Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2014-005594-36-GB
EUCTR2014-005594-36-GB
Active, not recruiting
Phase 1

A Phase IV, Randomised, Double-Blind, Controlled, Parallel Group Trial to Evaluate the Effectiveness and Safety of Balneum Plus vs Emollient in the Treatment of Uraemic Pruritus in Haemodialysis Patients. - The DON'T ITCH Trial.

Portsmouth Hospitals NHS Trust0 sites58 target enrollmentNovember 20, 2015
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
DrugsBalneum Plus CreamE45 cream

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Portsmouth Hospitals NHS Trust
Enrollment
58
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 20, 2015
End Date
December 26, 2017
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •The participants must meet ALL of the following criteria to be considered eligible for the study:
  • •Male or Female, aged 18 years or above.
  • •Receiving haemodialysis for the treatment of ESRD for at least 3 months.
  • •Participant is willing and able to give informed consent for participation in the study.
  • •Self reported symptoms of uraemic pruritus. Itch will be defined as at least 3 episodes of itch during the last 2 weeks, several times a day for more than 5 minutes and being bothersome20\.
  • •VAS score of at least 2cm
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 29

Exclusion Criteria

  • •The participant may not enter the study if ANY of the following apply:
  • •Any other skin condition e.g. psoriasis, atopic dermatitis
  • •Taking any oral medication for UP other than antihistamines e.g. opiates, gabapentin
  • •Acute erythroderma, acute inflammatory, oozing or infected skin lesions
  • •Use of topical skin medication containing any active ingredients (anything other than simple emollient)
  • ••Any chronic liver disease in the participant’s past medical history that may cause itch, as deemed by the assessing clinician.
  • •Solid organ malignancy
  • •Cognitive impairment that may impact on their ability to fill in the quality of life questionnaire e.g. a previous diagnosis of dementia.
  • •Lack of a good understanding of English.
  • •Unwilling to apply the topical treatment as prescribed, including a previous history of poor\-compliance with any treatment.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
A pharmacological study on efficacy and safety of OM-85 in children with recurrent respiratory tract infections
EUCTR2016-002705-19-ITFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO288
Active, not recruiting
Phase 1
Clinical study assessing interchangeability between SB5 and Humira in patients with moderate to severe chronic plaque psoriasis.Moderate to severe plaque psioriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
EUCTR2022-000695-19-LTSamsung Bioepis Co., Ltd366
Active, not recruiting
Phase 1
A study to establish whether Linaclotide is effective in reducing abominal distension in men and women with constipation predominant IBSIrritable Bowel Syndrome with ConstipationMedDRA version: 20.0Level: LLTClassification code 10066868Term: Constipation predominant irritable bowel syndromeSystem Organ Class: 100000004856Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
EUCTR2016-000818-29-GBIronwood Pharmaceuticals, Inc.40
Not yet recruiting
Phase 4
A clinical study to evaluate the efficacy and safety of Nisha-Amalki capsules in preventing progression to Diabetes in patients with Pre-Diabetes
CTRI/2018/08/015503PHARMANZA HERBAL PVT LTD
Active, not recruiting
Phase 1
A study to assess the efficacy and safety of Sodium Zirconium Cyclosilicate (SZC) for the Management of High Potassium in Patients with Symptomatic Heart Failure with Reduced Ejection Fraction and Receiving SpironolactoneHyperkalemia in Patients with Symptomatic Heart Failure.MedDRA version: 21.1Level: PTClassification code 10020646Term: HyperkalaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2020-003312-27-HUAstraZeneca AB400