A Phase 2 Multi-Center Open-label Study to Assess the Safety and Tolerability of a Buprenorphine/Naloxone Film Strip Administered by the Sublingual and Buccal Routes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 3
- 主要终点
- Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.
研究概览
简要总结
This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.
详细描述
Buprenorphine and naloxone soluble film was developed as an alternative dosage form to Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both sublingual and buccal administration. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Suboxone (buprenorphine and naloxone) product:
- mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format.
- improvement in subject convenience and compliance by ensuring rapid disintegration.
- protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting.
- provision of a unit dose product format for hospital and institutional use.
- decreased product damage during shipping as compared to Suboxone tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must:
- •Be 18-to-65 years of age, inclusive.
- •Have a diagnosis of opioid dependence by medical history according to DSM-IV-TR criteria.
- •Be on stable dose of 4 to 32 mg (expressed as the buprenorphine component)daily of Suboxone for at least 30 days.
- •If female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control which may include:
排除标准
- •Subjects must not:
- •Have participated in an experimental drug or device study within the last 30 days.
- •If female, be breast feeding or lactating.
- •Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study.
- •Have a clinically significant abnormal finding (in the opinion of the Investigator) on oral cavity exam (e.g., active mouth ulcers).
- •Have any piercing of the tongue or mouth within 30 days prior to the first dose of study medication.
研究组 & 干预措施
Sublingual administration
Buprenorphine/naloxone film strip administered sublingually
干预措施: Buprenorphine/naloxone Film Strip (Drug)
Buccal administration
Buprenorphine/naloxone film strip administered buccally
干预措施: Buprenorphine/naloxone Film Strip (Drug)
结局指标
主要结局
Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.
时间窗: 12 weeks
Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows: Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs
Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity
时间窗: 12 weeks
Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.
次要结局
未报告次要终点