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

Bone Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03883386
• Other study ID #: HUM00152719
• Status: Terminated
• Phase: Phase 2
• Start date: June 24, 2019
• Est. completion date: October 18, 2019

Study information

• Verified date: September 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 18, 2019
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Pain

Intervention

Drug:
• Loratadine
10 mg in a capsule
• Placebo
Administered via capsule

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Severity Scores as Measured by the Brief Pain Inventory (BPI)	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.	Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).
Secondary	Change in Pain Interference in Patients as Measured by the Brief Pain Inventory (BPI)	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.	Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).