Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03282045 |
| Other study ID # |
BOS_CS_01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
October 2016 |
| Est. completion date |
May 24, 2018 |
Study information
| Verified date |
March 2021 |
| Source |
Bosnalijek D.D |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary objective of this multicenter, single-blind, randomized, placebo-controlled,
prospective, comparative study with parallel design and 4-arms is to evaluate superiority of
Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray®
against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the
pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
Description:
This study will be conducted in approximately 3 centers in Bosnia Herzegovina and in 4
centers in Turkey.
Primary objective:
The primary objective of this study is to evaluate superiority of Lysobact Complete Spray®
against placebo and non inferiority of Lysobact Complete Spray® against active comparators
(Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by
the patient using Sore Throat Pain Intensity Scale (STPIS).
Secondary objective(s):
- Safety evaluation of Lysobact Complete Spray®, Tantum Verde® Spray, Pharyngal®
Oromucosal Spray, based on the frequency and nature of adverse events occurring during
treatment period.
- Extent of change in difficulty in swallowing, evaluated on the basis of Difficulty in
Swallowing Scale (DSS), on Day 2, Day 4 and Day 6, as compared with baseline.
- Extent of change in swollen throat evaluation based on Swollen Throat Scale (STS) on Day
2, Day 4 and Day 6, as compared with baseline.
- Change in frequency of study treatment applications on Day 2, Day 4 and Day 6, as
compared with baseline.
Test product: Lysobact Complete Spray® Active comparator product: Tantum Verde® Spray Active
comparator product: Pharyngal® Oromucosal Spray Placebo product: Placebo
Primary endpoint:
• Primary endpoint is the change from baseline to Day 6 in mean VAS score for STPIS.
Secondary endpoint(s):
Secondary endpoints are as follows:
- change from baseline to Day 6 in mean VAS score for DSS
- change from baseline to Day 6 in mean VAS score for SwoTS
- change from baseline to each visit (Day 2, Day 4, Day 6) for STPIS , DSS and SwoTS
- percent improvement from baseline to each visit (Day 2, Day 4, Day 6) for STPIS , DSS
and SwoTS
- Incidence of adverse events and relationship to the study treatments
- Incidence of serious adverse events and relationship to the study treatments
Statistical methods:
All patients who have received at least one dose of any study medication will be included in
the safety evaluation (safety population). Patients who have completed all visits according
to the protocol will be included in the efficacy population. The superiority and inferiority
of Lysobact Complete Spray® will be tested in hierarchical order by the comparison of the
mean change of VAS scores [Sore Throat Pain Intensity Scale (STPIS)] from baseline to Day 2,
4 and 6.
Planned treatment duration is 5 days. Safety will be followed-up until Day 6. End of study is
defined as the end of the follow up period for the last patient.
