nimesulide and Cough studies

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

Cough: A sudden, audible expulsion of air from the lungs through a partially closed glottis, preceded by inhalation. It is a protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions, or to prevent aspiration of foreign materials into the lungs.

Research Excerpts

Excerpt	Relevance	Reference
"The aim of this study was to examine the influence of regulatory measures and other external factors on the rate of ADR reporting in Italy, focusing on four situations occurring in the last 10 years: ACE inhibitor-induced cough; HMG-CoA reductase inhibitors ('statins') and rhabdomyolysis; nimesulide and hepatic toxicity; and cyclo-oxygenase (COX)-2 selective inhibitors ('coxibs') and increase in cardiovascular risk."	3.74	Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy. ( Conforti, A; Leone, R; Montanaro, N; Moretti, U; Motola, D; Vaccheri, A; Vargiu, A; Velo, G, 2008)
" 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)

Research

Studies (2)

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	0 (0.00)	18.7374
1990's	1 (50.00)	18.2507
2000's	1 (50.00)	29.6817
2010's	0 (0.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Motola, D	1
Vargiu, A	1
Leone, R	1
Conforti, A	1
Moretti, U	1
Vaccheri, A	1
Velo, G	1
Montanaro, N	1
Landau, D	1
Shelef, I	1
Polacheck, H	1
Marks, K	1
Holcberg, G	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
Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy. Drug safety, 2008, Volume: 31, Issue:7 Topics: Adverse Drug Reaction Reporting Systems; Angiotensin-Converting Enzyme Inhibitors; Cardiovascular Di	2008
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

nimesulide and Cough