Condition (MeSH)
Breakthrough Pain
ClinicalTrials.gov lists 33 trials for Breakthrough Pain or a narrower condition beneath it. Cephalon has the most among industry and government lead sponsors, with 6.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
Trials per phase
33 of the 33 trials are tagged with Breakthrough Pain itself; the rest are tagged with a narrower condition beneath it.
When did Breakthrough Pain trials start? (19)
Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Trials over time, by phase
- Phase 1
- Phase 1/2
- Phase 2
- Phase 3
- Phase 4
- Not applicable
- Observational
Top of scale: 3
Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.
| Year | Trials started |
|---|---|
| 2026 (partial year) | 1 |
| 2025 | 2 |
| 2024 | 2 |
| 2022 | 2 |
| 2021 | 1 |
| 2020 | 2 |
| 2017 | 1 |
| 2016 | 3 |
| 2015 | 3 |
| 2013 | 1 |
Showing 10 of 19 earlier years.
No forecast is made for this condition: it averages 1.4 trial starts a year over the five years to September, under the 5 a year the method needs.
Recruitment duration, a model prediction: 4 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
What phase are Breakthrough Pain trials in? (7)
Shown in this order: phase order.
Show the trials by phase as a table
| Phase | Trials |
|---|---|
| Phase 1 | 3 |
| Phase 1/2 | 1 |
| Phase 2 | 2 |
| Phase 3 | 9 |
| Phase 4 | 5 |
| Not applicable | 3 |
| Observational | 10 |
How many Breakthrough Pain trials are recruiting? (7)
Shown in this order: the order a trial moves through, from not yet recruiting to unknown.
| Status | Trials |
|---|---|
| Not yet recruiting | 1 |
| Recruiting | 3 |
| Active, not recruiting | 3 |
| Completed | 19 |
| Terminated | 4 |
Showing 5 of 7 statuses.
Status as registered on ClinicalTrials.gov. Each trial is counted once.
Which lead sponsors run the most Breakthrough Pain trials? (7)
Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.
| Sponsor | Trials |
|---|---|
| Cephalon | 6 |
| Angelini Farmacéutica | 3 |
| KK Women's and Children's Hospital | 2 |
| Kyowa Kirin Co., Ltd. | 2 |
| Department of Medical Services Ministry of Public Health of Thailand | 1 |
Showing 5 of 7 sponsors.
Which drugs are being tested for Breakthrough Pain? (1)
Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.
| Drug | Trials |
|---|---|
| FENTANYL | 14 |
Interventions as named in the registry (14)
Shown in this order: most trials first.
| Drug | Trials |
|---|---|
| Ropivacaine 2 % | 2 |
| PO Morphine | 2 |
| programmed intermittent Bolus epidural analgesia | 2 |
| continuous epidural infusion | 2 |
| Tramadol /acetaminophen | 1 |
Showing 5 of 14 interventions.
These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.
Which serious adverse events do Breakthrough Pain trials report? (10)
Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.
| Adverse event | Subjects affected | Trials |
|---|---|---|
| Malignant neoplasm progression | 21 | 1 |
| death | 19 | 1 |
| Death | 18 | 1 |
| Dehydration | 8 | 3 |
| Prostate cancer metastatic | 6 | 2 |
Showing 5 of 10 adverse events.
Which publications cover Breakthrough Pain? (42)
Shown in this order: major-topic papers first, then newest, then most linked to trials.
| Publication | Journal | Year | Major topic |
|---|---|---|---|
| Characterizing patterns of sensory loss during labor epidural analgesia: a prospective study of breakthrough pain. | International journal of obstetric anesthesia | 2025 | Yes |
| Efficacy and safety of fentanyl inhalant for the treatment of breakthrough cancer pain: a multicenter, randomized, double-blind, placebo-controlled trial. | BMC palliative care | 2024 | Yes |
| Effectiveness of fentanyl buccal soluble film in cancer patients with inadequate breakthrough pain control. | BMC palliative care | 2024 | Yes |
| Efficacy of reconstituted intravenous fentanyl to sublingual solution versus oral morphine syrup for breakthrough pain among patients with chronic gynecologic cancer pain: A randomized, double-blind, placebo-controlled trial. | The journal of obstetrics and gynaecology research | 2023 | Yes |
| Automated mandatory bolus versus basal infusion for maintenance of epidural analgesia in labour. | The Cochrane database of systematic reviews | 2023 | Yes |
Showing 5 of 42 publications.
Not on this page
Not measured: delivery record.
Checked, with nothing recorded for this condition: prevalence, rare-disease identity, and sub-conditions in mesh.