| CTRI Number |
CTRI/2025/09/094127 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two type of drugs for pain relief in cancer patients |
|
Scientific Title of Study
|
Comparative Evaluation of the Analgesic Efficacy of Transdermal Buprenorphine versus Oral Controlled Release Morphine in Patients with Malignancy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohit kumar |
| Designation |
PG resident |
| Affiliation |
VMMC AND SJH |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari
Nagar east, New Delhi,
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9015574119 |
| Fax |
|
| Email |
mkgr00766@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dimple pande |
| Designation |
Professor |
| Affiliation |
VMMC AND SJH |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari
Nagar east, New Delhi,
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9868435534 |
| Fax |
|
| Email |
truegemini21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dimple pande |
| Designation |
Professor |
| Affiliation |
VMMC AND SJH |
| Address |
Department of anaesthesia and intensive care, VMMC and Safdarjung hospital, Ansari
Nagar east, New Delhi,
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
9868435534 |
| Fax |
|
| Email |
truegemini21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital, ansari nagar, south delhi, Delhi, India,110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Ansari Nagar east, New Delhi, Delhi, 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohit kumar |
Vardhman Mahavir medical college and Safdarjung hospital |
Department of anaesthesia and
intensive care, pain clinic 2nd floor OPD, Ansari Nagar east, New Delh,110029
South
DELHI |
9015574119
mkgr00766@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir medical college and Safdarjung hospital institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral controlled-release morphine tablets |
Group A-Oral controlled-release morphine tablets 30mg BD will be given.
Pain assessment at 24hr,3 days,7 days,14 days with NRS |
| Comparator Agent |
Transdermal buprenorphine patch |
Group B- Transdermal buprenorphine patch 10mcg/hr will be given.
Pain assessment at 24hr,3 days,7 days,14 days with NRS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 65 years with malignancy related severe pain (NRS more than or equal to 7) |
|
| ExclusionCriteria |
| Details |
1.Known hypersensitivity to Buprenorphine or Morphine.
2.Severe hepatic or renal impairment
3.Significant respiratory depression or uncontrolled comorbidities.
4.Cognitive impairment preventing self reporting of pain or adverse effects.
5.History suggestive of substance abuse and mental health illness.
6.Current use of strong opioids
7.Ongoing parenteral chemotherapy or radiotherapy
8.Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic effect (using NRS) of transdermal Buprenorphine and Oral controlled release Morphine in patients with malignancy. |
24hrs,3 days, 7 days, 14 days after administration of drug. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the patient’s satisfaction and preference using a Likert scale for transdermal Buprenorphine and oral controlled release Morphine in the management of cancer pain. |
14 days |
To evaluate the quality of life using FACT-G score with the use of transdermal Buprenorphine patch and oral controlled release Morphine in patients with malignancy.
|
14 days |
To evaluate the sleep quality using verbal rating scale with the use of transdermal Buprenorphine patch and oral controlled release Morphine in patients with malignancy
|
14 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective,comparative,randomized and intervention study comparing the analgesic efficacy of transdermal buprenorphine patch with oral controlled-release morphine tablets in patients with malignancy. The primary outcome (analgesic effect) will be calculated using NRS at 24hrs,7 days,3days,14days. |