A Phase II, randomized, multi-centric, open-label, two arm study to determine the safety profile and establish the efficacy of XprenorÂ® (buprenorphine oral lyophilisate) in comparison with SubutexÂ® (buprenorphine hydrochloride) in opioid dependent patients

Martindale Pharma0 sites54 target enrollmentTBD

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Investigators

Sponsor

Martindale Pharma

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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 patientâ??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.

Outcomes

Primary Outcomes

Not specified

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