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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-24

Study Completion Date

2019-10-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Bone Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Loratadine first

Take treatment daily for 7 days.

Group Type EXPERIMENTAL

Loratadine

Intervention Type DRUG

10 mg in a capsule

Placebo

Intervention Type DRUG

Administered via capsule

Placebo first

Take placebo daily for 7 days.

Group Type PLACEBO_COMPARATOR

Loratadine

Intervention Type DRUG

10 mg in a capsule

Placebo

Intervention Type DRUG

Administered via capsule

Interventions

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Loratadine

10 mg in a capsule

Intervention Type DRUG

Placebo

Administered via capsule

Intervention Type DRUG

Other Intervention Names

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Claritin

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No