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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 23 May 2016
Main ID:  NCT02168244
Date of registration: 18/06/2014
Prospective Registration: No
Primary sponsor: Icahn School of Medicine at Mount Sinai
Public title: Reduction of Pain Caused by Biologic Drugs in Psoriasis
Scientific title: Reduction of Injection-related Pain Caused by Subcutaneous Administration of Biologic Drugs in Psoriasis
Date of first enrolment: May 2014
Target sample size: 124
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02168244
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Mark Lebwohl, MD
Address: 
Telephone:
Email:
Affiliation:  Icahn School of Medicine at Mount Sinai
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients requiring treatment with a biologic drug

- Subjects must be able to understand and communicate with the investigator and comply
with the requirements of the study and must give written, signed and dated informed
consent before any study-related activity is performed

Exclusion Criteria:

- Patients receiving concurrent therapeutic injections for other indications

- Patients who have taken analgesics within 12 hours of their injection

- A past history of cold-, heat- or pressure-induced urticaria



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Pain
Psoriasis
Intervention(s)
Other: Heating Pack
Other: Ice pack
Primary Outcome(s)
Reduction of pain measured on a visual analogue scale [Time Frame: At time of injection]
Secondary Outcome(s)
Secondary ID(s)
GCO 14-0535
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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