| CTRI Number |
CTRI/2024/07/070787 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of two drugs sublingual Buprenorphine and oral Tramadol for pain management in patients with cancer. |
|
Scientific Title of Study
|
An open-labelled multicentric noninferiority randomized
controlled trial to compare sublingual Buprenorphine versus oral Tramadol for cancer pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunu Lazar Cyriac |
| Designation |
Associate Professor |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department Of Medical Oncology
Room No. 618
6th Floor, SH Block,
Amala Institute of Medical Sciences
Amala Nagar P O
Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9567602426 |
| Fax |
|
| Email |
drsunucyriac@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh L John |
| Designation |
Assistant Professor |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Pain and Palliative Medicine
Amala Institute of Medical Sciences
Amala Nagar P O
Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9207803695 |
| Fax |
|
| Email |
rakeshljohn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh L John |
| Designation |
Assistant Professor |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Pain and Palliative Medicine
Amala Institute of Medical Sciences
Amala Nagar
Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9207803695 |
| Fax |
|
| Email |
rakeshljohn@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR [Indian Council of Medical Research]
V Ramalingaswami Bhawan
P O Box 4911
Ansari Nagar
New Delhi 110029
India |
|
|
Primary Sponsor
|
| Name |
ICMR Indian Council of Medical Research |
| Address |
Indian Council of Medical Research
V Ramalingaswami Bhawan
P O Box 4911
Ansari Nagar
New Delhi 110029
India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajit Kumar |
All India Institute of Medical Sciences |
Department of Anesthesiology
Virbhadra marg
Pashulok
Rishikesh 249203
Dehradun
UTTARANCHAL |
9910789377
ajitdrajit@gmail.com |
| Dr Sunu Lazar Cyriac |
Amala Institute of Medical Sciences |
Amala Institute of Medical Sciences
Amala Nagar P O
Thrissur 680555
Thrissur
KERALA |
9567602426
drsunucyriac@gmail.com |
| Dr Sanket Hirenbhai Mehta |
Bhaikaka University |
Department OF Anesthesiology
Anand 388325
Anand
GUJARAT |
9427851645
drsanketm@rediffmail.com |
| Dr Pamela Alice Jeyaraj |
Christian Medical College & Hospital |
Department of Radiation Oncology
ludhiana-141008
Ludhiana
PUNJAB |
8558821500
pamela.jeyaraj@cmcludhiana.in |
| Dr Soumya Surath Panda |
Institute of Medical Sciences and SUM Hospital |
Department of Medical Oncology Room No. 52
K8 kalinga Nagar
Ghatika Bhubaneswar
751003
Khordha
ORISSA |
8895370579
soumyasurathpanda@soa.ac.in |
| Dr Gunaseelan Karunanithi |
JIPMER puducherry |
Department of Radiation Oncology
Puducherry 605006
Pondicherry
PONDICHERRY |
9362966444
gunapgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| IEC Amala Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee(IEC) |
Approved |
| Institutional Ethics Committee- Interventional Studies |
Approved |
| Institutional Ethics Committee-2 |
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 |
Buprenorphine Sublingual |
Buprenorphine Sublingual 0.2 mcg Three times daily for 84 days |
| Comparator Agent |
Tramadol Oral |
Tramadol Oral 50 mg three times daily for 84 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Opioid-naive [ not taken any opioid analgesic before the start of the study],
Diagnosed to have solid tumors, Suffering from moderate cancer pain [VAS pain of 4-7], who are assessed by the physician and have a life expectancy of more than 3 months attending the palliative and oncology units of trial centers
|
|
| ExclusionCriteria |
| Details |
Patients who cannot swallow pills. Patients who are unreliable for follow-up and unable to self-record their pain scores. Patients who give refusal of consent. Patients who have a Life expectancy of lower than 3 months based on evaluation by the physician and performance score.
All patients who have Contra-indication to adjuvants will be excluded from the study.
Patients who have severe pain or are terminally ill, psychiatric patients, and patients having brain metastasis. Patients who require adjuvant analgesics other than gabapentin and paracetamol will be excluded from the study. Patients with severe hepatic or renal dysfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic efficacy of sublingual Buprenorphine against oral Tramadol by comparing the NRS pain score between two arms at 14 days after the intervention. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the NRS Pain score between two arms of the study at 28days, 56 days, & 84 days after the intervention. To compare the adverse events between the two arms of the study using numerical opioid side effect scores & Current Opioid Misuse Measure at 14 days, 28 days,56 days & 84 days after the intervention. |
28 days
56 days
84 days |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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 3 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 an open-labeled, multicentric randomized trial comparing the analgesic effect and side effect profile of two opioid analgesics sublingual buprenorphine and oral tramadol for cancer pain. It will be conducted in six centers across India. The primary outcome is pain relief [based on reduction in VAS score], and comparison of the side effect profile [based on numerical opioid side effect scale]. Secondary outcomes include cost comparison between the two arms of the study. This is a non-inferiority study design. If found equally efficacious to tramadol, then this should bring down the treatment cost by 66-70% with lesser abuse potential and toxicities. This could provide evidence for modifications in the guidelines as well.
|