Bone Pain
Conditions
Keywords
Granulocyte-colony stimulating factor
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.
Interventions
DRUGLoratadine
10 mg in a capsule
DRUGPlacebo
Administered via capsule
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Loratadine First Take treatment daily for 7 days.
Loratadine: 10 mg in a capsule
Placebo: Administered via capsule | 2 |
| Placebo First Take placebo daily for 7 days.
Loratadine: 10 mg in a capsule
Placebo: Administered via capsule | 1 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Assignment | Lost to Follow-up | 1 | 0 |
| First Assignment | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo First | Loratadine First |
|---|---|---|---|
| Age, Continuous | 46 years | 60 years | 39 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 3 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
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.
Time frame: 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.
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.
Time frame: 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.