| CTRI Number |
CTRI/2013/06/003782 [Registered on: 26/06/2013] Trial Registered Prospectively |
| Last Modified On: |
03/01/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to compare safety and efficacy of two brands of buprenorphine (XPRENOR and SUBUTEX) in patients who are opioid dependent. |
|
Scientific Title of Study
|
A Phase II, randomized, multi-centric, open-label, two arm study to determine the safety profile and establish the efficacy of Xprenor® (buprenorphine oral lyophilisate) in comparison with Subutex® (buprenorphine hydrochloride) in opioid dependent patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MD2012/01XP-India, Version 03 dated 06 Feb 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gungurti Prasad Rao |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Asha Hospital, Hyderabad |
| Address |
Asha Hospital
298,Road No 14
Banjara hills
Hyderabad 500 034
Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
09985900005 |
| Fax |
|
| Email |
prasad40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Eswaraiah |
| Designation |
Head, Clinical Development, CDMB & Regulatory Affairs |
| Affiliation |
Clinigene International Ltd. Bangalore |
| Address |
Clinigene International Ltd
Tower I, Semicon Park,
Electronics City, Phase II, Hosur Road,
Bangalore 560 100, India
Bangalore
KARNATAKA
560100
India |
| Phone |
08028082728 |
| Fax |
08028082737 |
| Email |
anand.eswaraiah@clinigeneintl.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Eswaraiah |
| Designation |
Head, Clinical Development, CDMB & Regulatory Affairs |
| Affiliation |
|
| Address |
Clinigene International Ltd
Tower I, Semicon Park,
Electronics City, Phase II, Hosur Road,
Bangalore 560 100, India
KARNATAKA
560100
India |
| Phone |
08028082728 |
| Fax |
08028082737 |
| Email |
anand.eswaraiah@clinigeneintl.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Martindale Pharma |
| Address |
Macarthys Laboratories Limited (trading as Martindale Pharma)
Bampton Road, Harold Hill, Romford
Essex RM3 8UG, United Kingdom
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Clinigene International Ltd |
Tower I, Semicon Park,
Electronics City, Phase II, Hosur Road,
Bangalore 560 100, India
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gungurti Prasad Rao |
Asha Hospital |
# 298,Road # 14
Banjara hills
Hyderabad 500 034
Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH |
09985900005
prasad40@gmail.com |
| Dr Venugopal Jhanwar |
Deva Institute of Healthcare and Research Private Limited |
B-27/70 MN ,Durgakund
Varanasi 221 004
Uttar Pradesh, India
Varanasi
UTTAR PRADESH |
09936611111
vgj.dihr@gmail.com |
| Dr Sanjay Mahendru |
Mahendru Psychiatric Centre |
117/40, Sarvodaya Nagar, Kanpur - 208005, India
Kanpur Nagar
UTTAR PRADESH |
09839032699
sanjay.mahendru@yahoo.co.in |
| Dr Pratima Murthy |
NIMHANS Hospital |
Dharmaram College Post, Dairy Circle, Hosur Road, Bangalore - 560029, Karnataka, India
Bangalore
KARNATAKA |
09480829470
pratimamurthy@gmail.com |
| Dr Mariappa Srinivasa |
Spandana Healthcare |
236/2, 29th Main
5th Block, Near Ringroad Bridge
Nandini layout
Bangalore 560096
Karnataka, India
Bangalore
KARNATAKA |
09448065742
mariappasrinivasa@yahoo.com |
| Dr Vishal Indla |
Vijayawada Institute of Mental Health & Neurosciences (VIMHANS) |
29-7-32, V.V. Rao Street,
Suryaraopet, Vijayawada - 520002, India
Andhra Pradesh, India
Krishna
ANDHRA PRADESH |
09704755669
vishalindla@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| DMHC Ethics Committee, Deva Institute of Healthcare and Research Private Limited, Varanasi |
Approved |
| Ethics Committee- Asha hospital, Asha Hospital, Hyderabad |
Approved |
| Kanpur Medical Ethics Committee, Mahendru Psychiatric Centre, Kanpur |
Approved |
| NIMHANS Ethics Committee, NIMHANS Hospital, Bangalore |
Submittted/Under Review |
| Spandana Ethics Committee, Spandana Healthcare, Bangalore |
Submittted/Under Review |
| Vijayawada Institute of Mental Health and Neuro Sciences (VIMHANS) Hospital - Ethics Committee, Vijayawada Institute of Mental Health & Neurosciences (VIMHANS), Vijaywada |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Opioid Dependent, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Subutex (buprenorphine hydrochloride) |
2 mg to 4 mg daily for 7 days
[Increase daily based on patient response to a maximum of 32mg/day]
Mode of Administration : Sublingually
|
| Intervention |
Xprenor (buprenorphine oral lyophilisate) |
2 mg to 4 mg daily (Initial Dose) for 7 days
[Increase by 2-6mg daily based on patient response to a maximum of 24 mg/day]
Mode of Administration : Orally (On Tongue)
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinical condition: Opioid dependent patients, eligible for opioid substitution therapy.
2.Gender: Male or Female.
3. Age: 18 - 60 years (both inclusive).
4. BMI: 18.0 to 30.0 Kg/m2
5. Capable of providing voluntary informed consent.
6. Female patients who are sexually active will be of non-child bearing potential (i.e., surgically sterilized or postmenopausal), abstain from sexual intercourse, or use a reliable method of contraception (e.g. hormonal contraceptive, condom with spermicide, IUD) for at least 30 days prior to dosing and during the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1.Current or previous (within previous 2 days) dependence treatment, e.g. buprenorphine or methadone.
2.Hypersensitivity to buprenorphine or any other component of the oral lyophilisate.
3.Positive urine drug test for cocaine or amphetamines at screening.
4.Severe hepatic insufficiency (defined as liver function tests, including alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase, greater than three times the upper limit of normal).
5.Concomitant use of benzodiazepines, which may potentiate respiratory depression, above recommended therapeutic doses or patients who are not stabilized on benzodiazepine therapy.
6.Concomitant use of other central nervous system depressant, such as other opioid derivatives, certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances.
7.Concomitant use of monoamine oxidase inhibitors, which may aggravate opioid effects.
8.Administration of any approved or investigational long-acting injections of antipsychotic medications.
9.Current psychiatric diagnosis of major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise the patient’s ability to complete the study.
10.Female patients with a positive pregnancy test, lactating mother, women refusing to agree to adequate contraception and pregnancy tests during the study, or women who are planning to become pregnant during the period of the trial.
11.Participation in a clinical trial of a pharmacological agent within 6 months of screening.
|
|
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Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1. To compare Oxygen desaturation as measured by pulse oximetry
2.To monitor respiration rate
3.To compare the incidence of AEs and SAEs reported in Subutex (buprenorphine hydrochloride) and Xprenor (Buprenorphine oral lyophilisate) arms |
Visit 1-day 1 to Visit 7- day 7, Visit 9- day 9 & 14- day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate and compare the reduction in opioid withdrawal symptoms
2.To evaluate and compare the reduction in scores on the Objective and Subjective Opioid Withdrawal Scale
3.To determine the satisfaction of treatment using a dose adequacy (Likert) scale |
Visit 1-day 1 to Visit 7- day 7, Visit 9- day 9 & 14- day 14 |
|
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Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/06/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is designed to determine the safety profile and establish the efficacy of Xprenor (buprenorphine oral lyophilisate) in comparison with Subutex (buprenorphine hydrochloride) in opioid dependent patients.
The study consists of an induction period of up to 7 days where patients identify a dose of Xprenor (buprenorphine oral lyophilisate) or Subutex [(buprenorphine hydrochloride), an effective and approved treatment for opioid dependence], followed by a maintenance period of 7 days on the dose identified. At the end of the maintenance period, all patients will be switched to the prevailing standard of care. |