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

NCT03883386 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: HUM00152719
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Pain

Keywords

Granulocyte-colony stimulating factor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Study Arms (2)

Loratadine first

EXPERIMENTAL

Take treatment daily for 7 days.

Drug: Loratadine; Drug: Placebo

Placebo first

PLACEBO COMPARATOR

Take placebo daily for 7 days.

Drug: Loratadine; Drug: Placebo

Interventions

Loratadine DRUG

10 mg in a capsule

Also known as: Claritin

Loratadine first; Placebo first

Placebo DRUG

Administered via capsule

Loratadine first; Placebo first

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Loratadine

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Professor Kelly Walkovich
• Organization: University of Michigan Medical School

kwalkovi@med.umich.edu

734-647-2893

Study Officials

• Kelly Walkovich

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics and Communicable Diseases

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: June 24, 2019
• Primary Completion: October 18, 2019
• Study Completion: October 18, 2019
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)