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

• Sponsor: University of Michigan (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03883386
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Pain	Drug: Loratadine; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use
• Actual Study Start Date: Jun 24, 2019
• Actual Primary Completion Date: Oct 18, 2019
• Actual Study Completion Date: Oct 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Loratadine first Take treatment daily for 7 days.	Drug: Loratadine; 10 mg in a capsule; Other Names: Claritin ; Drug: Placebo; Administered via capsule
Placebo Comparator: Placebo first Take placebo daily for 7 days.	Drug: Loratadine; 10 mg in a capsule; Other Names: Claritin ; Drug: Placebo; Administered via capsule

Outcome Measures

Primary Outcome Measures

1. Change in Pain Severity Scores as Measured by the Brief Pain Inventory (BPI) [Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).]

   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.

Secondary Outcome Measures

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).]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Kelly Walkovich, University of Michigan

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 4, 2019

More Information

Publications

None provided.

• Responsible Party: Kelly Walkovich, Associate Professor of Pediatrics and Communicable Diseases, University of Michigan
• ClinicalTrials.gov Identifier: NCT03883386
• Other Study ID Numbers: HUM00152719
• First Posted: Mar 20, 2019
• Last Update Posted: Oct 22, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Kelly Walkovich, Associate Professor of Pediatrics and Communicable Diseases, University of Michigan: Granulocyte-colony stimulating factor
• Additional relevant MeSH terms: Loratadine

Study Results

Participant Flow

Arm/Group Title	Loratadine First	Placebo First
Arm/Group Description	Take treatment daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule	Take placebo daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule
Period Title: First Assignment
STARTED	2	1
Surveys Begun	1	1
COMPLETED	0	0
NOT COMPLETED	2	1
Period Title: First Assignment
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Loratadine First	Placebo First	Total
Arm/Group Description	Take treatment daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule	Take placebo daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule	Total of all reporting groups
Overall Participants	2	1	3
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	39	60	46
Sex: Female, Male (Count of Participants)
Female	1 50%	0 0%	1 33.3%
Male	1 50%	1 100%	2 66.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	2 100%	1 100%	3 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	2 100%	1 100%	3 100%

Outcome Measures

1. Primary Outcome

Title	Change in Pain Severity Scores as Measured by the Brief Pain Inventory (BPI)
Description	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.
Time Frame	Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).

Outcome Measure Data

Analysis Population Description

Because only one participant completed an on-treatment survey, the data is not analyzable for any comparative purpose and therefore was not analyzed.

Arm/Group Title	Loratadine	Placebo
Arm/Group Description	Take treatment daily for 7 days. Loratadine: 10 mg in a capsule	Take placebo by capsule daily for 7 days.
Measure Participants	0	0

2. Secondary Outcome

Title	Change in Pain Interference in Patients as Measured by the Brief Pain Inventory (BPI)
Description	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.
Time Frame	Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).

Outcome Measure Data

Analysis Population Description

Because only one participant completed an on-treatment survey, the data is not analyzable for any comparative purpose and therefore was not analyzed.

Arm/Group Title	Loratadine	Placebo
Arm/Group Description	Take treatment daily for 7 days. Loratadine: 10 mg in a capsule	Take placebo by capsule daily for 7 days.
Measure Participants	0	0

Adverse Events

Time Frame	Up to 5 weeks' following was planned; 2 weeks was the longest anyone actually participated.
Arm/Group Title	Loratadine First		Placebo First
Arm/Group Description	Take treatment daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule		Take placebo daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule
All Cause Mortality
	Loratadine First		Placebo First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Serious Adverse Events
	Loratadine First		Placebo First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Loratadine First		Placebo First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.