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

• Status: Terminated
• Trial end date: 2019-10-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Lenograstim; Loratadine; Sargramostim

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