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NCT04651361
Naldebain for Pain Control After Bariatric Surgery
Phase 2, PHASE3 trial testing Dinalbuphine sebacate in Pain, Postoperative in 60 participants. Status unknown.
31 March 2022
Quick facts
| Lead sponsor | E-DA Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 24 June 2021 |
| Primary completion | 31 March 2022 |
| Estimated completion | 30 June 2022 |
| Sites | 2 locations across Taiwan |
Drugs / interventions tested
- Dinalbuphine sebacate — full drug profile →
- Placebo solution
Conditions studied
- Pain, Postoperative — all drugs for Pain, Postoperative →
- Pain, Chronic — all drugs for Pain, Chronic →
- Bariatric Surgery — all drugs for Bariatric Surgery →
- Obesity — all drugs for Obesity →
Sponsor
E-DA Hospital
Who can join
Adults 20 to 65, any sex, with Pain, Postoperative or Pain, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Laparoscopic gastric sleeve and bypass surgeries the most common bariatric procedures for weight loss and improved management of metabolic syndromes. Patients may suffer from wound pain or referred pain after laparoscopic bariatric operation. Most importantly, 11.8% of these patients complained surgical-related pain one year after operation, and 8% of them required prolonged use of opioid to control chronic postoperative pain (CPSP). However, there are currently lack of clinical practice guidelines or recommendations for prevention of CPSP after laparoscopic abdominal surgery. Although regional block techniques (i.e. truncal block or intrathecal opioid) are considered as effective supplementary analgesic approaches to improve postoperative pain control, parenteral administration of analgesics remain as the mainstay for pain management of laparoscopic abdominal surgery. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is an extended-release dinalbuphine sebacate, and is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. A number of clinical studies have shown that single-dose of pre-operative intramuscular administration of Naldebain® provides significantly higher analgesic effect up to 1 week in hemorrhoidectomy and laparotomy surgery with a well-tolerated safety profile. Therefore, this PI-initiated randomized, double-blind, placebo-control trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in patients receiving laparoscopic gastric sleeve or bypass surgery, and prevention of the development of CPSP after surgery. This study will also analyze the plasma levels of nalbuphine following a single intramuscular injection in obese patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04651361
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Other E-DA Hospital trials
Trials by the same sponsor.
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- NCT06460402 — Ice Therapy and Warm Baths for Hemorrhoidectomy Wound Care · NA · enrolling by invitation
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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 NCT04651361 (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 E-DA Hospital
- Last refreshed: 28 December 2021
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/NCT04651361.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing