| CTRI Number |
CTRI/2024/11/076104 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the pain relief in percentage between two Medications in patients with Lung Cancer : A Study on Tramadol/Acetaminophen vs. Codeine/Acetaminophen |
|
Scientific Title of Study
|
Comparison of fixed dose combination of Tramadol/Acetaminophen VS Codeine/Acetaminophen for management of mild-moderate pain in patients diagnosed with lung carcinoma - A Randomised Double Blinded Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHARUN MATHEW JOHN |
| Designation |
JUNIOR RESIDENT - PG 1 |
| Affiliation |
BASAVATARAKAM INDO AMERICAN CANCER HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Room no 120. Block 1 BASAVATRARAKAM INDO AMERICAN CANCER HOSPITAL AND RESEARCH INSTITUTE
ROAD NO 10 IAS OFFICERS QUATERS NANDI NAGAR BANJARA HILLS HYDERABAD
Hyderabad
TELANGANA
500034
India |
| Phone |
8281196074 |
| Fax |
|
| Email |
sharunmathewjohn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRANEETH SUVVARI |
| Designation |
CONSULTANT - PAIN AND PALLIATIVE |
| Affiliation |
BASAVATRARAKAM INDO AMERICAN CANCER HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Room no 120. Block 1 BASAVATRARAKAM INDO AMERICAN CANCER HOSPITAL AND RESEARCH INSTITUTE
ROAD NO 10 IAS OFFICERS QUATERS NANDI NAGAR BANJARA HILLS HYDERABAD
Hyderabad
TELANGANA
500034
India |
| Phone |
9814686999 |
| Fax |
|
| Email |
praneethsuv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRANEETH SUVVARI |
| Designation |
CONSULTANT - PAIN AND PALLIATIVE |
| Affiliation |
BASAVATRARAKAM INDO AMERICAN CANCER HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Room no 120 Block 1 BASAVATRARAKAM INDO AMERICAN CANCER HOSPITAL AND RESEARCH INSTITUTE
ROAD NO 10 IAS OFFICERS QUATERS NANDI NAGAR BANJARA HILLS HYDERABAD
Hyderabad
TELANGANA
500034
India |
| Phone |
9814686999 |
| Fax |
|
| Email |
praneethsuv@gmail.com |
|
|
Source of Monetary or Material Support
|
| BASAVATRARAKAM INDO AMERICAN CANCER HOSPITAL AND RESEARCH INSTITUTE Road No. 10, IAS Officers Quaters, Nandi Nagar, Banjara Hills, Hyderabad, Telangana 500034, India |
|
|
Primary Sponsor
|
| Name |
BASAVATRARAKAM INDO AMERICAN CANCER HOSPITAL AND RESEARCH INSTITUTE |
| Address |
BASAVATRARAKAM INDO AMERICAN CANCER HOSPITAL AND RESEARCH INSTITUTE Road No. 10, IAS Officers Quaters, Nandi Nagar, Banjara Hills, Hyderabad, Telangana 500034, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SHARUN MATHEW JOHN |
BASAVATARAKAM INDO AMERICAN CANCER HOSPITAL AND RESEARCH INSTITUTE |
Room No 120, Block1 Pain and Palliative OPD
ROAD NO 10 IAS OFFICERS QUATERS NANDI NAGAR BANJARA HILLS HYDERABAD
Hyderabad
TELANGANA |
8281196074
sharunmathewjohn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BASAVTARAKAM INDO AMERICAN CANCER HOSPITAL AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Codeine and acetaminophen fixed drug combination |
Fixed drug combination will
be given, three times a day for a period of 2 weeks. Doses will be increased according to response up to 4 times a day for 2 weeks |
| Comparator Agent |
Tramadol and acetaminophen fixed drug combination tablet |
Fixed drug combination of tramadol and acetaminophen will be given three times a day for a period of 2 weeks. Doses will be increased to 4 times a day for 2 weeks if needed. In order to match the doses of acetaminophen, 2 tablets of 500mg will be given in this group.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult who are aged more than 18 years who have lung cancer irrespective of the stage who consent for the study. Pain score should be less than 7 in NRS and the patient should have no cognitive impairment
|
|
| ExclusionCriteria |
| Details |
Patients with cancer whose age is less than 18 and those with lung cancer who do not consent for the study.
Previous opioid users will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adequate pain relief of more than or equal to 60 percentage with the initiation of fixed dose combination of drugs |
The patients will be interviewed after the first day and on the 7th day and then on the 14th day of drug initiation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SIDE EFFECT ASSESSMENT |
DAY ONE. DAY 7, DAY 14 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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="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 is a randomized , double blinded parallel group single-centre trail comparing fixed dose combination of tramadol/acetaminophen vs Codeine/ Acetaminophen for management of mild-moderate pain in patients with lung carcinoma. The primary outcome is 60 percentage or more pain relief with initiation of fixed dose combination, assessed at 1 st day , 7th day and 14th day. The secondary outcome is to assess the side effect profile at the same time periods. |