Triamcinolone Hexacetonide for Carpal tunnel syndrome

Inclusion criteria

• {"criterion_text":"- Adult (≥18 years of age)"}
• {"criterion_text":"- Patient history indicating CTS (see section 2.2.1 in protocol)"}
• {"criterion_text":"- Neurophysiological examination performed within 6 months"}
• {"criterion_text":"- Diagnosis of CTS based on: a. Classic/probable or possible symptoms, and neurophysiological findings consistent with CTS Or, in case of normal neurophysiological findings: b. Classic/probable symptoms and positive physical exam findings and/or nighttime symptoms"}
• {"criterion_text":"- Mild to moderate symptoms (intermittent, interfering with everyday life, and/or disturb sleep)"}

Exclusion criteria

• {"criterion_text":"- Previous CTS surgery or corticosteroid injection in the carpal tunnel in the relevant hand"}
• {"criterion_text":"- Inadequate birth control (Only applicable for women of childbearing potential. Refer to protocol section 10.4 for definitions and contraception guidance), pregnancy (Only applicable for women of childbearing potential. Refer toprotocol section 8.3.5.), and/or breastfeeding (current at screening or planned within the duration of the study)"}
• {"criterion_text":"- Known hypersensitivity to the interventional drug (Triamcinolone Hexacetonide (Lederspan) or Triamcinolone Acetonide (Kenacort-T)), or any of the excipients (sorbitol, polysorbate or benzyl alcohol)"}
• {"criterion_text":"- Concomitant therapy with CYP3A-inhibitors or digitalis glycosides"}
• {"criterion_text":"- Patients vaccinated or immunized with live virus vaccines within 2 weeks of treatment"}
• {"criterion_text":"- Alcohol or other substance abuse"}
• {"criterion_text":"- Language barriers"}
• {"criterion_text":"- Other factors which make adherence to study protocol impossible"}
• {"criterion_text":"- Diagnosis of severe CTS, based on history and examination indicating severe CTS with constant symptoms including pain, loss of sensibility, dexterity or reduced temperature sensation, weakness of thumb abduction and opposition, or atrophy of thenar musculature. Disappearance of pain may indicate permanent sensory loss."}
• {"criterion_text":"- History suggesting underlying causes of CTS e.g. inflammatory wrist arthritis and/or flexor tenosynovitis"}
• {"criterion_text":"- Previous significant trauma or fracture, deformity or tumor in the wrist or hand in the relevant hand"}
• {"criterion_text":"- Presence of conditions affecting a normal nerve function e.g. cervical disc herniation, polyneuropathy or previous nerve injury"}
• {"criterion_text":"- Major co-morbidities, such as severe malignancies, severe or uncontrolled infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV) and/or Side 29 av 127 severe respiratory diseases, severe renal failure, active ulcus ventriculi, leukopenia and/or thrombocytopenia"}
• {"criterion_text":"- Severe psychiatric or mental disorders"}
• {"criterion_text":"- Local infection or wound in the affected hand/wrist"}
• {"criterion_text":"- Any other medical condition that according to the treating physician and/or local guidelines makes adherence to treatment protocol impossible"}

Primary endpoints

• {"endpoint_text":"- Successful treatment outcome after one year, defined as attainment of Boston Carpal Tunnel Questionnaire Symptom Score ≤ 1.5","definition_or_measurement_approach":"Defined as attainment of Boston Carpal Tunnel Questionnaire Symptom Score ≤ 1.5 at one year"}

Secondary endpoints

• {"endpoint_text":"- Successful treatment result (as defined above) after 3, 6 and 24 months","definition_or_measurement_approach":"As defined for the primary endpoint (Boston Carpal Tunnel Questionnaire Symptom Score ≤ 1.5) assessed at 3, 6 and 24 months"}
• {"endpoint_text":"- Successful treatment result after one injection, and after two injections","definition_or_measurement_approach":"Success defined as attainment of Boston Carpal Tunnel Questionnaire Symptom Score ≤ 1.5 after one and after two injections"}
• {"endpoint_text":"- Patients in the injection arm who have undergone surgery after 3 weeks, 3, 6, 12 and 24 months","definition_or_measurement_approach":"Proportion of injection-arm patients who have undergone subsequent surgery at specified time points"}
• {"endpoint_text":"- Work performance/participation and health care utilization as outlined in section 8.8 at each, or a combination, of time points.","definition_or_measurement_approach":"Work performance/participation and healthcare utilization measured as specified in protocol section 8.8 at listed time points"}
• {"endpoint_text":"- Adverse events throughout the study","definition_or_measurement_approach":"Collection and reporting of adverse events throughout study duration per protocol safety reporting procedures"}
• {"endpoint_text":"- Patient-reported measures of symptoms and function, ultrasound and NCS measures as outlined in section 8.1 at each time point","definition_or_measurement_approach":"Patient-reported outcome measures, ultrasound and nerve conduction studies (NCS) per protocol section 8.1 at scheduled visits"}
• {"endpoint_text":"- Emitted CO2-equivalents per treatment strategy pathway.","definition_or_measurement_approach":"Environmental impact measured as emitted CO2-equivalents per treatment strategy pathway"}

Norway

Earliest CTIS Part Ii Submission Date

04-06-2024

Latest Decision Or Authorization Date

19-06-2024

Processing Time Days

15

Number Of Sites

4

Number Of Participants

258

Primary sponsor

Full Name

Diakonhjemmet Sykehus AS

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"Norway","full_name":"Oslo University Hospital HF","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}