Trial Outcomes & Findings for Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use (NCT NCT03883386)

Last Updated: 2020-10-22

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).

Results posted on

2020-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Loratadine First Take treatment daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule	Placebo First Take placebo daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule
First Assignment STARTED	2	1
First Assignment Surveys Begun	1	1
First Assignment COMPLETED	0	0
First Assignment NOT COMPLETED	2	1
Washout and Second Assignment STARTED	0	0
Washout and Second Assignment COMPLETED	0	0
Washout and Second Assignment NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Loratadine First Take treatment daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule	Placebo First Take placebo daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule
First Assignment Lost to Follow-up	1	0
First Assignment Withdrawal by Subject	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Loratadine First n=2 Participants Take treatment daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule	Placebo First n=1 Participants Take placebo daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule	Total n=3 Participants Total of all reporting groups
Age, Continuous	39 years n=5 Participants	60 years n=7 Participants	46 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).

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

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.

Outcome measures

Outcome data not reported

Adverse Events

Loratadine First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Kelly Walkovich

University of Michigan Medical School

Phone: 734-647-2893

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place