Clinical trial of Tapentadol Nasal Spray Phase-IV
- Conditions
- Health Condition 1: R52- Pain, unspecified
- Registration Number
- CTRI/2022/02/040403
- Lead Sponsor
- TORRENT PHARMACEUTICALS LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male or female subjects aged 18-65 years, both inclusive.
2. After weaning of anaesthesia post-surgery, patients having pain intensity score >= 4 on an
11-point (0 to 10) Numeric Pain Rating Scale (NPRS).
3. Patients having physical status of I-II according to American Society of
Anaesthesiologists (ASA) classification.
4. Patient willing to give written informed consent to participate in the study.
Patients with a history of hypersensitivity to tapentadol or any of the excipients.
2. Patients who have taken any medication by intranasal route within the 72 hours prior to
enrolment.
3. 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 has
potential to reduce the seizure threshold within the past 4 weeks prior to screening.
4. Patients with history of impaired pulmonary function (significant respiratory depression,
acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence
of resuscitative equipment), severe renal or hepatic impairment, suspected paralytic ileus
or head injury.
5. Patient having history of clinically significant medical illness in past 3 months, which may compromise the patientsâ?? safety or study outcome.
6. History of alcohol, other opioids, or illicit drug abuse within past 6 months and chronic use of any opioids for any disease in past 1 month.
7. Pregnant or lactating women.
8. In the opinion of the Investigator, patient is either unable to cooperate or unlikely to
adhere with any study procedures.
9. Patients who have participated in any other investigational drug trial within the past four
weeks prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Incidence of adverse eventsTimepoint: At the end of the study
- Secondary Outcome Measures
Name Time Method Efficacy <br/ ><br>1) Proportion of patients achieving 30% reduction in pain <br/ ><br>2) Proportion of patients achieving 50% reduction in painTimepoint: at the end of study