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NCT06606067: GENDOLCAT3
Duloxetine to Prevent Chronic Postsurgical Pain After Inguinal Hernia Repair in Patients at High Risk
Phase 3 trial testing Duloxetine in Chronic Post-surgical Pain in 294 participants. Participants enrolled and being followed up; not accepting new ones.
31 July 2026
Quick facts
| Lead sponsor | Parc de Salut Mar |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 294 |
| Start date | 3 September 2024 |
| Primary completion | 31 July 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Duloxetine (duloxetine) — full drug profile →
- Placebo
Conditions studied
- Chronic Post-surgical Pain — all drugs for Chronic Post-surgical Pain →
Sponsor
Parc de Salut Mar — full company profile →
Who can join
18 and older, male only, with Chronic Post-surgical Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The clinical trial will be conducted in 14 Spanish hospitals. It is estimated, based on our previous studies, that 2855 patients scheduled for elective inguinal hernia surgery will have to be assessed to detect patients with ≥ 27% level of risk for Chronic Post-Surgical Pain (CPSP). These high-risk patients will be randomized to 2 treatment groups: one will receive duloxetine for 2 weeks prior to surgery and 1 week after surgery (intervention group) and the other the placebo (control group) during the same periods. The primary outcome will be a ≥ 50% decrease in the CPSP incidence in the intervention group compared to the placebo group, 4 months after surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06606067
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT06711978 — Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a R · NA · not yet recruiting
Other recruiting trials for Chronic Post-surgical Pain
Currently open trials in the same condition.
- NCT06344169 — Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section · Phase 2, PHASE3 · recruiting
- NCT05920382 — Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain. · NA · recruiting
- NCT05304286 — Psychophysical and Neural Mechanisms Contributing to Chronic Post-Surgical Pain in Adolescents and Adults · NA · recruiting
Other Parc de Salut Mar trials
Trials by the same sponsor.
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- NCT07223450 — A Study on Oral and Intranasal Forms of Oxycodone in Healthy Volunteers Using Pharmacokinetic Modeling · Phase 1 · completed
- NCT07504913 — Spanish Validation of KOQUSS-40 Questionnaire: Assessing QoL of Gastric Cancer Patients After Gastrectomy: SPQUSS-41 · recruiting
- NCT06806072 — BALNEOTHERAPY FOR BREAST CANCER PATIENTS UNDERGOING ENDOCRINE THERAPY · NA · not yet recruiting
- NCT04084795 — Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia · NA · recruiting
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 NCT06606067 (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 Parc de Salut Mar
- Last refreshed: 20 September 2024
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/NCT06606067.
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