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Poor enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loratadine first | Experimental | Take treatment daily for 7 days. |
|
| Placebo first | Placebo Comparator | Take placebo daily for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loratadine | Drug | 10 mg in a capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Walkovich | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Loratadine First | Take treatment daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule |
| FG001 | Placebo First | Take placebo daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Assignment |
|
| ||||||||||||||||||||||||
| Washout and Second Assignment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Loratadine First | Take treatment daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule |
| BG001 | Placebo First | Take placebo daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Because only one participant completed an on-treatment survey, the data is not analyzable for any comparative purpose and therefore was not analyzed. | Posted | Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine). |
|
Up to 5 weeks' following was planned; 2 weeks was the longest anyone actually participated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Loratadine First | Take treatment daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Kelly Walkovich | University of Michigan Medical School | 734-647-2893 | kwalkovi@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2019 | Sep 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Placebo | Drug | Administered via capsule |
|
| Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine). |
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|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Loratadine |
Take treatment daily for 7 days. Loratadine: 10 mg in a capsule |
| OG001 | Placebo | Take placebo by capsule daily for 7 days. |
|
| 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. | Because only one participant completed an on-treatment survey, the data is not analyzable for any comparative purpose and therefore was not analyzed. | Posted | Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine). |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Placebo First | Take placebo daily for 7 days. Loratadine: 10 mg in a capsule Placebo: Administered via capsule | 0 | 1 | 0 | 1 | 0 | 1 |
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| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |