To compare the efficacy and safety of Oral Trans-Mucosal Fentanyl Citrate vs. oral morphine in patients with break through cancer pain.

Phase 4

Completed

• Conditions: Health Condition 1: null- Break Through Cancer Pain

• Registration Number: CTRI/2010/091/001179
• Lead Sponsor: Troikaa Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1. The patient is at least 18 years old.

2. Patients experience persistent moderate pain associated with cancer or cancer treatment (NRS 5 or less).

3. For at least 7 days before enrolment, the patient must be stabilized on atleast 60 mg/day of oral morphine or its equivalent around-the-clock (ATC) dose to treat persistent pain.

4. The patient regularly experiences between 1 and 4 episodes of cancer-related BTP (NRS 5 or more) per day while taking ATC opioid therapy.

5. The patient is capable of self-administering OTFC by sucking lozenge, producing sufficient saliva to dissolve the lozenge over 15 minutes, and swallowing the saliva.

6. The patient willingly provides informed consent to participate in this study

Exclusion Criteria

1. The patient experiences uncontrolled or rapidly escalating pain, as determined by the investigator, such that ATC administration of pain medication might be expected to change during the course of the study.
2. The patient has known or suspected hypersensitivities and/or allergies to fentanyl or morphine.
3. The patient has a recent history or current evidence or abuse of alcohol or any other drug substance, elicit or collection.
4. The patient has neurological or psychiatric disease sufficient, in the investigator's opinion, to compromise data collection.
5. The patient received any other therapy (eg, radiotherapy) within a 1 week period prior to entering the study that, in the investigator's opinion, could alter pain or response to pain medication.
6. The patient has moderate to severe oral mucositis.
7. The patient is pregnant, nursing, or is of child-bearing potential or not taking adequate contraceptive measures.
8. The patient has participated in a trial of an unapproved drug in the previous 8 weeks.
9. The patient has been diagnosed with either severe respiratory depression or severe obstructive lung conditions.
10. The patient has history of convulsive disorder, head injury or comatose.
11. The patient has used monoamine-oxidase inhibitors (MAOI's) within the 2-week period prior to entering the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Improvement in pain intensity as determined by verbal numerical rating scale (NRS, 0-10 scale). <br/ ><br>2.Reduction in pain intensity by 33% at 15 minutesTimepoint: 1. 0 (Basaline) 5 15 30 and 60 minutes after administration of Investigational Product on Day 1 2 and 3;1.Improvement in pain intensity as determined by verbal numerical rating scale (NRS, 0-10 scale). <br/ ><br>2.Reduction in pain intensity by 33% at 15 minutesTimepoint: 1. 0 (Basaline) 5 15 30 and 60 minutes after administration of Investigational Product on Day 1 2 and 3

Secondary Outcome Measures

Name	Time	Method
Patients' global assessmentTimepoint: At the end of study;Physicians global assessmentTimepoint: At the end of study;Requirement of recue analgesiaTimepoint: On day 1 2 and 3;Severity of opioid related side effects on 0-3 scaleTimepoint: On Day 1, 2 & 3.