Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT03967327
Brief Summary:
This is a randomised, active-controlled, double-blind, double-dummy, parallel group study with BUP TDS 20 mg (release rate 35 µg/h), 30 mg (release rate 52.5 µg/h) and 40 mg (release rate 70 µg/h), and MOR SR 60 mg, 100 mg or 120 mg per day.
The study consists of 3 phases: a Pre-randomisation Phase, a Double-blind Phase and a Safety Follow-up Phase.
There will be 194 subjects to be randomized, with 97 randomized subjects in each arm to ensure 154 evaluable (per protocol population) subjects in the study.
Detailed Description:
AE data are obtained by the Investigators through observation of the Subject (including examinations and investigations), from any information volunteered by the Subject and through active questioning. At each visit after informed consent has been signed, Subjects will be asked about AEs that occurred since the last visit by questioning them with regard to their well-being by "non-leading" questions. This includes AEs occurring during the administration of IMP, as well as changes in concomitant diseases (e.g. ongoing medical history). The general type of questions could be similar to "Do you have any health problems?" or "Have you had any health problems since your last clinic visit?" During blinded studies, the Subject and all personnel involved with the conduct and interpretation of the study, including the Investigators, site personnel, and the Sponsor's staff, those involved in processing and regulatory reporting of SUSARs, will be blinded to the treatment codes until unblinding. The randomisation schedule will be filed securely by the Sponsor/IRS provider in a manner such that blinding is properly maintained throughout the study. Treatment codes will not be available until unblinding, after completion of the study and data base lock, except in the case of emergency.
Statistical analyses will be performed by a designated CRO. All statistical analyses will be performed using SAS and/or other statistical software as required.
Study:
NCT03967327
Study Brief:
Protocol Section:
NCT03967327