Post Operative PainPhase 3NCT02381132
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
A Phase 3 study testing Norco 7.5mg/325 and MNK155 in people with Post Operative Pain, run by Neil Singla at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Norco 7.5mg/325 and MNK155
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who provide written informed consent prior to enrollment.
- Male or female and 18 years of age or older.
- Subjects who are scheduled to undergo elective general surgery including, but not limited to the following surgical types:
- Abdominal surgery
- Orthopedic surgery
- Spine surgery
Show all 15Show fewer
- Genitourinary surgery
- Subjects classified as American Society of Anesthesiologists (ASA class I-III).
- 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;
- 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).
- Subjects who are willing and capable of understanding and cooperating with the requirements of the study.
- Subjects able to understand and communicate in English.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lotus Clinical Research, LLC
Pasadena, California, 91105
About this study
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.
Read the 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
- Conditions
- Post Operative Pain
- Being tested
- Norco 7.5mg/325, MNK155
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norco 7.5mg/325Drug
MNK155Drug
| Study group | Role | What they receive |
|---|---|---|
| MNK155 | Active comparator | Hydrocodone Bitartrate/Acetaminophen Extended-Release Tablets Receives: Drug: MNK155 |
| Norco 7.5mg/325mg | Active comparator | Norco 7.5mg/325mg Receives: Drug: Norco 7.5mg/325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain Control
Patient Global Assessment
Measured: 48 hours
Secondary outcomes (8)
Post-operative Pain Control
Patient Global Assessment
Measured: 120 hours
Post-operative Pain Control as Assessed by the Healthcare Professional
Healthcare Professional Global Assessments
Measured: 48 and 120 hours
Subject Satisfaction Regarding Ease of Use and Pill Burden
Patient Satisfaction/Ease of Use and Pill Burden Assessment
Measured: 48 hours and 120 hours after treatment initation
Subject Reported Worst Pain (Secondary to Analgesic Gaps)
Assessment of Worst Pain- Numerical Rating Scale (NRS)
Measured: 24 hours after treatment initiation
Total Daily Acetaminophen Exposure
Number of Dosed of Acetaminophen
Measured: 24 hours, 48 hours, 72 hours, 96 hours and 120 hours after treatment initation
Sleep Disturbance
Assessment of Sleep Disturbance/Pain Interference with Sleep
Measured: 24 hours, 48 hours and 72 hours after treatment initiation
Opioid Related Symptoms
Opioid Related Symptom Distress Scale (ORSDS)
Measured: 48 hours after treatment initiation
Pill Diversion
Number of Pills Remaining and Accountability
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neil Singla
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor-investigator, Neil Singla, Lotus Clinical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381132
- Sponsor's protocol ID
- LCR-MNK-155-01C
- Status last verified
- Mar 2016
- First submitted
- 20 Jan 2015
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02381132
- Acronym / sponsor ID
- LCR-MNK-155-01C
- Conditions
- Post Operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Neil SinglaUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MNK155 | Active comparator | Drug: MNK155Hydrocodone Bitartrate/Acetaminophen Extended-Release Tablets |
| Norco 7.5mg/325mg | Active comparator | Drug: Norco 7.5mg/325Norco 7.5mg/325mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects who provide written informed consent prior to enrollment.
- Male or female and 18 years of age or older.
- Subjects who are scheduled to undergo elective general surgery including, but not limited to the following surgical types:
- Subjects classified as American Society of Anesthesiologists (ASA class I-III).
- Female subjects are eligible only if all of the following apply:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norco 7.5mg/325 | Drug | Norco 7.5mg/325mg |
| MNK155 | Drug | MNK155 |
Primary outcome
Post-operative Pain Control
Time frame: 48 hours
Patient Global Assessment
8 secondary outcomes
Post-operative Pain Control
Time frame: 120 hours
Post-operative Pain Control as Assessed by the Healthcare Professional
Time frame: 48 and 120 hours
Subject Satisfaction Regarding Ease of Use and Pill Burden
Time frame: 48 hours and 120 hours after treatment initation
Subject Reported Worst Pain (Secondary to Analgesic Gaps)
Time frame: 24 hours after treatment initiation
Total Daily Acetaminophen Exposure
Time frame: 24 hours, 48 hours, 72 hours, 96 hours and 120 hours after treatment initation
Sleep Disturbance
Time frame: 24 hours, 48 hours and 72 hours after treatment initiation
Opioid Related Symptoms
Time frame: 48 hours after treatment initiation
Pill Diversion
Time frame: Day 5
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Norco 7.5mg/325 and MNK155 in people with Post Operative Pain, run by Neil Singla at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain Control (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.