Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

NCT01825655 | Terminated Phase 4 Results

• 2 other identifiers: HM20003779IIS2012-003
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is determine if long acting antihistamine like cetirizine can help with itching induced by opioid pain medications.

Conditions

Pruritus

Outcome Measures

Primary Outcomes (1)

• Change in Itch Score

  Itch score will be used to analyze our primary outcome. The subjects will have an itch score at baseline and compared to itch score at 3hrs post intervention. Itch score is measured on a scale of 1 to 4, with lower scores indicating less itchiness.

  Baseline to 3 hours

Study Arms (2)

Cetirizine

ACTIVE COMPARATOR

zyrtec 10mg, oral, one time

Drug: Cetirizine

Sugar pill

PLACEBO COMPARATOR

Placebo, one pill, one time

Drug: Placebo or sugar pill

Interventions

Cetirizine DRUG

Cetirizine

Placebo or sugar pill DRUG

Sugar pill

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children age 6-18yrs on opioids who develop pruritus and are willing to participate in the study

You may not qualify if:

• Children with history of chronic urticaria
• Children with other chronic pruritic condition like eczema, contact dermatitis, psoriasis
• Children with known hypersensitivity to cetirizine/zyrtec
• Children on H1 antihistamine like diphenhydramine, hydroxyzine, cetirizine, loratadine, fexofenadine, chlorpheniramine within the last 7days prior to randomization
• Children who have received Ondansetron within 24hrs prior to randomization
• Children who are on Tricyclic antidepressants
• Children who are unwilling or unable to swallow the capsule.
• Children with chronic liver or kidney disease

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Pruritus

Interventions

Cetirizine; Sugars

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Limitations and Caveats

The study had to prematurely end due to difficulty in recruiting subjects. The sample size is not large enough to do any statistical analysis.

Results Point of Contact

• Title: Santhosh Kumar, MD
• Organization: Virginia Commonwealth University

santhosh.kumar@vcuhealth.org

804-628-1605

Study Officials

• Santhosh Kumar, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 5, 2013
• Study Start: September 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 10, 2018
• Results First Posted: September 11, 2018

Record last verified: 2018-09

Locations

US (1)