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Clinical Trial Summary

Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.


Clinical Trial Description

Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.

Patients who are currently taking sublingual (SL) BPN (weekly or monthly prescription visits) or individuals who are actively seeking BPN treatment but who have not yet begun a treatment regimen, may be eligible for the study.

Following Screening, qualified subjects meeting inclusion criteria and not meeting exclusion criteria will be initiated on either CAM2038 q1w or q4w, based on their current treatment status (qualified subjects currently on SL BPN or seeking BPN treatment). Qualified subjects will be initiated or transitioned to CAM2038 q1w or q4w as follows:

Initiation of BPN treatment - initiate with CAM2038 q1w

Currently receiving SL BPN treatments - transfer to corresponding CAM2038 q1w or q4w dose ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02672111
Study type Interventional
Source Braeburn Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date November 2015
Completion date May 2017

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