HysterectomyPhase 2NCT01084161
Study to Evaluate the Efficacy, Safety and Tolerability of N1539
A Phase 2 study testing N1539 and Morphine in people with Hysterectomy, run by Alkermes, Inc. at 12 sites in 3 countries.
Trial summary
To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- N1539 and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 486 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Mar 2010to Jan 2011
- Phase
- Phase 2
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate to severe pain with VAS of >/= 45 mm
- undergo open abdominal hysterectomy
- ASA I or II
- signed ICF
- BMI >18.5 and < 31.5 kg/m^2
Who cannot join
- suspected metastatic cervical or endometrial cancer
- prior abdominal surgery with postoperative complications
- active pancreatitis, obstruction of biliary tree or total bilirubin> 2.5 mg/dL
- active GI bleeding, or peptic ulcer disease
- unstable medical condition
- HbA1c >9.5 or uncontrolled diabetes
Show all 21Show fewer
- SBP >150 mmHg or DBP > 95 mmHg
- personal or familial contraindication to undergoing general anesthesia
- Antihypertensive agents or diabetic regimen that is not stable (4 weeks prior to surgery)
- taking CNS agents for pain
- acetaminophen or NSAIDs not discontinued for at least 5 half-lives prior to planned surgery
- currently taking an opioid or has taken an opioid chronically for pain in past 2 years
- corticosteroid or systemic corticosteroids within 6 weeks of planned surgery
- has a known bleeding disorder or taking agents affecting coagulation
- history of intolerance or allergic reactions to NSAIDs, COX-2 inhibitors, aspirin and other salicylates
- receiving lithium or a combination of furosemide with an ACE inhibitor or angiotensin receptor blocker
- Known to have sleep apnea
- History of hepatitis B or C
- AST or ALT > 2 times the upper limit of normal
- Known or suspected COPD with retention of carbon dioxide
- psychiatric condition that impairs the capability of the subject to report pain
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Poland7 sites
Study site
Bialystok, 15-276
Study site
Gdansk, 80-402
Study site
Lodz, 94-029
Study site
Lublin, 20-081
Study site
Poznan, 60-535
Study site
Ruda Śląska, 41-703
Study site
Szczecin, 70-111
Serbia3 sites
Study site
Belgrade, 11000
Study site
Kragujevac, 34000
Study site
Novi Sad, 21000
About this study
Official title: A Randomized Double-Blind, Placebo- and Active-Controlled, Dose-Ranging Study to Evaluate the Analgesic, Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Open Abdominal Hysterectomy
To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy
- Conditions
- Hysterectomy
- Being tested
- N1539, placebo, Morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1539Drug
5 mg IV once per day
N1539Drug
7.5 mg IV once per day
N1539Drug
15 mg IV once per day
N1539Drug
30 mg IV once per day
placeboDrug
IV placebo once per day
MorphineDrug
morphine 10-15 mg IV once per day
N1539Drug
60 mg IV once per day
| Study group | Role | What they receive |
|---|---|---|
| N1539 5 mg | Experimental | Not described Receives: Drug: N1539 |
| N1539 7.5 mg | Experimental | Not described Receives: Drug: N1539 |
| N1539 15 mg | Experimental | Not described Receives: Drug: N1539 |
| N1539 30 mg | Experimental | Not described Receives: Drug: N1539 |
| N1539 60 mg | Experimental | Not described Receives: Drug: N1539 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
| morphine | Active comparator | Not described Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours.
Additionally, to determine the efficacy seen within the first hour after study drug administration, as measured by the SPID 0-60 minutes post-dose.
Measured: at 60 minutes post dose and at 24 hours
Secondary outcomes (1)
To assess the safety and tolerability of IV N1539 by laboratory data, vital signs, wound site evaluation and Adverse Events
Measured: 5-7 days post initial dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alkermes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084161
- Sponsor's protocol ID
- N1539-04
- Status last verified
- Nov 2011
- First submitted
- 5 Mar 2010
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Rechberger T, Mack RJ, McCallum SW, Du W, Freyer A. Analgesic Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-Severe Pain After Open Abdominal Hysterectomy: A Phase 2 Randomized Clinical Trial. Anesth Analg. 2019 Jun;128(6):1309-1318. doi: 10.1213/ANE.0000000000003920.
PubMed 31094806Viscusi 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 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind, Placebo- and Active-Controlled, Dose-Ranging Study to Evaluate the Analgesic, Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Open Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT01084161
- Acronym / sponsor ID
- N1539-04
- Conditions
- Hysterectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Alkermes, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Mar 2010 (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.
To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| N1539 5 mg | Experimental | Drug: N1539 |
| N1539 7.5 mg | Experimental | Drug: N1539 |
| N1539 15 mg | Experimental | Drug: N1539 |
| N1539 30 mg | Experimental | Drug: N1539 |
| N1539 60 mg | Experimental | Drug: N1539 |
| Placebo | Placebo comparator | Drug: placebo |
| morphine | Active comparator | Drug: Morphine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- moderate to severe pain with VAS of >/= 45 mm
- undergo open abdominal hysterectomy
- ASA I or II
- signed ICF
- BMI >18.5 and < 31.5 kg/m^2
Key exclusion criteria (21 listed)
- suspected metastatic cervical or endometrial cancer
- prior abdominal surgery with postoperative complications
- active pancreatitis, obstruction of biliary tree or total bilirubin> 2.5 mg/dL
- active GI bleeding, or peptic ulcer disease
- unstable medical condition
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 |
|---|---|---|
| N15395 mg IV once per day | Drug | N1539 5 mg |
| N15397.5 mg IV once per day | Drug | N1539 7.5 mg |
| N153915 mg IV once per day | Drug | N1539 15 mg |
| N153930 mg IV once per day | Drug | N1539 30 mg |
| placeboIV placebo once per day | Drug | Placebo |
| Morphinemorphine 10-15 mg IV once per day | Drug | morphine |
| N153960 mg IV once per day | Drug | N1539 60 mg |
Primary outcome
To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours.
Time frame: at 60 minutes post dose and at 24 hours
Additionally, to determine the efficacy seen within the first hour after study drug administration, as measured by the SPID 0-60 minutes post-dose.
1 secondary outcome
To assess the safety and tolerability of IV N1539 by laboratory data, vital signs, wound site evaluation and Adverse Events
Time frame: 5-7 days post initial dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2011.
- Derived from this study: PubMed 31094806Rechberger T, Mack RJ, McCallum SW, Du W, Freyer A. Analgesic Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-Severe Pain After Open Abdominal Hysterectomy: A Phase 2 Randomized Clinical Trial. Anesth Analg. 2019 Jun;128(6):1309-1318. doi: 10.1213/ANE.0000000000003920.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N1539 and Morphine in people with Hysterectomy, run by Alkermes, Inc. at 12 sites in 3 countries.
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 5 inclusion and 21 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: finished, as of the sponsor's last update on 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Poland, Serbia, Georgia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours. (time frame: at 60 minutes post dose and at 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 NCT01084161, which also lists 2 linked publications.
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 2 Dec 2011.