Trial · NCT03883386
Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use
NCT03883386, Phase 2, Terminated, University of Michigan; results first posted 2020-10-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use. Trials, record NCT03883386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03883386
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use
- NCT number
- NCT03883386
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Bone Pain
- Interventions
- Loratadine, Placebo
- First posted
- 2019-03-20
- Last updated
- 2020-10-22
- Results first posted
- 2020-10-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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). | 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) | Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine). | Because only one participant completed an on-treatment survey, the data is not analyzable for any comparative purpose and therefore was not analyzed. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Assignment | STARTED | Loratadine First | 2 | |
| First Assignment | STARTED | Placebo First | 1 | |
| First Assignment | Surveys Begun | Loratadine First | 1 | |
| First Assignment | Surveys Begun | Placebo First | 1 | |
| First Assignment | COMPLETED | Loratadine First | 0 | |
| First Assignment | COMPLETED | Placebo First | 0 | |
| First Assignment | NOT COMPLETED | Loratadine First | 2 | |
| First Assignment | NOT COMPLETED | Placebo First | 1 | |
| Washout and Second Assignment | STARTED | Loratadine First | 0 | |
| Washout and Second Assignment | STARTED | Placebo First | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Loratadine First | 0 | 2 |
| Total, all-cause mortality | Placebo First | 0 | 1 |
| Total, other adverse events | Loratadine First | 0 | 2 |
| Total, other adverse events | Placebo First | 0 | 1 |
| Total, serious adverse events | Loratadine First | 0 | 2 |
| Total, serious adverse events | Placebo First | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Loratadine First vs Placebo First: deaths from any cause | Trial comparisons |
| Loratadine First vs Placebo First: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03883386
GET https://conductscience.org/api/trials/v1/NCT03883386/registered