other | Correlation between itch score( as measured by VAS) and iscorEB clinician and Epidermolysis Bullosa Disease Activity and Scarring Index(EBDASI) | 24 weeks | Correlation between itch score(as measured by VAS) and iscorEB clinician and EBDASI total scores. Total EBDASI score ranges of 0-42, 43-106 and 107-506 corresponded to mild, moderate and severe disease respectively. Reduction in EBDASI activity scores of greater than 9 indicated clinically significant improvement. An increase of 3 in the activity score indicated deterioration. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
For software
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