Clinical trial

Effect of Early Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury

Name

36264PR152/3/23

Description

This prospective randomized double blinded study will be conducted to evaluate the effect of early pharmacologic intervention with calcitonin on the incidence or the severity of neuropathic pain after spinal cord injury

Trial arms

Trial start

2023-05-01

Estimated PCD

2025-05-01

Trial end

2026-02-01

Status

Recruiting

Treatment

Calcitonin

patients in this group will receive 100 IU (1 ml) of calcitonin subcutaneously per day for 2 weeks starting within 48 hours after injury.

Arms:

Calcitonin group

Placebo

patients in this group will receive 1 ml of saline placebo solution subcutaneously per day for 2 weeks starting within 48 hours after injury.

Arms:

Placebo group

Size

Primary endpoint

Intensity of neuropathic pain

6 months after spinal cord injury

Eligibility criteria

Inclusion Criteria: * Patients aged ≥18 years, with spinal cord injury at any level and any degree of completeness in the early stage of trauma. Exclusion Criteria: * Intake of anticonvulsants medications. * Evidence of neuropathic pain. * Evidence of previous allergic reaction to calcitonin. * Patients with renal, hepatic and cardiac dysfunction.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-05-08

1 organization

1 product

1 drug

3 indications

Organization

Product

Indication

Indication

Indication

Drug