Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 419 for:    shaare zedek

Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02032537
Recruitment Status : Unknown
Verified January 2014 by Linda Shavit, Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Linda Shavit, Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE January 6, 2014
First Posted Date  ICMJE January 10, 2014
Last Update Posted Date January 10, 2014
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
quality of life assessed by questionnaire [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus
Official Title  ICMJE Not Provided
Brief Summary

Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD).

Calmmax is a new topical cream that was introduced recently by Calmmax Pharma, an Israeli pharmaceutical company developed a topical cream based on active plant extracts for treatment of skin inflammation. We intend to conduct a prospective, double blind, placebo controlled, randomized trial that will assess the therapeutic effect of Calmmax cream on UP in a cohort of CKD and ESRD patients.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Calmmax Cream on UP in CKD Patients.
Intervention  ICMJE
  • Drug: Callmax cream application over affected skin
    Callmax cream application over affected skin Callmax cream or topical water containing emollient (placebo) will be applied by the patient on the affected skin area whenever the pruritus starts including night time. The frequency of application will be regulated by individual patients and increased according to pruritus severity.
  • Drug: Placebo
    Topical water containing emollient (placebo) will be applied by the patient on the affected skin area whenever the pruritus starts including night time. The frequency of application will be regulated by individual patients and increased according to pruritus severity. The data on efficacy, duration of effect and frequency of application will be collected.during the study.
Study Arms  ICMJE
  • Active Comparator: Callmax cream
    Intervention: Drug: Callmax cream application over affected skin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 8, 2014)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2016
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. History of pruritus of >8 weeks duration.
  2. Severity score of pruritus ≥5 as defined by VAS
  3. Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study (including Calmmax cream)
  4. Negative pregnancy test result for all participating women of childbearing age;

Exclusion Criteria:

  1. Known allergy to Calmmax cream
  2. Any acute illness
  3. Liver cirrhosis
  4. Active dermatological disorder other than UP
  5. Decompensated heart failure
  6. Inability to give informed consent
  7. Known poor adherence to medical recommendations
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02032537
Other Study ID Numbers  ICMJE Shavit.ctil
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Linda Shavit, Shaare Zedek Medical Center
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Itzchak Slotki, MD Shaare Zedek Medical Center
PRS Account Shaare Zedek Medical Center
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP