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Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use

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ClinicalTrials.gov Identifier: NCT03883386
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Kelly Walkovich, University of Michigan

Brief Summary:
G-CSF causes a release of histamine that may be a cause of chronic bone pain. Loratadine targets histamine, and so may be effective in reducing bone pain.The researchers plan to prospectively assess the effectiveness of loratadine for chronic bone pain in patients with chronic G-CSF use.

Condition or disease Intervention/treatment Phase
Bone Pain Drug: Loratadine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Loratadine first
Take treatment daily for 7 days.
Drug: Loratadine
10 mg in a capsule
Other Name: Claritin

Drug: Placebo
Administered via capsule

Placebo Comparator: Placebo first
Take placebo daily for 7 days.
Drug: Loratadine
10 mg in a capsule
Other Name: Claritin

Drug: Placebo
Administered via capsule




Primary Outcome Measures :
  1. Change in pain severity scores as measured by the Brief Pain Inventory (BPI) [ Time Frame: Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine). ]

    The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The questions ask participants to rate their pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."

    Modified BPI: Included the pain intensity subscale, it is a Numerical Rating Scale with 4 questions (3-6): each item is ranked where 0 is no pain - 10 the worst pain.

    The Modified BPI will be measured on Days 2, 4, and 6. The full BPI will be measured on Day 7. On day 7 only responses from questions 3-6 will be analyzed for this outcome and a mean composite score for Days 2, 4, 6, and 7 will be calculated.



Secondary Outcome Measures :
  1. Change in pain interference in patients as measured by the Brief Pain Inventory (BPI) [ Time Frame: Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine). ]
    Brief Pain Inventory (BPI) asks the participant to rate how their pain interferes with daily activities where "0" indicates "does not interfere and "10" indicates "completely interferes". The Pain Intensity Scale scores (Numerical Rating Scale (NRS)) for 7 questions: general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life from (BPI question 9A-G); 0 no life interference - 10 complete interference. Pain interference will be assessed on day 7 of each week.



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Ages Eligible for Study:   12 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of neutropenia
  • Granulocyte-colony stimulating factor (G-CSF) use for at least 3 months at least 4 times per month
  • Mean bone pain of at least a 2/10 as assessed by questions 3-6 of the Brief Pain Inventory (BPI)

Exclusion Criteria:

  • Other sources of chronic pain
  • Previously tried loratadine for 7 consecutive days or more for bone pain
  • Allergy to loratadine
  • Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883386


Contacts
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Contact: Lauren Merz 616-550-2734 lemerz@umich.edu

Locations
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United States, Michigan
The University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Lauren Merz    616-550-2734    lemerz@umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Kelly Walkovich University of Michigan

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Responsible Party: Kelly Walkovich, Associate Professor of Pediatrics and Communicable Diseases, University of Michigan
ClinicalTrials.gov Identifier: NCT03883386     History of Changes
Other Study ID Numbers: HUM00152719
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kelly Walkovich, University of Michigan:
Granulocyte-colony stimulating factor
Additional relevant MeSH terms:
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Loratadine
Sargramostim
Lenograstim
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action