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临床试验/CTRI/2022/01/039128
CTRI/2022/01/039128尚未招募3 期

A Multi-centric, Randomized, Double-blind, Double-dummy ClinicalTrial to Evaluate Efficacy and Safety of Tapentadol Nasal Spray in Comparison toTramadol in Patients With Acute Moderate to Severe Pain - Tape NS

Torrent Pharmaceuticals Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
尚未招募
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • •Acute pancreatitis:
  • •2. Male or female subjects of 18-65 years of age, both inclusive.
  • •3. Patient willing to give written informed consent to participate in the study
  • •Patient diagnosed with acute pancreatitis based on the revised Atlanta Classification
  • •2012 i.e., acute pancreatitis established by two of the following three criteria: (1)
  • •abdominal pain consistent with acute pancreatitis; (2) serum lipase activity (or amylase
  • •activity) at least three times greater than the upper limit of normal; and (3)
  • •characteristic findings of acute pancreatitis on imaging. If the diagnosis of acute
  • •pancreatitis is established by abdominal pain and by increases in the serum pancreatic
  • •enzyme activities, imaging is not mandatory to establish the diagnosis in the emergency
  • •room or on admission to the hospital.
  • •5. Patient complaining of abdominal pain consistent with acute pancreatitis for duration
  • •not more than 24 hours.
  • •6. Patient having NPRS>=5 on an 11-point (0 to 10) Numeric Pain Rating Scale (NPRS),
  • •even after administration of acetaminophen or NSAID.
  • •7. Patient requiring treatment with opioid analgesic in the opinion of Investigator
  • •1. Male or female subjects of 18-65 years of age, both inclusive.
  • •2. Patient willing to give written informed consent to participate in the study.
  • •3. Low back pain, localized below the costal margin and above the inferior gluteal folds.
  • •4. Patients diagnosed with episode of nonspecific acute lumbago since not more than 2
  • •days prior to inclusion in the trial and more than 6 weeks after the last episode of acute
  • •low back pain.
  • •5. Patient having NPRS>=5 on an 11-point (0 to 10) Numeric Pain Rating Scale (NPRS),
  • •even after administration of acetaminophen or NSAID.
  • •6. Patient requiring treatment with opioid analgesic in the opinion of Investigator.
  • •1. Male or female subjects of 18-65 years of age, both inclusive.
  • •2. Patient willing to give written informed consent to participate in the study.
  • •3. Patient with clinical diagnosis for a musculoskeletal trauma due to traumatic injury of
  • •musculoskeletal structure of limbs like fractures, sprain, tendon rupture.
  • •4. Patient has chief complaint of musculoskeletal pain lasting not more than 2 days prior
  • •to inclusion in the trial.
  • •5. Patient having NPRS>=5 on an 11-point (0 to 10) Numeric Pain Rating Scale (NPRS),
  • •even after administration of acetaminophen or NSAID.
  • •6. Patient requiring treatment with opioid analgesic in the opinion of Investigator

排除标准

  • •1.Patients with history of hypersensitivity to tapentadol, tramadol or any of the
  • •excipients.
  • •History of active or suspected gastrointestinal ulcers or bleeding or motility disorder
  • •within the past 6 months prior to screening.
  • •Note: Investigator based on clinical judgement may initiate treatment without waiting
  • •for confirmatory lab reports; however, if the patient is confirmed for meeting any
  • •exclusion criteria based on laboratory results, patient would be withdrawn from study
  • •and will be replaced with another eligible patient
  • •3. Patients who have taken any medication by intranasal route within the past 72 hours
  • •prior to randomization.
  • •4. Patients with chronic use of any opioids for any disease within the last 28 days prior to
  • •5. Patients currently being treated with tricyclic antidepressants, selective serotonin
  • •reuptake inhibitors, selective noradrenaline reuptake inhibitors, anticonvulsants,
  • •neuroleptics, triptans, monoamine oxidase inhibitors, steroids or other drugs that have
  • •the potential to reduce the seizure threshold within the past 4 weeks prior to screening.
  • •6. History of any seizure disorder or epilepsy. Patients with increased intracranial
  • •pressure, brain tumors, head injury, or impaired consciousness.
  • •7. Patients with clinically significant ECG abnormalities.
  • •8. Any clinically significant abnormal nasal or respiratory tract conditions i.e., atrophic
  • •rhinitis, nasal polyp, upper respiratory tract infection etc. which can interfere with the
  • •absorption of the drug.
  • •9. History of drug abuse or known active alcohol abuse within the past 6 months.
  • •10. Liver enzymes (alanine transaminase, aspartate transaminase, alkaline phosphatase) >
  • •2.5X the upper limit of normal value (ULN) or total bilirubin >1.5X of ULN or serum
  • •creatinine >1.5X of ULN, and considered clinically significant by Investigator.
  • •Patients having respiratory rate less than 12 breaths per minute or greater than 20
  • •breaths per minute at randomization.
  • •12. History of active Hepatitis B or Hepatitis C or HIV infection.
  • •13. Pregnant or lactating women or females of childbearing potential, who are neither
  • •surgically sterilized nor willing to use reliable contraceptive methods throughout the
  • •study duration or male subjects of childbearing potential not willing to use reliable
  • •contraception methods throughout the study duration.
  • •14. In the opinion of the Investigator, patient is either unable to cooperate or unlikely to
  • •adhere with any study procedures.
  • •15. Patients who have participated in any other investigational drug trial within the past
  • •four weeks prior to screening.
  • •16. Evidence of obstructive pancreatitis on available cross-sectional imaging.
  • •17. Patients admitted to the Intensive Care Unit (ICU).
  • •18. Patient requiring urgent surgery within 6 days of randomization.
  • •19. Patient with evidence of chronic pancreatitis (recurrent, obstructive and chronic;
  • •autoimmune and chronic; marked pancreatic insufficiency such as steatorrhea).
  • •20. Suspected organ failure or progressing towards organ failure in the opinion of the
  • •Investigator.
  • •21.History of chronic low back pain.
  • •22.Evidence of clinically unstable

研究者

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