A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain
Information source: Lotus Clinical Research, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Operative Pain
Intervention: Norco 7.5mg/325 (Drug); MNK155 (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Neil Singla Overall contact: Anne Arriaga, Phone: 626-397-3412, Email: anne@lotuscr.com
Summary
The purpose of this study is to explore the clinical characteristics oral MNK155 and Norco®
7. 5mg/325mg when used for the treatment of moderate to severe post operative pain.
Clinical Details
Official title: A Randomized, Open Label, Prospective Study to Explore the Clinical Characteristics of Oral MNK155 and Norco 7.5mg/325 When Used for the Treatment of Moderate to Severe Post Operative Pain
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Post-operative Pain Control
Secondary outcome: Post-operative Pain ControlPost-operative Pain Control as Assessed by the Healthcare Professional Subject Satisfaction Regarding Ease of Use and Pill Burden Subject Reported Worst Pain (Secondary to Analgesic Gaps) Total Daily Acetaminophen Exposure Sleep Disturbance Opioid Related Symptoms Pill Diversion
Detailed description:
This is a single center, open label, prospective, randomized study on adult post operative
subjects who are expected to require oral opioid analgesia for at least 48 hours after
surgery. The main study drug of interest in this study is MNK 155. Norco® 7. 5mg/325mg is
being utilized only as active comparator.
Subjects will be at least 18 years of age and will be scheduled to undergo elective surgery.
The following surgical types will be allowed, although the list is not all inclusive:
- Abdominal surgery
- Soft tissue surgery
- Orthopedic surgery
- Spine surgery
- Genitourinary surgery
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Subjects who provide written informed consent prior to enrollment.
2. Male or female and 18 years of age or older.
3. Subjects who are scheduled to undergo elective general surgery including, but not
limited to the following surgical types:
- Abdominal surgery
- Orthopedic surgery
- Spine surgery
- Genitourinary surgery
4. Subjects classified as American Society of Anesthesiologists (ASA class I-III).
5. Female subjects are eligible only if all of the following apply:
- Not pregnant (subjects of child bearing potential must have a negative beta
human chorionic gonadotropin (β-hCG) pregnancy test before surgery);
- Not lactating;
- Not planning to become pregnant within the duration of the study;
6. Subjects who are expected to have acute pain requiring oral opioid analgesics for at
least 48 hours during the post operative period (either inpatient or outpatient).
7. Subjects who are willing and capable of understanding and cooperating with the
requirements of the study.
8. Subjects able to understand and communicate in English.
Exclusion Criteria:
1. Subjects with a medical condition that, in the Investigator's opinion, could adversely
impact the subject's participation, safety, or conduct of the study such as but not
limited to a history of severe renal or hepatic impairment, severe active hepatic disease,
or any other clinically significant medical condition that may preclude safe study
participation.
Locations and Contacts
Anne Arriaga, Phone: 626-397-3412, Email: anne@lotuscr.com
Lotus Clinical Research, LLC, Pasadena, California 91105, United States; Recruiting Anne Arriaga, Phone: 626-397-3412, Email: anne@lotuscr.com Sonia Singla, DO, Principal Investigator
Additional Information
Starting date: November 2014
Last updated: March 2, 2015
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