Laparoscopic SurgeryPhase 3NCT01436032
Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery
A Phase 3 study testing N1539 and Ketorolac Tromethamine in people with Laparoscopic Surgery, run by Alkermes, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- N1539 and Ketorolac Tromethamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Mar 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Lotus Clinical Research LLC
Pasadena, California, 91105
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Abdominal Laparoscopic Surgery
The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.
- Conditions
- Laparoscopic Surgery
- Being tested
- N1539, Ketorolac Tromethamine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1539Drug
IV
N1539Drug
IV
N1539Drug
IV
Ketorolac TromethamineDrug
IV
PlaceboDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| N1539 15 mg | Experimental | Not described Receives: Drug: N1539 |
| N1539 30 mg | Experimental | Not described Receives: Drug: N1539 |
| Ketorolac | Active comparator | IV Receives: Drug: Ketorolac Tromethamine |
| Placebo | Placebo comparator | IV Receives: Drug: Placebo |
| N1539 7.5mg | Experimental | Not described Receives: Drug: N1539 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0 to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil Singla, MD, Principal investigator, Lotus Clinical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436032
- Sponsor's protocol ID
- N1539-05
- Status last verified
- Mar 2012
- First submitted
- 15 Sep 2011
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30737315
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Abdominal Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01436032
- Acronym / sponsor ID
- N1539-05
- Conditions
- Laparoscopic Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Sep 2011 (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 determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| N1539 15 mg | Experimental | Drug: N1539 |
| N1539 30 mg | Experimental | Drug: N1539 |
| Ketorolac | Active comparator | Drug: Ketorolac TromethamineIV |
| Placebo | Placebo comparator | Drug: PlaceboIV |
| N1539 7.5mg | Experimental | Drug: N1539 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| N1539IV | Drug | N1539 7.5mg |
| N1539IV | Drug | N1539 15 mg |
| N1539IV | Drug | N1539 30 mg |
| Ketorolac TromethamineIV | Drug | Ketorolac |
| PlaceboIV | Drug | Placebo |
Primary outcome
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)
Time frame: 0 to 24 hours
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 14 Mar 2012.
- Derived from this study: PubMed 30737315Viscusi 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.
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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.
Neil Singla, MD principal investigator
Lotus Clinical Research, LLC
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 N1539 and Ketorolac Tromethamine in people with Laparoscopic Surgery, run by Alkermes, Inc. 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 1 inclusion and 10 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 14 Mar 2012. 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. Some participants in this study may receive a placebo. 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?
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) (time frame: 0 to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01436032, which also lists 1 linked publication.
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 14 Mar 2012.