Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)

NCT01075971 | Completed Phase 2 Results

• 1 other identifier: P04451
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, open-label, preference study of two sublingual formulations of buprenorphine HCl, in opioid-dependent patients on buprenorphine maintenance therapy. The objectives of this study are to evaluate the overall preference between two buprenorphine sublingual formulations, after a switch from the marketed tablet (Subutex®) to the new fast dissolving tablet (FDT), in opioid-dependent patients with buprenorphine 8 mg or 16 mg daily maintenance therapy.

Conditions

Opioid Dependency

Keywords

Buprenorphine tablet; Fast dissolving tablet; Opioid dependant patients

Outcome Measures

Primary Outcomes (1)

• The Overall Preference Between Two Buprenorphine Sublingual Formulations, After a Switch From the Marketed Tablet (Subutex®) to the New Fast Dissolving Tablet (FDT), in Opioid-dependent Patients With Buprenorphine 8 mg or 16 mg Daily Maintenance Therapy.

  Patient's overall satisfaction on Day 1 to Day 5 postdose. Marketed sublingual tablet (Marketed SL): Days 1 and 2; Fast dissolving tablet (FTD): Days 3, 4, and 5. Within 1 hour after complete dissolution of the tablet(s), overall satisfaction towards the study treatment was to be scored by the patient himself / herself using a 10-cm visual analogic scale (VAS) ranging from "Not at all satisfied" (score = 0) to "Totally satisfied" (score = 10).

  Daily, Day 1 to Day 5

Study Arms (1)

Buprenorphine hydrochloride

EXPERIMENTAL

Drug: Buprenorphine hydrochloride marketed sublingual tablet (Subutex); Drug: Buprenorphine hydrochloride fast dissolving tablet (FDT)

Interventions

Buprenorphine hydrochloride marketed sublingual tablet (Subutex) DRUG

8 mg or 16 mg daily, sublingual route on Days 1 and 2

Also known as: Subutex®

Buprenorphine hydrochloride

Buprenorphine hydrochloride fast dissolving tablet (FDT) DRUG

8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5

Buprenorphine hydrochloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
• Patients must be at least (≥) 18 years of age, of either sex.
• Patients treated for opioid dependence with Subutex®, with a stable dosage of 8 mg or 16 mg daily, and respecting the legal drug attachments.
• Patients must understand and be able to adhere to the dosing and visit schedules, and agree to report concomitant medications / products and adverse events to the investigator or designee.
• Women of childbearing potential (includes women who are less than one year postmenopausal and women who become sexually active) must be using or agree to use an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterile (e.g., hysterectomy or tubal ligation).
• Women of childbearing potential should be counseled in the appropriate use of birth control while in this study. Women who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.

You may not qualify if:

• Patients refusing to take the daily dose of the study medication under control in the center.
• Patients unable to complete the evaluations.
• Women who are pregnant or nursing.
• Patients with a history of hypersensitivity to buprenorphine hydrochloride or any excipient of one of its formulations.
• Patients with a current evidence of alcohol abuse.
• Patients with severe respiratory dysfunction, severe hepatic dysfunction, acute alcohol intoxication or delirium tremens.
• Initiation or increase in the dose, within the past 7 days or scheduled during the study, of a treatment with:
• benzodiazepines,
• other depressants of the central nervous system: other morphine derivatives (analgesics, antitussives), certain antidepressive agents, sedative H1 antihistamines, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines, neuroleptics, clonidine and clonidine-like agents,
• monoamine oxydase \[MAO\] inhibitors.
• Patients who have any current evidence of clinically significant hematopoietic, metabolic, cardiovascular, immunologic, neurologic, hematological, gastrointestinal, hepatic, renal, psychiatric, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the investigator, may interfere with the study evaluations or affect patient safety.
• Patients who have used any investigational product within 30 days prior to enrollment.
• Patients participating in another trial at the same time.
• Patients intending to donate blood during the study or within 3 months after study completion.
• Patients without Social Security number, or whose maximum annual compensation (3,800 €) has been exceeded.

Sponsors & Collaborators

• Indivior Inc.: lead
• Reckitt Benckiser LLC: collaborator

MeSH Terms

Interventions

Buprenorphine

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Head, Clinical Trials Registry & Results Disclosure Group
• Organization: Schering-Plough

ClinicalTrialsDisclosure@spcorp.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: September 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: April 11, 2023
• Results First Posted: April 13, 2010

Record last verified: 2023-03