A Phase 2 interventional study of DEX-IN and Fentanyl in Pain, sponsored by Baudax Bio. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Baudax Bio · Phase 2, Interventional, and Treatment
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Among 2,881 studies in Pain with a site in United States — 315 open to participants now, 393 under way, 24 of them phase 3. Pain · United States.
Among the 2,881 studies in Pain with a site in United States, this one is the 1,590th largest by enrollment of the 2,559 interventional ones that give a count, is one of 117 that started in 2017, is one of 341 in phase 2, and was the 1,790th registered.
10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.
Browse Pain studies →315 of the 2,881 studies in Pain with a site in United States are open now. Recruiting first, the newest first:
Yale University · Sites in United States
Ages 30–75
Vanderbilt University Medical Center · Sites in United States
Ages 18+
Columbia University · Sites in United States
Ages 6–17
Hospital for Special Surgery, New York · Sites in United States
Ages 18–80 · Healthy volunteers
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,881 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 249 · Phase 2 416 · Phase 3 374 · Phase 4 372
First in 1957; this study’s year is marked. 117 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 45 is below the median of 66 across 8,497 interventional studies indexed under Pain.
Median enrollment 66 across the 2,559 interventional studies, 99 across the 299 observational. Of the 2,224 that completed or were terminated, 1,051 (47%) have results posted.
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670 of 2,881 have an industry lead sponsor. The 10 most frequent:
Baudax Bio is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Baudax Bio has 9 studies filed under Pain — fewer than ten, so there is no comparison to draw.
171 of the studies in Pain with a site in United States that are under way reach primary completion within a year, 10 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07226258Phase 3Saol Therapeutics IncPhase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain | 2026-11-30 |
| NCT05964868Phase 3Jessyka LighthallEfficacy of Liposomal Bupivacaine Post Septorhinoplasty | 2026-12 |
| NCT07832552Phase 3Harrow IncA Phase 3 Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery | 2026-12 |
| NCT03823534Phase 3St. Louis UniversityPost-Op Pain Control for Prophylactic Intramedullary Nailing. | 2026-12-31 |
| NCT07276542Phase 3The Ketamine Research FoundationClinical Trial Exploring the Outpatient Treatment of Phantom Limb Pain With Ketamine Administration in a Six Month Study With a Minimum Remission Period of 7 Days Between Treatment Session. 25-30 Subjects With an Ongoing History of Significant PLP.--FDA and IRB Approved. | 2026-12-31 |
Add all 171 to your calendar (.ics) → With an account.
Among the 2,881 studies in Pain with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared with placebo and active control (fentanyl), in subjects undergoing painful outpatient and office based procedures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dexmedetomidine Intranasal Spray
Drug: DEX-IN
Intravenous Fentanyl
Drug: Fentanyl
Placebo
Drug: Placebo
IN Dexmedetomidine + IV placebo
IN Placebo + IV Fentanyl
IN Placebo + IV Placebo
Evaluation of Pain Intensity - Mean Pain Score During Procedure
Evaluation of subject reported pain intensity scores according to the 11-point Numeric Pain Rating Scale (NPRS; 0-10)
Time frame: Up to 4 Hours
| Milestone | DEX-IN 50 µg | Fentanyl 50 µg | Placebo |
|---|---|---|---|
| Started | 15 | 15 | 15 |
| Completed | 15 | 15 | 15 |
| Not completed | 0 | 0 | 0 |
Evaluation of subject reported pain intensity scores according to the 11-point Numeric Pain Rating Scale (NPRS; 0-10)
| units on a scale | DEX-IN 50 µg | Fentanyl 50 µg | Placebo |
|---|---|---|---|
| Evaluation of Pain Intensity - Mean Pain Score During Procedure | 3.03 ± 0 | 3.10 ± 0 | 4.25 ± 0 |
Collected over 7 Days. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DEX-IN 50 µg | 0/15 (0%) | 0/15 (0%) | 5/15 (33.3%) |
| Fentanyl 50 µg | 0/15 (0%) | 0/15 (0%) | 2/15 (13.3%) |
| Placebo | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Event | DEX-IN 50 µg | Fentanyl 50 µg | Placebo |
|---|---|---|---|
| Blood pressure decreaseInvestigations | 3/15 | 1/15 | 0/15 |
| DizzinessNervous system disorders | 0/15 | 1/15 | 0/15 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 1/15 | 0/15 | 0/15 |
| HypotensionVascular disorders | 1/15 | 1/15 | 0/15 |
All randomized subjects
| Age, Continuous(years) | DEX-IN 50 µg | Fentanyl 50 µg | Placebo | Total |
|---|---|---|---|---|
| Mean | 39.5 ± 12.76 | 47.2 ± 9.78 | 46.8 ± 10.31 | 44.5 ± 11.35 |
| Sex: Female, Male(Participants) | DEX-IN 50 µg | Fentanyl 50 µg | Placebo | Total |
|---|---|---|---|---|
| Female | 13 | 13 | 14 | 40 |
| Male | 2 | 2 | 1 | 5 |
| Race (NIH/OMB)(Participants) | DEX-IN 50 µg | Fentanyl 50 µg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 0 | 2 |
| White | 12 | 15 | 13 | 40 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 | 2 |
| Region of Enrollment(participants) | DEX-IN 50 µg | Fentanyl 50 µg | Placebo | Total |
|---|---|---|---|---|
| United States | 15 | 15 | 15 | 45 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Nov 2017 to primary completion in Jan 2018, 2 months.
Results were first posted in May 2023, 5 years 4 months after primary completion.
Of 62 industry-sponsored phase 2 interventional studies under Pain, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's 2 months is below that.
Counting every sponsor, half of 186 studies reached it within 21 months; a quarter within 7 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Baudax Bio