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Clinical Trials/CTRI/2024/05/067264
CTRI/2024/05/067264
Not yet recruiting
未知

Retrospective observational study to assess efficacy of Tapentadol nasal spray in moderate to severe back ache patients - NI

Dr Shobhan Mandal0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
Sponsor
Dr Shobhan Mandal
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational

Investigators

Sponsor
Dr Shobhan Mandal

Eligibility Criteria

Inclusion Criteria

  • •1 Patients must have a medical history and physical and neurological examinations that support a clinical diagnosis of acute/ chronic low back pain that is felt down to the lower leg below the knee.
  • •2 Patients must be able to appropriately verbalize pain characteristics and to complete all protocol required measurements/assessments without assistance. Patients must be medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening

Exclusion Criteria

  • •1 History of hypersensitivity to Tapentadol.
  • •2 Active or suspected gastrointestinal ulcers, bleeding, or motility disorders within the past 6 months prior to screening.
  • •3 Recent intranasal medication within the 72 hours preceding randomization.
  • •4 Analgesic administration post\-operatively before enrolment.
  • •5 Concurrent use of tricyclic antidepressants, selective serotonin reuptake inhibitors, selective noradrenaline reuptake inhibitors, anticonvulsants, neuroleptics, triptans, steroids, monoamine oxidase inhibitors, or drugs with potential to lower seizure threshold in the 4 weeks prior to enrolment.
  • •6 History of seizures.
  • •7 Mild to moderate traumatic brain injury, stroke, or brain neoplasm within the past year or severe traumatic brain injury within the last 15 days.
  • •8 Clinically significant ECG abnormalities or QTC greater than or equal to 450 msec for males and greater than or equal to 470 msec for females at screening.
  • •9 Pregnancy or lactation. Bronchial Asthma and COPD

Outcomes

Primary Outcomes

Not specified

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