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NCT03246971
Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain
Phase 2 trial testing Wafermine™ 50 mg in Acute Pain in 125 participants. Completed in 17 July 2018.
12 July 2018
Quick facts
| Lead sponsor | iX Biopharma Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 125 |
| Start date | 24 August 2017 |
| Primary completion | 12 July 2018 |
| Estimated completion | 17 July 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Wafermine™ 50 mg — full drug profile →
- Wafermine™ 75 mg — full drug profile →
- Placebos — full drug profile →
- Wafermine™ 25 mg — full drug profile →
Conditions studied
- Acute Pain — all drugs for Acute Pain →
- Bunion — all drugs for Bunion →
- Abdominoplasty — all drugs for Abdominoplasty →
Sponsor
iX Biopharma Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Acute Pain or Bunion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of 4 subjects will receive placebo.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Abdominoplasty as an acute postoperative pain model: insights from 8 years of clinical trials.
Singla N, Singla N, Rogier T. · · 2023 · cited 6× · PMID 35947083 · DOI 10.1097/j.pain.0000000000002736
Verify or expand the search:
- PubMed search for NCT03246971
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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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 NCT03246971 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by iX Biopharma Ltd.
- Last refreshed: 23 July 2018
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/NCT03246971.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing