CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Postmastectomy pain syndrome

Inclusion criteria

• {"criterion_text":"- Women over 18 years of age operated on for unilateral breast neoplasia\n- Patients with painful symptoms defining postmastectomy syndrome.\n- Patients with moderate-severe pain.\n- Signed informed consent form."}

Exclusion criteria

• {"criterion_text":"- Age less than 18 years\n- Presence of cognitive-behavioral deficits.\n- Patients with bilateral tumor involvement, cases of tumor recurrence, patients referred for non-oncologic breast surgery.\n- Non-acceptance to participate in the study.\n- Breast tumors in men."}

Primary endpoints

• {"endpoint_text":"- Pain assessment: Recording of pain intensity using a visual analogue scale (VAS)","definition_or_measurement_approach":"Recording of pain intensity using a visual analogue scale (VAS)."}
• {"endpoint_text":"- Characterization of the predominant pain perception: burning, stabbing pain, sensation of pressure or numbness.","definition_or_measurement_approach":"Characterisation of the predominant pain perception as burning, stabbing pain, sensation of pressure or numbness (as recorded in study assessments)."}

Secondary endpoints

• {"endpoint_text":"- Recording of side effects","definition_or_measurement_approach":"Recording and reporting of adverse events/side effects."}
• {"endpoint_text":"- Recording of the degree of patient satisfaction","definition_or_measurement_approach":"Recording of patient satisfaction (degree) as per study assessments."}
• {"endpoint_text":"- Recording of concomitant analgesic medications","definition_or_measurement_approach":"Recording of concomitant analgesic medication use."}

Spain

Earliest CTIS Part Ii Submission Date

02-08-2024

Latest Decision Or Authorization Date

04-09-2024

Processing Time Days

33

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Merz Therapeutics","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Hospital Universitario Doctor Peset","duties_or_roles":"Monetary support","organisation_type":""}