nimesulide and Pyrexia studies

nimesulide: structure
nimesulide : An aromatic ether having phenyl and 2-methylsulfonamido-5-nitrophenyl as the two aryl groups.

Research Excerpts

Excerpt	Relevance	Reference
"The aim of this study was to assess and compare the efficacy and tolerability of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections (URTIs)."	9.09	Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections. ( Cin, S; Köksal, Y; Ulukol, B, 1999)
"The efficacy and tolerability of nimesulide were compared with those of paracetamol in a nonblind randomised study that recruited 110 children (64 males, 46 females; aged 3 to 6 years) with inflammation of the upper respiratory tract and fever."	9.07	A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. ( Comito, A; Pieragostini, P; Polidori, G; Scaricabarozzi, I; Titti, G, 1993)
"Intraperitoneal indomethacin at 10 mg kg(-1) attenuated both phases of intravenous LPS (2 microg kg(-1)) fever, but the first more so than the second; at 50 mg kg(-1), it inhibited the febrile response completely."	7.71	Differential inhibition by nimesulide of the early and late phases of intravenous- and intracerebroventricular-LPS-induced fever in guinea pigs. ( Blatteis, CM; Li, S; Llanos-Q, J; Steiner, AA, 2001)
"The aim of this study was to assess and compare the efficacy and tolerability of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections (URTIs)."	5.09	Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections. ( Cin, S; Köksal, Y; Ulukol, B, 1999)
"The efficacy and tolerability of nimesulide were compared with those of paracetamol in a nonblind randomised study that recruited 110 children (64 males, 46 females; aged 3 to 6 years) with inflammation of the upper respiratory tract and fever."	5.07	A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. ( Comito, A; Pieragostini, P; Polidori, G; Scaricabarozzi, I; Titti, G, 1993)
"A double-blind, multi-centre study was carried out in 42 hospitalized children, aged 6 months to 8 years, suffering from acute respiratory tract infections with fever, to investigate the antipyretic activity of nimesulide."	5.07	Antipyretic effects of nimesulide in paediatric practice: a double-blind study. ( Lecomte, J; Monti, T; Pochobradsky, MG, 1991)
"Intraperitoneal indomethacin at 10 mg kg(-1) attenuated both phases of intravenous LPS (2 microg kg(-1)) fever, but the first more so than the second; at 50 mg kg(-1), it inhibited the febrile response completely."	3.71	Differential inhibition by nimesulide of the early and late phases of intravenous- and intracerebroventricular-LPS-induced fever in guinea pigs. ( Blatteis, CM; Li, S; Llanos-Q, J; Steiner, AA, 2001)
" Her mother ingested therapeutic doses of nimesulide, a non-steroidal anti-inflammatory (cyclo-oxygenase-2 inhibitor) drug, during the last 2 weeks of pregnancy."	3.70	Perinatal vasoconstrictive renal insufficiency associated with maternal nimesulide use. ( Holcberg, G; Landau, D; Marks, K; Polacheck, H; Shelef, I, 1999)
"The present experiment was designed to determine a dosage regimen (dose, interval of administration) in the dog for nimesulide, a nonsteroidal anti-inflammatory drug with in vitro selectivity for the inhibition of cyclo-oxygenase 2 (Cox-2), using a pharmacokinetic/pharmacodynamic (PK/PD) approach."	2.70	A pharmacokinetic/pharmacodynamic approach vs. a dose titration for the determination of a dosage regimen: the case of nimesulide, a Cox-2 selective nonsteroidal anti-inflammatory drug in the dog. ( Cester, CC; Haak, T; Laroute, V; Toutain, PL, 2001)
"Nimesulide was studied in comparison with paracetamol, according to a double-blind technique."	2.67	Pilot study of the antipyretic and analgesic activity of nimesulide paediatric suppositories. ( D'Apuzzo, V; Monti, T, 1992)
"Fever is an important symptom of underlying disease condition and in general is considered harmful in pediatric age group as it may lead to febrile seizures, stupor, dehydration increase work of breathing, discomfort and tachycardia."	2.41	Antipyretics in children. ( Bhatnagar, SK; Chandra, J, 2002)

Research

Studies (25)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Fetal Outcome 1 - Incidence of Early Preterm Delivery (<34 Weeks)

Fetal Outcome 2 - Incidence of Actual Birth Weight <2500g

Fetal Outcome 3 - Incidence of Actual Birth Weight <1500g

Fetal Outcome 4 - Incidence of Fetal Loss

Fetal Outcome 5 - Incidence of Spontaneous Abortion

Fetal Outcome 6 - Incidence of All Stillbirth

Fetal Outcome 7 - Incidence of Medical Termination of Pregnancy

Timeframe	Studies, this research(%)	All Research%
pre-1990	1 (4.00)	18.7374
1990's	13 (52.00)	18.2507
2000's	11 (44.00)	29.6817
2010's	0 (0.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Guo, SX	1
Cheng, Y	1
Locham, KK	1
Sodhi, M	1
Jindal, G	1
Dogan, MD	1
Ataoglu, H	1
Akarsu, ES	1
Amdekar, YK	1
Khubchandani, RP	1
Werner, MF	1
Souza, GE	1
Zampronio, AR	1
Reiner, M	1
Massera, E	1
Magni, E	1
Cunietti, E	2
Monti, M	2
Viganò, A	2
D'Aprile, E	2
Saligari, A	2
Scafuro, E	2
Scaricabarozzi, I	3
Polidori, G	1
Titti, G	1
Pieragostini, P	1
Comito, A	1
Tognella, S	1
Taniguchi, Y	1
Yokoyama, K	1
Inui, K	1
Deguchi, Y	1
Furukawa, K	1
Noda, K	1
Rajeshwari, K	1
Dubey, AP	1
Goyal, PK	1
Chandra, J	2
Unnikrishnan, G	1
Kumari, S	1
Passah, SM	1
Raghavendra, V	1
Agrewala, JN	1
Kulkarni, SK	1
Ulukol, B	1
Köksal, Y	1
Cin, S	1
Landau, D	1
Shelef, I	1
Polacheck, H	1
Marks, K	1
Holcberg, G	1
Lal, A	1
Gomber, S	1
Talukdar, B	1
Toutain, PL	1
Cester, CC	1
Haak, T	1
Laroute, V	1
Sharma, S	1
Bhatnagar, SK	1
Steiner, AA	1
Li, S	1
Llanos-Q, J	1
Blatteis, CM	1
Kapoor, SK	1
Sharma, J	1
Batra, B	1
Paul, E	1
Anand, K	1
Sharma, D	1
Tanaka, K	1
Shimotori, T	1
Makino, S	1
Aikawa, Y	1
Inaba, T	1
Yoshida, C	1
Takano, S	1
D'Apuzzo, V	1
Monti, T	2
Lecomte, J	1
Pochobradsky, MG	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)[NCT02409680]		11,976 participants (Actual)	Interventional	2016-03-23	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	Participants (Count of Participants)
Intervention Arm	189
Placebo Arm	230

Intervention	Participants (Count of Participants)
Intervention Arm	1078
Placebo Arm	1153

Intervention	Participants (Count of Participants)
Intervention Arm	78
Placebo Arm	101

Intervention	Participants (Count of Participants)
Intervention Arm	303
Placebo Arm	353

Intervention	Participants (Count of Participants)
Intervention Arm	134
Placebo Arm	152

Intervention	Participants (Count of Participants)
Intervention Arm	141
Placebo Arm	166

- Incidence of Medical Termination of Pregnancy (NCT02409680)
Timeframe: At delivery

Incidence of Hypertensive Disorders of Pregnancy

Intervention	Participants (Count of Participants)
Intervention Arm	42
Placebo Arm	30

- Hypertensive disorders of pregnancy is defined by the characterization of evidence of a hypertensive disorder, including either preeclampsia or eclampsia occurring during the pregnancy. (NCT02409680)
Timeframe: Evidence of hypertensive disorder during the pregnancy (prior to delivery/birth)

Incidence of Perinatal Mortality

Intervention	Participants (Count of Participants)
Intervention Arm	352
Placebo Arm	325

- Incidence of Perinatal Mortality (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Incidence of Preterm Birth

Intervention	Participants (Count of Participants)
Intervention Arm	264
Placebo Arm	309

The primary outcome of this study is incidence of preterm birth, which will be defined as delivery at or after 20 0/7 weeks and prior to 37 0/7 weeks. This will be determined based on actual date of delivery in comparison to the projected estimated due date (EDD), independent of whether or not the preterm delivery is indicated or spontaneous. (NCT02409680)
Timeframe: At delivery

Incidence of Small for Gestational Age (SGA)

Intervention	Participants (Count of Participants)
Intervention Arm	668
Placebo Arm	754

- Small for gestational age (SGA) as defined by the INTERGROWTH-21st standard (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Maternal Outcome 1 - Incidence of Vaginal Bleeding

Intervention	Participants (Count of Participants)
Intervention Arm	1506
Placebo Arm	1564

- Vaginal bleeding (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Maternal Outcome 2 - Incidence of Antepartum Hemorrhage

Intervention	Participants (Count of Participants)
Intervention Arm	214
Placebo Arm	246

- Antepartum hemorrhage (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Maternal Outcome 3 - Incidence of Postpartum Hemorrhage

Intervention	Participants (Count of Participants)
Intervention Arm	26
Placebo Arm	25

- Postpartum hemorrhage (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Maternal Outcome 4 - Incidence of Maternal Mortality

Intervention	Participants (Count of Participants)
Intervention Arm	54
Placebo Arm	43

- Incidence of Maternal Mortality (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Maternal Outcome 5 - Incidence of Late Abortion

Intervention	Participants (Count of Participants)
Intervention Arm	9
Placebo Arm	12

- Incidence of Late Abortion (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Maternal Outcome 6 - Change in Maternal Hemoglobin

Intervention	Participants (Count of Participants)
Intervention Arm	23
Placebo Arm	30

Hemoglobin < 7.0 gm/dl at 26-30 weeks gestation or a drop of 3.5+ gm/dl from screening to 26-30 weeks gestation (NCT02409680)
Timeframe: At enrollment, 4 weeks post enrollment, and 26-30 weeks GA.

Maternal Outcome 7 - Incidence of Preterm, Preeclampsia

Intervention	Participants (Count of Participants)
Intervention Arm	290
Placebo Arm	333

Early preterm delivery (<34 weeks) and hypertensive disorders (i.e.: preeclampsia) (NCT02409680)
Timeframe: At delivery or at Day 42 after delivery

Article	Year
[Research advance on pediatric antipyretic]. Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics, 2008, Volume: 10, Issue:6 Topics: Acetaminophen; Analgesics, Non-Narcotic; Aspirin; Fever; Humans; Ibuprofen; Sulfonamides	2008
Nimesulide. Indian pediatrics, 1997, Volume: 34, Issue:2 Topics: Age Factors; Anti-Inflammatory Agents, Non-Steroidal; Child; Fever; Humans; Pharmacokinetics; Sulfon	1997
Antipyretics in children. Indian journal of pediatrics, 2002, Volume: 69, Issue:1 Topics: Acetaminophen; Analgesics, Non-Narcotic; Aspirin; Child; Cyclooxygenase Inhibitors; Fever; Humans; I	2002

Article	Year
Nimesulide in the treatment of fever: a double-blind, crossover clinical trial. The Journal of international medical research, 1984, Volume: 12, Issue:2 Topics: Adult; Aged; Aspirin; Body Temperature; Clinical Trials as Topic; Dipyrone; Double-Blind Method; Fem	1984
A comparison of nimesulide vs paracetamol in the treatment of pyrexia in the elderly. Drugs, 1993, Volume: 46 Suppl 1 Topics: Acetaminophen; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method	1993
A comparison of nimesulide and paracetamol in the treatment of fever due to inflammatory diseases of the upper respiratory tract in children. Drugs, 1993, Volume: 46 Suppl 1 Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Child; Child, Preschool; Female; Fever; Huma	1993
Nimesulide in the treatment of hyperpyrexia in the aged. Double-blind comparison with paracetamol. Arzneimittel-Forschung, 1993, Volume: 43, Issue:2 Topics: Acetaminophen; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Blood Pressure; Bod	1993
Double blind randomized comparative evaluation of nimesulide and paracetamol as antipyretics. Indian pediatrics, 1998, Volume: 35, Issue:6 Topics: Abdominal Pain; Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Ax	1998
Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections. European journal of clinical pharmacology, 1999, Volume: 55, Issue:9 Topics: Acetaminophen; Acute Disease; Adolescent; Analgesics, Non-Narcotic; Analysis of Variance; Anti-Infla	1999
Antipyretic effects of nimesulide, paracetamol and ibuprofen-paracetamol. Indian journal of pediatrics, 2000, Volume: 67, Issue:12 Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Child, Preschool; Double-Blind Method; Drug	2000
A pharmacokinetic/pharmacodynamic approach vs. a dose titration for the determination of a dosage regimen: the case of nimesulide, a Cox-2 selective nonsteroidal anti-inflammatory drug in the dog. Journal of veterinary pharmacology and therapeutics, 2001, Volume: 24, Issue:1 Topics: Administration, Oral; Animals; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Cross-Over Studie	2001
Comparison of antipyretic effect of nimesulide and paracetamol in children attending a secondary level hospital. Indian pediatrics, 2002, Volume: 39, Issue:5 Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Child, Pres	2002
Pilot study of the antipyretic and analgesic activity of nimesulide paediatric suppositories. Drugs under experimental and clinical research, 1992, Volume: 18, Issue:2 Topics: Acetaminophen; Analysis of Variance; Anti-Inflammatory Agents, Non-Steroidal; Child; Child, Preschoo	1992
Antipyretic effects of nimesulide in paediatric practice: a double-blind study. Current medical research and opinion, 1991, Volume: 12, Issue:5 Topics: Acute Disease; Anti-Inflammatory Agents, Non-Steroidal; Child; Child, Preschool; Double-Blind Method	1991

Article	Year
Antipyretic effect of nimesulide and paracetamol in children. Indian pediatrics, 2002, Volume: 39, Issue:11 Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Fever; Huma	2002
Nimesulide and diclofenac inhibit lipopolysaccharide-induced hypothermia and tumour necrosis factor-alpha elevation in rats. Fundamental & clinical pharmacology, 2002, Volume: 16, Issue:4 Topics: Analysis of Variance; Animals; Body Temperature Regulation; Cyclooxygenase 2; Cyclooxygenase 2 Inhib	2002
Nimesulide vs. paracetamol: this trial needs to stand trial. Indian pediatrics, 2003, Volume: 40, Issue:2 Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Fever; Hosp	2003
Nimesulide-induced antipyresis in rats involves both cyclooxygenase-dependent and independent mechanisms. European journal of pharmacology, 2006, Aug-14, Volume: 543, Issue:1-3 Topics: Analgesics, Non-Narcotic; Animals; Arachidonic Acid; Body Temperature; Chemokine CCL3; Chemokine CCL	2006
Nimesulide. New clinical opportunities. Drugs, 1993, Volume: 46 Suppl 1 Topics: Anti-Inflammatory Agents, Non-Steroidal; Fever; Humans; Inflammation; Pain; Platelet Aggregation; Su	1993
Inhibition of brain cyclooxygenase-2 activity and the antipyretic action of nimesulide. European journal of pharmacology, 1997, Jul-09, Volume: 330, Issue:2-3 Topics: Analgesics, Non-Narcotic; Animals; Anti-Inflammatory Agents, Non-Steroidal; Body Temperature; Brain;	1997
Role of centrally administered melatonin and inhibitors of COX and NOS in LPS-induced hyperthermia and adipsia. Prostaglandins, leukotrienes, and essential fatty acids, 1999, Volume: 60, Issue:4 Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Body Temperature; Cyclooxygenase Inhibitors; Dinop	1999
Perinatal vasoconstrictive renal insufficiency associated with maternal nimesulide use. American journal of perinatology, 1999, Volume: 16, Issue:9 Topics: Acute Kidney Injury; Adult; Anti-Inflammatory Agents, Non-Steroidal; Arthralgia; Cough; Female; Feve	1999
Hypothermia with nimesulide. Indian pediatrics, 2001, Volume: 38, Issue:7 Topics: Anti-Inflammatory Agents, Non-Steroidal; Child, Preschool; Female; Fever; Humans; Hypothermia; India	2001
Differential inhibition by nimesulide of the early and late phases of intravenous- and intracerebroventricular-LPS-induced fever in guinea pigs. Neuroimmunomodulation, 2001, Volume: 9, Issue:5 Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Blood-Brain Barrier; Brain; Cyclooxygenase 1; Cycl	2001
Pharmacological studies of the new antiinflammatory agent 3-formylamino-7-methylsulfonylamino-6-phenoxy-4H-1-benzopyran-4-o ne. 1st communication: antiinflammatory, analgesic and other related properties. Arzneimittel-Forschung, 1992, Volume: 42, Issue:7 Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Experimental; Benzopyrans; Dogs; Edema;	1992

nimesulide and Pyrexia