Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery

Alkermes

Status and phase: Terminated; Phase 3

Conditions: Laparoscopic Surgery

Treatments: Drug: Placebo; Drug: Ketorolac Tromethamine; Drug: N1539

Study type: Interventional

Funder types: Industry

Identifiers

NCT01436032

N1539-05

Details and patient eligibility

About

The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 5 patient groups, including a placebo group

N1539 15 mg

Experimental group

Treatment:

Drug: N1539

Drug: N1539

Drug: N1539

N1539 30 mg

Experimental group

Treatment:

Drug: N1539

Drug: N1539

Drug: N1539

Ketorolac

Active Comparator group

Description:

IV

Treatment:

Drug: Ketorolac Tromethamine

Placebo

Placebo Comparator group

Description:

IV

Treatment:

Drug: Placebo

N1539 7.5mg

Experimental group

Treatment:

Drug: N1539

Drug: N1539

Drug: N1539