Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Abdominal Laparoscopic Surgery
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2011
CompletedFirst Posted
Study publicly available on registry
September 19, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMarch 14, 2012
March 1, 2012
5 months
September 15, 2011
March 12, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Sum of the time-weighted pain intensity differences (SPID) as recorded on the Visual Analog Scale (VAS) from baseline (time 0) to 24 hours following the first dose of study medication (SPID 24)
0 to 24 hours
Study Arms (5)
N1539 15 mg
EXPERIMENTALN1539 30 mg
EXPERIMENTALKetorolac
ACTIVE COMPARATORIV
Placebo
PLACEBO COMPARATORIV
N1539 7.5mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified
You may not qualify if:
- Use of ketorolac is contraindicated
- Use of general anesthesia is contraindicated
- Has a medical condition that could adversely impact subject participation
- Has diabetes mellitus and glycosylated hemoglobin (HbA1c) \>9.5 or history of prolonged uncontrolled diabetes
- Body mass index (BMI) less than 18 or greater than 35
- Has a history of intolerance or allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors, aspirin or other salicylates
- Known or suspected sleep apnea
- History of Hepatitis B or C
- Has a psychiatric disorder that impairs capability of subject to report pain
- Known to have chronic obstructive pulmonary disease (COPD) with carbon dioxide retention or chronic hypoxemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Study Sites (1)
Lotus Clinical Research LLC
Pasadena, California, 91105, United States
Related Publications (1)
Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7.
PMID: 30737315DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neil Singla, MD
Lotus Clinical Research, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2011
First Posted
September 19, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
March 14, 2012
Record last verified: 2012-03