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

Phase 2

Terminated

• Conditions: Bone Pain
• Interventions: Drug: Loratadine; Drug: Placebo

• Registration Number: NCT03883386
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-20
• Study Start: 2019-06-24
• Primary Completion: 2019-10-18
• Study Completion: 2019-10-18
• Status Verified: 2020-09
• Results First Submitted: 2020-09-28
• Results First Submitted QC: 2020-09-28
• Last Update Submitted: 2020-09-28
• Results First Posted: 2020-10-22
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Loratadine first	Loratadine	Take treatment daily for 7 days.
Loratadine first	Placebo	Take treatment daily for 7 days.
Placebo first	Loratadine	Take placebo daily for 7 days.
Placebo first	Placebo	Take placebo daily for 7 days.

Primary Outcome Measures

Name	Time	Method
Change in Pain Severity Scores as Measured by the Brief Pain Inventory (BPI)	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

Name	Time	Method
Change in Pain Interference in Patients as Measured by the Brief Pain Inventory (BPI)	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.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States