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

University of Michigan

Status and phase: Terminated; Phase 2

Conditions: Bone Pain

Treatments: Drug: Placebo; Drug: Loratadine

Study type: Interventional

Funder types: Other

Identifiers

NCT03883386

HUM00152719

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 12 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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3 participants in 2 patient groups, including a placebo group

Loratadine first

Experimental group

Description:

Take treatment daily for 7 days.

Treatment:

Drug: Loratadine

Drug: Placebo

Placebo first

Placebo Comparator group

Description:

Take placebo daily for 7 days.

Treatment:

Drug: Loratadine

Drug: Placebo