Last reviewed · How we verify
NCT02746263
Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain
Phase 4 trial testing IV acetaminophen in Acute Pain, Postoperative in 1 participant. Terminated before completion.
5 May 2016
Quick facts
| Lead sponsor | Mallinckrodt |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 27 April 2016 |
| Primary completion | 5 May 2016 |
| Estimated completion | 5 May 2016 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- IV acetaminophen — full drug profile →
- Oral acetaminophen
- Morphine
Conditions studied
- Acute Pain, Postoperative — all drugs for Acute Pain, Postoperative →
Sponsor
Mallinckrodt — full company profile →
Who can join
Adults 50 to 90, any sex, with Acute Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: 9 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other adverse events (9 terms — click to expand)
| Reaction | System | IV Acetaminophen/Morphine | Oral Acetaminophen/Morphine |
|---|---|---|---|
| Acute blood loss anemia | Blood and lymphatic system disorders | — | — |
| Diffuse bronchial wall thickening | Respiratory, thoracic and mediastinal disorders | — | — |
| Intermittent thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Intermittent leucocytosis | Blood and lymphatic system disorders | — | — |
| Persistent sinus tachycardia | Cardiac disorders | — | — |
| Postoperative pain | General disorders | — | — |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | — | — |
| Stress hyperglycemia | Endocrine disorders | — | — |
| Suspicion of adrenal insufficiency | Endocrine disorders | — | — |
Data from ClinicalTrials.gov NCT02746263 adverse events section.
Sponsor's own description
The purpose of this study is to compare intravenous (IV) and oral acetaminophen for the treatment of acute moderate to severe pain in combination with standard patient-controlled analgesia (PCA) in adult subjects following total knee replacement.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02746263
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of IV acetaminophen
Trials testing the same drug.
- NCT04933058 — Opioid Based Analgesia vs Non-opioid Analgesia for Oocyte Retrieval Procedure · NA · completed
- NCT04093219 — PANDORA: Delirium Prevention After Cardiac Surgery Using IV Acetaminophen to Prevent Postoperative Delirium in Older Car · Phase 3 · completed
- NCT03553498 — IV Acetaminophen as Adjuvant Analgesic to Hydromorphone - Emergency Department Patients · Phase 3 · completed
- NCT03062488 — Emergence Agitation and Pain Scores in Pediatrics When Comparing Single-modal vs Multi-modal Analgesia for ENT Surgery · EARLY_PHASE1 · completed
- NCT02549716 — Clinical, Pharmacological and Molecular Effects of IV and Oral Acetaminophen in Adults With aSAH · Phase 4 · terminated
Other recruiting trials for Acute Pain, Postoperative
Currently open trials in the same condition.
- NCT07336264 — Characterization of Acute Pain · recruiting
Other Mallinckrodt trials
Trials by the same sponsor.
- NCT04169061 — Impact of Acthar on Everyday Life of Participants With Severe Keratitis · Phase 4 · completed
- NCT03712280 — MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy) · Phase 2 · completed
- NCT03656692 — Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer) · Phase 4 · terminated
- NCT03320070 — Acthar Gel in Participants With Pulmonary Sarcoidosis · Phase 4 · completed
- NCT03132428 — Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02746263 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mallinckrodt
- Last refreshed: 19 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02746263.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing