Bone PainPhase 2NCT03883386
Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use
A Phase 2 study testing Loratadine in people with Bone Pain, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Bone Pain
- What is being tested?
- Loratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to 18 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
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.
- Conditions
- Bone Pain
- Being tested
- Loratadine, Placebo
- Keywords
- Granulocyte-colony stimulating factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoratadineDrug
Also called Claritin
10 mg in a capsule
PlaceboDrug
Administered via capsule
| Study group | Role | What they receive |
|---|---|---|
| Loratadine first | Experimental | Take treatment daily for 7 days. Receives: Drug: Loratadine; Drug: Placebo |
| Placebo first | Placebo comparator | Take placebo daily for 7 days. Receives: Drug: Loratadine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).
Secondary outcomes (1)
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.
Measured: Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start24 Jun 2019
- Primary completion18 Oct 2019
- Study completion18 Oct 2019
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Walkovich, University of Michigan
- Investigators
- Kelly Walkovich, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883386
- Sponsor's protocol ID
- HUM00152719
- Status last verified
- Sep 2020
- First submitted
- 18 Mar 2019
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use
- ClinicalTrials.gov ID
- NCT03883386
- Acronym / sponsor ID
- HUM00152719
- Conditions
- Bone Pain
- Keywords
- Granulocyte-colony stimulating factor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loratadine first | Experimental | Drug: Loratadine, Drug: PlaceboTake treatment daily for 7 days. |
| Placebo first | Placebo comparator | Drug: Loratadine, Drug: PlaceboTake placebo daily for 7 days. |
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LoratadineAlso: Claritin10 mg in a capsule | Drug | Loratadine first, Placebo first |
| PlaceboAdministered via capsule | Drug | Loratadine first, Placebo first |
Primary outcome
Change in Pain Severity Scores as Measured by the Brief Pain Inventory (BPI)
Time frame: 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.
1 secondary outcome
Change in Pain Interference in Patients as Measured by the Brief Pain Inventory (BPI)
Time frame: Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Walkovich principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Loratadine in people with Bone Pain, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Severity Scores as Measured by the Brief Pain Inventory (BPI) (time frame: Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.