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A Phase III clinical study, performed in several sites to evaluate the efficacy and safety of the drug Lofexidine in opiate addicts (heroin, methadone and buprenorphine)which are expected to participate in a detoxification program.

''A Phase III, multicenter, open-label study, to evaluate the efficacy and safety of different dosage regimens of 0.2 mg lofexidine hydrochloride (DIMATEX) in the treatment of withdrawal symptoms during opioid detoxification''

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-004775-36-IT
Enrollment
Unknown
Registered
2011-12-22
Start date
2012-01-30
Completion date
Unknown
Last updated
2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oppiate addicts(heroin, methadone and buprenorphine) MedDRA version: 14.1 Level: LLT Classification code 10032707 Term: Other specified drug dependence, continuous use System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: DIMATEX*60CPR RIV 0,2MG Pharmaceutical Form: Tablet INN or Proposed INN: LOFEXIDINE HYDROCHLORIDE CAS Number: 21498-08-8 Concentration unit: µg microgram(s) Concentration type: equal Conce

Sponsors

GET SRL
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a)Mail and femal between 18 and 60 years. b)Subjects addicted from heroin follwing DSM-IV criteria, whom have already been decided the inclusion in a fast detoxification program or Subjects addicted from heroin following DSM IV criteria treated with methadone maintenance treatement(=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: a)Subjects with blood pressure 3N). e) Subjects positiv to HBV and /or HCV in pharmacological treatment. f)Subjects with gastric disease that could change the absorption of study drug. g)Subjects with asthma in chronic treatment. h) Subjects with severe psychiatric disorders including psychosis, bipolar disorder, schizophrenia, depression. j)Epileptics or subjects that have been treated with anticonvulsants in the last 3 years. k)Non-compliance during the study, in accordance with the Investigator opinion.

Design outcomes

Primary

MeasureTime frame
Main Objective: a) To confirm the tollerability and safety profile with the use of Lofexidine during the entire time of treatment. b) To evaluate Lofexidine efficacy undergoing drug free detoxification.;Secondary Objective: To evaluate if Lofexidine standard dosage used in English clinical practice, can be used in italian detoxification centre (Ser.T e/o Presidi delle tossicodipendenze nelle Carceri e/o Unità Operative Ospedaliere)undergoing a drug free detoxification process from heroin, methadone, buprenorphine and buprenorphine/naloxone.;Primary end point(s): a) Frequency and type of adverse events. b) Quantification of withdrawal symptoms by SOWS scale and evaluation of the ''craving'' by VAS scale.;Timepoint(s) of evaluation of this end point: Adverse events will be observed at each visit from the first treatment administration. Withdrawal and ''craving'' will be observed for each day of treatment.—

Secondary

MeasureTime frame
Secondary end point(s): 1)Number of patients who completed treatment 2)Number of subjects relapsed to opiate use during follow-up.;Timepoint(s) of evaluation of this end point: 1)Number of patients who completed treatment will be observed at the end of treatment 2)Number of subjects relapsed to opiate use during follow-up will bw observed after the follow-up—

Countries

Italy

Contacts

Public ContactSEGRETERIA ORGANIZZATIVA

FEDERSERD

federserd@expopoint.it031748814

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026