Phase-III clinical trial of Tapentadol Nasal Spray in comparision with Tramadol

Phase 3

Not yet recruiting

Conditions: Health Condition 1: R52- Pain, unspecified

Registration Number: CTRI/2022/01/039128

Lead Sponsor: Torrent Pharmaceuticals Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Lumbago :

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.

Trauma :

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

Exclusion Criteria

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

screening.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Pain intensity difference (PID) at 60 minutes from baseline after administering the <br/ ><br>first dose of tapentadol nasal spray or tramadol. <br/ ><br>2. Patient global assessment at 120 hours/end of treatmentTimepoint: 1. Pain intensity difference (PID) at 60 minutes from baseline after administering the <br/ ><br>first dose of tapentadol nasal spray or tramadol. <br/ ><br>2. Patient global assessment at 120 hours/end of treatment

Secondary Outcome Measures

Name	Time	Method
1) Sum of Pain Intensity Difference (SPID) every 24 hours till the end of the treatment. <br/ ><br>2) Proportion of patients achieving 30% and 50% reduction in pain intensity from baseline. <br/ ><br>3) Time to onset of meaningful pain relief after first dose (Day 0) administration. <br/ ><br>4)Time to the first intake of rescue medication for pain. <br/ ><br>5) Patient global assessment at 24 hours. <br/ ><br>comparison to the tramadol in patients with acute moderate to severe painTimepoint: at 24 hours till end of the treatment