Pain, PostoperativePhase 3NCT05324358
Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy
A Phase 3 study testing Ketorolac Tromethamine and Morphine Sulfate in people with Pain, Postoperative, run by Neumentum, Inc. at 10 sites in United States.
Trial summary
This clinical study is a randomized, double-blind, double-dummy, parallel group, multi-center, active and placebo-controlled trial evaluating the analgesic efficacy and safety of NTM-001 in subjects with moderately severe postoperative pain after bunionectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ketorolac Tromethamine and Morphine Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 341 participants
- Where
- 10 sitesUnited States
- Study dates
- 14 Dec 2022to May 2027
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent obtained prior to any study-related procedure being performed.
- Male or female subjects between 18 and <65 years of age at time of consent.
- Body weight ≥50 kg.
- Physical status rated as ≤2 on the American Society of Anesthesiologists (ASA) rating scale (Owens, Felts et al. 1978).
- Scheduled to undergo primary unilateral first metatarsal bunionectomy.
- Women must be postmenopausal, surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control if they are sexually active before entry, throughout the study, and for 7 days after the last dose of study drug (effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier method, and male partner sterilization). Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and a negative urine pregnancy test before surgery.
- Subject is willing and able to complete all study procedures including training on pain scales, follow instructions, communicate meaningfully with study personnel, and return for all visits as listed in the protocol.
Who cannot join
- History of peptic ulcer disease, GI bleeding, perforation, or active peptic ulcer disease.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- History of, or suspected or confirmed, cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis.
- Increased risk of bleeding at the discretion of the Investigator based on prior/concomitant disease, laboratory values, medication or surgical complications.
- Clinical laboratory values reflecting at least mild renal insufficiency as indicated by a creatinine clearance ≤89 mL/min.
- Risk for renal failure due to volume depletion at the discretion of the Investigator.
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- Concomitant use of aspirin or NSAIDs.
- History of seizure disorder or epilepsy, as suggested by the presence of any of the following:
- Mild or moderate traumatic brain injury, stroke, transient ischemic attach, or brain neoplasm within 1 year of screening.
- Severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration, or posttraumatic amnesia of more than 24 hours duration within 15 years of screening.
- History of alcohol or drug abuse in the Investigator's judgement based on subject history and physical examination.
- Significant chronic obstructive pulmonary disease or cor pulmonale, a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression.
- At least moderately impaired hepatic function (Child-Pugh >6), or subjects with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values greater than 3 times the upper limit of normal (ULN).
- Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days.
- The subject is not on a stable dose (at least 2 weeks prior to Screening Visit) of medications that may lower the seizure threshold (e.g., anti-psychotic agents) or which impact the serotonergic system (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants).
- Evidence of significant anemia (indicated by hemoglobin concentration ≤8 g/dL).
- Evidence of active infections that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of the hip, Hepatitis B or C, or other overt infections) or a history of human immunodeficiency virus (HIV) 1 or 2.
- History of malignancy within 2 years prior to the start of the study, with the exception of basal cell and cutaneous squamous cell carcinoma.
- History of systemic lupus erythematosus, antiphospholipid syndrome, vasculitis, vasculopathy, or deep vein thrombosis.
- Uncontrolled or poorly controlled post-traumatic stress disorder, generalized anxiety disorder, depression, psychiatric, or other significant medical conditions.
- Chronic systemic steroid therapy, excluding inhalers or a 1-time intraoperative dose, within 4 weeks before screening.
- History of pending litigation due to pain or disability.
- Clinically significant disease that, in the Investigator's opinion, may affect efficacy or safety assessments.
- Employees of the Investigator or study site with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, including family members of the employees or the Investigator.
- Received an experimental drug or used an experimental medical device within 30 days before screening or have participated in a previous study of ketorolac.
- Contraindications to, or history of allergy or hypersensitivity to ketorolac and/or morphine and their excipients.
- A positive COVID-19 test (rapid antigen test) or COVID-19 related symptoms at screening and/or at check in of Visit 2 (Surgical Period).
- Subjects who are planning on receiving a COVID-19 vaccine during the study duration.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Trovare Clinical Research
Bakersfield, California, 93301
Alliance Research Intitute
Canoga Park, California, 91304
Midwest Clinical Research Center
Dayton, Ohio, 45417
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
Chesapeake Research
Pasadena, Maryland, 21122
Pasadena Clinical Trials
Pomona, California, 91767
Endeavor Clinical Trials
San Antonio, Texas, 78229
Sun City Clinical Research
Sun City, Arizona, 85351
The Orthopedic Center
Tulsa, Oklahoma, 74104
Curalta Clinical Trials
Westwood, New Jersey, 07675
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Active and Placebo-Controlled Trial to Evaluate the Analgesic Efficacy and Safety of NTM-001 for the Treatment of Moderately Severe Postoperative Pain Following Bunionectomy
This clinical study is a randomized, double-blind, double-dummy, parallel group, multi-center, active and placebo-controlled trial evaluating the analgesic efficacy and safety of NTM-001 in subjects with moderately severe postoperative pain after bunionectomy surgery.
This study is designed to compare the efficacy of NTM-001 to placebo. Intravenous (IV) morphine serves as an active comparator to determine assay sensitivity and support assessment of opioid-level analgesia for NTM-001. Effectiveness, safety, and tolerability parameters will be descriptively compared between treatment arms.
- Conditions
- Pain, Postoperative
- Being tested
- Ketorolac Tromethamine, Morphine Sulfate, Intravenous Placebo for NTM-001, IV Placebo for Morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Also called NTM-001 (Ketorolac Tromethamine IV Continuous Infusion)
Ketorolac tromethamine, alcohol free formulation, 1.0 mg/mL in saline solution (~0.9% NaCl) adjusted to a pH of ~7.4. Contained in a sterile, 200 mL polyolefin bag (filled with 125 mL of NTM-001).
Morphine SulfateDrug
Also called Morphine Sulfate Injection USP
Morphine single use vials at 4 mg/mL, filled with 1 mL.
Intravenous Placebo for NTM-001Other
Placebo alcohol free saline solution (~0.9% NaCl; matching active NTM-001). Contained in a sterile, 200 mL polyolefin bag (filled with 125 mL Placebo solution).
IV Placebo for MorphineOther
Placebo single use vials with saline (matching active morphine).
| Study group | Role | What they receive |
|---|---|---|
| NTM-001 Treatment Arm | Experimental | * NTM-001 loading dose of 12.5 mg administered over approximately 60 seconds, followed by a continuous IV infusion at a rate of 3.5 mg/h for 24h, by a pre-programmed infusion pump.
* Subjects will also receive placebo to IV Morphine (injections). Receives: Drug: Ketorolac Tromethamine; Other: IV Placebo for Morphine |
| Morphine Treatment Arm | Active comparator | * A single IV morphine bolus (4 mg) every 4h for up to 24h.
* Subjects will also receive placebo to NTM-001. Receives: Drug: Morphine Sulfate; Other: Intravenous Placebo for NTM-001 |
| Placebo Treatment Arm | Placebo comparator | Subjects randomized will receive placebos of both active treatments concomitantly.
* Placebo to NTM-001: Placebo "loading dose" applied over approximately 60 seconds, followed by a continuous IV infusion at a rate of 3.5 mL/h for 24h by a pre-programmed infusion pump.
* Placebo to IV morphine injections: A single IV placebo bolus every 4h for up to 24h. Receives: Other: Intravenous Placebo for NTM-001; Other: IV Placebo for Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Pain Intensity Difference (SPID24)
The primary endpoint is the Summed Pain Intensity Difference over 24h (SPID24) from start to end of administration of investigational medicinal product (IMP). Calculated as the weighted sum of the PID (difference between baseline at qualifying period and current pain intensity) collected at protocol scheduled time points through up to 24h after starting infusion of the IMP, using the following formula: SPID24 = Σ Wi * PIDi (1) where the Σ sums over all observations collected from the first assessment after the first IMP administration to Hour 24 and Wi is the time elapsed from the previous observation PIDi-1 to the current observation PIDi.
Measured: 0 to 24 hours after start of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start14 Dec 2022
- Primary completion6 Sep 2024
- Study completionMay 2027 (estimated)
Why it stopped: Study activities were suspended due to funding constraints after enrollment completion (N=340). Remaining activities, including data cleaning, database lock, analysis, and reporting, will resume once funding is secured.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neumentum, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- NEMA Research, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324358
- Sponsor's protocol ID
- NTM-001-CT001
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Active and Placebo-Controlled Trial to Evaluate the Analgesic Efficacy and Safety of NTM-001 for the Treatment of Moderately Severe Postoperative Pain Following Bunionectomy
- ClinicalTrials.gov ID
- NCT05324358
- Acronym / sponsor ID
- NTM-001-CT001
- Conditions
- Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study activities were suspended due to funding constraints after enrollment completion (N=340). Remaining activities, including data cleaning, database lock, analysis, and reporting, will resume once funding is secured.
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Neumentum, Inc.University, hospital or other
- Collaborators
- NEMA Research, Inc.
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 12 Apr 2022 (actual)
- 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.
This clinical study is a randomized, double-blind, double-dummy, parallel group, multi-center, active and placebo-controlled trial evaluating the analgesic efficacy and safety of NTM-001 in subjects with moderately severe postoperative pain after bunionectomy surgery.
This study is designed to compare the efficacy of NTM-001 to placebo. Intravenous (IV) morphine serves as an active comparator to determine assay sensitivity and support assessment of opioid-level analgesia for NTM-001. Effectiveness, safety, and tolerability parameters will be descriptively compared between treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NTM-001 Treatment Arm | Experimental | Drug: Ketorolac Tromethamine, Other: IV Placebo for Morphine* NTM-001 loading dose of 12.5 mg administered over approximately 60 seconds, followed by a continuous IV infusion at a rate of 3.5 mg/h for 24h, by a pre-programmed infusion pump. * Subjects will also receive placebo to IV Morphine (injections). |
| Morphine Treatment Arm | Active comparator | Drug: Morphine Sulfate, Other: Intravenous Placebo for NTM-001* A single IV morphine bolus (4 mg) every 4h for up to 24h. * Subjects will also receive placebo to NTM-001. |
| Placebo Treatment Arm | Placebo comparator | Other: Intravenous Placebo for NTM-001, Other: IV Placebo for MorphineSubjects randomized will receive placebos of both active treatments concomitantly. * Placebo to NTM-001: Placebo "loading dose" applied over approximately 60 seconds, followed by a continuous IV infusion at a rate of 3.5 mL/h for 24h by a pre-programmed infusion pump. * Placebo to IV morphine injections: A single IV placebo bolus every 4h for up to 24h. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent obtained prior to any study-related procedure being performed.
- Male or female subjects between 18 and <65 years of age at time of consent.
- Body weight ≥50 kg.
- Physical status rated as ≤2 on the American Society of Anesthesiologists (ASA) rating scale (Owens, Felts et al. 1978).
- Scheduled to undergo primary unilateral first metatarsal bunionectomy.
Key exclusion criteria (28 listed)
- History of peptic ulcer disease, GI bleeding, perforation, or active peptic ulcer disease.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
- History of, or suspected or confirmed, cerebrovascular bleeding, hemorrhagic diathesis, or incomplete hemostasis.
- Increased risk of bleeding at the discretion of the Investigator based on prior/concomitant disease, laboratory values, medication or surgical complications.
- Clinical laboratory values reflecting at least mild renal insufficiency as indicated by a creatinine clearance ≤89 mL/min.
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 |
|---|---|---|
| Ketorolac TromethamineAlso: NTM-001 (Ketorolac Tromethamine IV Continuous Infusion)Ketorolac tromethamine, alcohol free formulation, 1.0 mg/mL in saline solution (~0.9% NaCl) adjusted to a pH of ~7.4. Contained in a sterile, 200 mL polyolefin bag (filled with 125 mL of NTM-001). | Drug | NTM-001 Treatment Arm |
| Morphine SulfateAlso: Morphine Sulfate Injection USPMorphine single use vials at 4 mg/mL, filled with 1 mL. | Drug | Morphine Treatment Arm |
| Intravenous Placebo for NTM-001Placebo alcohol free saline solution (~0.9% NaCl; matching active NTM-001). Contained in a sterile, 200 mL polyolefin bag (filled with 125 mL Placebo solution). | Other | Morphine Treatment Arm, Placebo Treatment Arm |
| IV Placebo for MorphinePlacebo single use vials with saline (matching active morphine). | Other | NTM-001 Treatment Arm, Placebo Treatment Arm |
Primary outcome
Summed Pain Intensity Difference (SPID24)
Time frame: 0 to 24 hours after start of administration
The primary endpoint is the Summed Pain Intensity Difference over 24h (SPID24) from start to end of administration of investigational medicinal product (IMP). Calculated as the weighted sum of the PID (difference between baseline at qualifying period and current pain intensity) collected at protocol scheduled time points through up to 24h after starting infusion of the IMP, using the following formula: SPID24 = Σ Wi * PIDi (1) where the Σ sums over all observations collected from the first assessment after the first IMP administration to Hour 24 and Wi is the time elapsed from the previous observation PIDi-1 to the current observation PIDi.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac Tromethamine and Morphine Sulfate in people with Pain, Postoperative, run by Neumentum, Inc. at 10 sites 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 7 inclusion and 28 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: paused, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
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?
Summed Pain Intensity Difference (SPID24) (time frame: 0 to 24 hours after start of administration). 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 23 Apr 2026.