Page last updated: 2024-10-30

loratadine and Pain

loratadine has been researched along with Pain in 6 studies

Loratadine: A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.
loratadine : A benzocycloheptapyridine that is 6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine substituted by a chloro group at position 8 and a 1-(ethoxycarbonyl)piperidin-4-ylidene group at position 11. It is a H1-receptor antagonist commonly employed in the treatment of allergic disorders.

Pain: An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.

Research Excerpts

ExcerptRelevanceReference
"In this open-label study (NCT01712009), women ≥ 18 years of age with newly diagnosed stage I-III breast cancer and an ECOG performance status ≤ 2 who were planning ≥ 4 cycles of adjuvant or neoadjuvant chemotherapy with pegfilgrastim support starting in cycle 1 were randomized 1:1:1 to receive naproxen, loratadine, or no treatment to prevent pegfilgrastim-associated bone pain."9.27NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim. ( Garcia, J; Guinigundo, AS; Kirshner, JJ; Kruter, F; Maxwell, CL; McDonald, MC; Morrow, PK; Reiner, M; Upchurch, TE; Vanni, L, 2018)
"This pilot study aimed to ascertain if bone pain induced by granulocyte-colony stimulating factors (G-CSFs) can be alleviated or eliminated by oral antihistamine loratadine."7.91Oral loratadine in the management of G-CSF-induced bone pain: a pilot study. ( Blazkova, S; Costello, V; Dowling, M; Duggan, C; Leary, EO; Murphy, L; Yousif, AD, 2019)
"Febrile neutropenia is an oncologic emergency that can result in serious consequences."5.42Severe pegfilgrastim-induced bone pain completely alleviated with loratadine: A case report. ( Copeland, L; Li, Q; Romeo, C, 2015)
"In this open-label study (NCT01712009), women ≥ 18 years of age with newly diagnosed stage I-III breast cancer and an ECOG performance status ≤ 2 who were planning ≥ 4 cycles of adjuvant or neoadjuvant chemotherapy with pegfilgrastim support starting in cycle 1 were randomized 1:1:1 to receive naproxen, loratadine, or no treatment to prevent pegfilgrastim-associated bone pain."5.27NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim. ( Garcia, J; Guinigundo, AS; Kirshner, JJ; Kruter, F; Maxwell, CL; McDonald, MC; Morrow, PK; Reiner, M; Upchurch, TE; Vanni, L, 2018)
"This pilot study aimed to ascertain if bone pain induced by granulocyte-colony stimulating factors (G-CSFs) can be alleviated or eliminated by oral antihistamine loratadine."3.91Oral loratadine in the management of G-CSF-induced bone pain: a pilot study. ( Blazkova, S; Costello, V; Dowling, M; Duggan, C; Leary, EO; Murphy, L; Yousif, AD, 2019)
"Febrile neutropenia is an oncologic emergency that can result in serious consequences."1.42Severe pegfilgrastim-induced bone pain completely alleviated with loratadine: A case report. ( Copeland, L; Li, Q; Romeo, C, 2015)
"Loratadine pretreatment, but neither guanethidine nor indomethacin, reduced edema."1.32Nociceptive and edematogenic responses elicited by a crude bristle extract of Lonomia obliqua caterpillars. ( de Castro Bastos, L; Guimarães, JA; Tonussi, CR; Veiga, AB, 2004)

Research

Studies (6)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's2 (33.33)29.6817
2010's4 (66.67)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Kirshner, JJ1
McDonald, MC1
Kruter, F1
Guinigundo, AS1
Vanni, L1
Maxwell, CL1
Reiner, M1
Upchurch, TE1
Garcia, J1
Morrow, PK1
Duggan, C1
Murphy, L1
Costello, V1
Leary, EO1
Yousif, AD1
Blazkova, S1
Dowling, M1
Romeo, C1
Li, Q1
Copeland, L1
Schlosburg, JE1
O'Neal, ST1
Conrad, DH1
Lichtman, AH1
de Castro Bastos, L1
Veiga, AB1
Guimarães, JA1
Tonussi, CR1
Green, GR1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim[NCT01712009]Phase 2600 participants (Actual)Interventional2012-11-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Percentage of Participants With Bone Pain (All Grades) in Cycle 1

Bone pain data were captured as part of standard adverse event (AE) reporting. (NCT01712009)
Timeframe: Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)

Interventionpercentage of participants (Number)
No Prophylaxis46.6
Naproxen 500 mg BID40.3
Loratadine 10 mg QD42.5

Area Under the Curve (AUC) for Patient-reported Bone Pain

Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from day 1 to 5 for each cycle. The AUC across cycles is the average of AUCs across the cycle. (NCT01712009)
Timeframe: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)

,,
Interventionunits on a scale * days (Least Squares Mean)
Cycle 1 (n=191, 196, 200)Cycle 2 (n=178, 180, 193)Cycle 3 (n=165, 176, 188)Cycle 4 (n=162, 169, 179)Across All Cycles (n=191, 196, 200)
Loratadine 10 mg QD7.05.96.15.66.3
Naproxen 500 mg BID7.75.65.55.26.6
No Prophylaxis9.37.36.87.28.0

Maximum Patient-reported Bone Pain by Cycle and Across Cycles

Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Maximum patient-reported bone pain is the maximum of each participant's bone pain values across survey Days 1-5 within each cycle. Across all cycles the maximum is the maximum of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An ANOVA model with treatment as explanatory term was used. (NCT01712009)
Timeframe: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)

,,
Interventionunits on a scale (Least Squares Mean)
Cycle 1 (n=191, 196, 200)Cycle 2 (n=178, 180, 193)Cycle 3 (n=165, 176, 188)Cycle 4 (n=162, 169, 179)Across All Cycles (n=191, 196, 200)
Loratadine 10 mg QD3.02.62.52.14.1
Naproxen 500 mg BID3.32.42.22.14.2
No Prophylaxis3.93.02.72.84.7

Mean Patient-reported Bone Pain by Cycle and Across Cycles

Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Mean patient-reported bone pain values are the average of each participant's bone pain values across survey days 1-5 within each cycle. Across all cycles the mean is the average of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An analysis of variance (ANOVA) model with treatment as explanatory term was used. (NCT01712009)
Timeframe: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)

,,
Interventionunits on a scale (Least Squares Mean)
Cycle 1 (n=191, 196, 200)Cycle 2 (n=178, 180, 193)Cycle 3 (n=165, 176, 188)Cycle 4 (n=162, 169, 179)Across all Cycles (n=191, 196, 200)
Loratadine 10 mg QD1.71.41.41.31.5
Naproxen 500 mg BID1.81.31.31.21.5
No Prophylaxis2.21.71.61.71.9

Number of Participants With Adverse Events (AEs)

"Severity was graded using CTCAE version 3. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal; • life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • congenital anomaly/birth defect; • other medically important serious event.~The investigator assessed each adverse event for relatedness to investigational product(s) or other protocol-required therapies." (NCT01712009)
Timeframe: From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.

,,
Interventionparticipants (Number)
Any adverse eventWorst grade of ≥ 2Worst grade of ≥ 3Worst grade of ≥ 4Serious adverse eventsFatal adverse eventsAE leading to discontinuation from studySAE leading to discontinuation from studyAny adverse event related to IPSAE related to IPAE related to IP leading to discontinuation of IPSAE related to IP leading to discontinuation of IPAny adverse event related to pegfilgrastimSAE related to pegfilgrastimAE related to / leading to discontinuation of PegSAE related to / leading to discontinuation of Peg
Loratadine 10 mg QD1941686320140327000105160
Naproxen 500 mg BID1921697330300533019196030
No Prophylaxis188164741834031000087461

Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles

Bone pain data were captured as part of standard adverse event (AE) reporting. (NCT01712009)
Timeframe: Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)

,,
Interventionpercentage of participants (Number)
Cycle 2 (n=178, 180, 193)Cycle 3 (n=165, 176, 188)Cycle 4 (n=162, 169, 179)Across All Cycles (n=191, 196, 200)
Loratadine 10 mg QD34.736.238.061.0
Naproxen 500 mg BID34.434.140.259.2
No Prophylaxis34.333.940.763.4

Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles

Bone pain data were captured as part of standard adverse event reporting. Severe bone pain is defined as grade 3 or 4 according to common terminology criteria for adverse events (CTCAE) version 3 grading criteria: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening or disabling. (NCT01712009)
Timeframe: Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)

,,
Interventionpercentage of participants (Number)
Cycle 1 (n=191, 196, 200)Cycle 2 (n=178, 180, 193)Cycle 3 (n=165, 176, 188)Cycle 4 (n=162, 169, 179)Across All Cycles (n=191, 196, 200)
Loratadine 10 mg QD4.50.00.00.04.5
Naproxen 500 mg BID3.11.71.10.64.1
No Prophylaxis4.71.11.81.95.8

Trials

1 trial available for loratadine and Pain

ArticleYear
NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2018, Volume: 26, Issue:4

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bone Diseases; Breas

2018

Other Studies

5 other studies available for loratadine and Pain

ArticleYear
Oral loratadine in the management of G-CSF-induced bone pain: a pilot study.
    British journal of nursing (Mark Allen Publishing), 2019, Feb-28, Volume: 28, Issue:4

    Topics: Administration, Oral; Adult; Aged; Bone Diseases; Female; Granulocyte Colony-Stimulating Factor; Hum

2019
Severe pegfilgrastim-induced bone pain completely alleviated with loratadine: A case report.
    Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, 2015, Volume: 21, Issue:4

    Topics: Aged; Bone Diseases; Female; Filgrastim; Granulocyte Colony-Stimulating Factor; Humans; Loratadine;

2015
CB1 receptors mediate rimonabant-induced pruritic responses in mice: investigation of locus of action.
    Psychopharmacology, 2011, Volume: 216, Issue:3

    Topics: Animals; Behavior, Animal; Disease Models, Animal; Dose-Response Relationship, Drug; Dronabinol; Fem

2011
Nociceptive and edematogenic responses elicited by a crude bristle extract of Lonomia obliqua caterpillars.
    Toxicon : official journal of the International Society on Toxinology, 2004, Mar-01, Volume: 43, Issue:3

    Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Arthropod Venoms; Dose-Response Relationship, Drug

2004
Treatment of ear pain in pilots in flight.
    Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2005, Volume: 95, Issue:4

    Topics: Aerospace Medicine; Anti-Allergic Agents; Humans; Loratadine; Pain; Rhinitis, Allergic, Seasonal; St

2005