Study of Indomethacin Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02633969|
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Indomethacin Capsules low dose Drug: Indomethacin Capsules high dose||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIA, Open-label, Safety and Pharmacokinetic Study of Indomethacin Capsules in Pediatric Subjects 6 to <17 Years of Age With Mild to Moderate Acute Postoperative Pain Following Elective Surgery|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Experimental: Indomethacin Capsules low dose
Indomethacin Capsules low dose twice daily for up to three days
Drug: Indomethacin Capsules low dose
Experimental: Indomethacin Capsules high dose
Indomethacin Capsules high dose twice daily for up to three days
Drug: Indomethacin Capsules high dose
- Plasma Concentrations of indomethacin [ Time Frame: 0-12 hours after first dose of indomethacin ]The estimated typical value for clearance (tvCL) following a single indomethacin dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.
- Safety of Indomethacin Capsules low dose and high dose as assessed by the incidence of adverse events from baseline to Day 3 or early termination [ Time Frame: Baseline to Day 3/Early Termination ]
Tivorbex Capsules 20 mg and 40 mg were generally well tolerated. No deaths or SAEs were reported. Overall, 6 subjects (20.0%) experienced at least 1 TEAE during the study. All TEAEs were mild in intensity and 2 TEAEs (1 in each treatment group) of vomiting were considered to be related to the study drug.
The most common TEAEs were vomiting (13.3%) and nausea (6.7%). Vomiting and nausea were the only TEAEs reported in >1 subject in either group. The frequency of nausea and vomiting observed in this study is consistent with the findings from previous pediatric studies on NSAIDs.No gastrointestinal AEs commonly reported with NSAIDs, such as bleeding, ulceration, or perforation of the stomach and intestines were reported, nor were cardiovascular thrombotic events.No AEs of acute-type allergic reaction or bronchospasm were reported.
Vital sign and physical examination findings did not reveal any safety concerns; specifically no new onset hypertension was observed during the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633969
|United States, Alabama|
|Sheffield, Alabama, United States, 35660|
|United States, Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Coral Gables, Florida, United States, 33146|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|United States, Utah|
|Orem, Utah, United States, 84058|