Overview
Sponsor-declared trial summary
Postmastectomy Syndrome
To determine the effectiveness of Botulinum Toxin type A and topical Capsaicin for the treatment of moderate-severe pain in PMS among women who underwent surgery for unilateral breast neoplasia.
Key facts
- Sponsor
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]
- Trial duration
- 10 Mar 2025 → ongoing
- Decision date (initial)
- 2024-09-04
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merz Therapeutics · Fundacion FISABIO · Hospital Universitario Doctor Peset
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To determine the effectiveness of Botulinum Toxin type A and topical Capsaicin for the treatment of moderate-severe pain in PMS among women who underwent surgery for unilateral breast neoplasia.
Secondary objectives 2
- To discriminate other factors associated with pain that may influence the therapeutic response.
- Recording of the degree of patient satisfaction
Conditions and MedDRA coding
Postmastectomy Syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10088494 | Postmastectomy pain syndrome | 100000004848 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-513609-29-00 | Prospective, randomized, blinded, comparative study between botulinum toxin and topical capsaicin in the treatment of postmastectomy syndrome. Pilot study | Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Women over 18 years of age operated on for unilateral breast neoplasia
- Patients with painful symptoms defining postmastectomy syndrome.
- Patients with moderate-severe pain.
- Signed informed consent form.
Exclusion criteria 5
- Age less than 18 years
- Presence of cognitive-behavioral deficits.
- Patients with bilateral tumor involvement, cases of tumor recurrence, patients referred for non-oncologic breast surgery.
- Non-acceptance to participate in the study.
- Breast tumors in men.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Pain assessment: Recording of pain intensity using a visual analogue scale (VAS)
- Characterization of the predominant pain perception: burning, stabbing pain, sensation of pressure or numbness.
Secondary endpoints 3
- Recording of side effects
- Recording of the degree of patient satisfaction
- Recording of concomitant analgesic medications
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
XEOMIN 100 unidades polvo para solución inyectable
PRD10941712 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Substance synonyms
- IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kD), free from complexing proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 100 U unit(s)
- Max total dose
- 100 U unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 69292
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Qutenza 179 mg cutaneous patch
PRD4980580 · Product
- Active substance
- Capsaicin
- Pharmaceutical form
- CUTANEOUS PATCH
- Route of administration
- TRANSDERMAL USE
- Max daily dose
- 179 mg milligram(s)
- Max total dose
- 179 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BX04 — CAPSAICIN
- Marketing authorisation
- EU/1/09/524/001
- MA holder
- GRÜNENTHAL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Sponsor organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Address
- Avenida Cataluna No 21
- City
- Valencia
- Postcode
- 46020
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Contact name
- M Rosario Beseler Soto
Public contact point
- Organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Contact name
- M Rosario Beseler Soto
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-03-10 | 2025-03-10 | 2025-12-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocolo_2024-513609-29_ForPublic | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment Arrangememts | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2024-513609-29 | 2 |
| Synopsis of the protocol (for publication) | D1_Sinopsis protocolo_2024-513609-29 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-26 | Spain | Acceptable 2024-09-04
|
2024-09-04 |