Clinical Trial Results:
A randomised, controlled, open-label, single-centre, parallel group, pilot study to investigate the onset of action of a lozenge compared with a caplet in patients with sore throat.
Summary
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EudraCT number |
2006-006769-17 |
Trial protocol |
GB |
Global end of trial date |
07 Feb 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Mar 2018
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First version publication date |
09 Mar 2018
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
TH0612
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Reckitt Benckiser Healthcare International Ltd
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Sponsor organisation address |
103 - 105 Bath Road, Slough, Berkshire, United Kingdom, SL1 3UH
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Public contact |
Clinical Research, Clinical Research Director, clinicalrequests@rb.com
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Scientific contact |
Clinical Research, Clinical Research Director, clinicalrequests@rb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Oct 2008
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Feb 2008
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Feb 2008
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Train a UK centre in the 2-stopwatch technique to evaluate the appropriateness of the 2-stopwatch method in the sore throat indication.
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Protection of trial subjects |
This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice(GCP) and the ethical principles contained within the Declaration of Helsinki, as referenced in EU Directive 2001/20/EC.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 May 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 23
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Worldwide total number of subjects |
23
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EEA total number of subjects |
23
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
1
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Adults (18-64 years) |
22
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This was a single-centre study, recruited in United Kingdom. 132 subject were screened, out of 109 were screen failures. | |||||||||||||||
Pre-assignment
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Screening details |
Twenty-three subjects entered the study. Eleven subjects were randomised to receive a single Strefen Honey & Lemon lozenge(flurbiprofen) and 12 randomised to receive a single dose of two Ibuprofen caplets. | |||||||||||||||
Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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1 x Strefen Honey & Lemon lozenge(flurbiprofen) | |||||||||||||||
Arm description |
Test : Strefen Honey & Lemon 8.75mg flurbiprofen one lozenge by mouth | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Strefen Honey & Lemon lozenge
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Lozenge
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Routes of administration |
Oral use
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Dosage and administration details |
Strefen Honey & Lemon 8.75mg flurbiprofen one lozenge by mouth
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Arm title
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2 x Ibuprofen Caplets | |||||||||||||||
Arm description |
Reference : Ibuprofen Caplets, 200mg ibuprofen two caplets by mouth | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Ibuprofen Caplets
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Ibuprofen Caplets, 200mg ibuprofen two caplets by mouth
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Baseline characteristics reporting groups
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Reporting group title |
1 x Strefen Honey & Lemon lozenge(flurbiprofen)
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Reporting group description |
Test : Strefen Honey & Lemon 8.75mg flurbiprofen one lozenge by mouth | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
2 x Ibuprofen Caplets
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Reporting group description |
Reference : Ibuprofen Caplets, 200mg ibuprofen two caplets by mouth | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
1 x Strefen Honey & Lemon lozenge(flurbiprofen)
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Reporting group description |
Test : Strefen Honey & Lemon 8.75mg flurbiprofen one lozenge by mouth | ||
Reporting group title |
2 x Ibuprofen Caplets
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Reporting group description |
Reference : Ibuprofen Caplets, 200mg ibuprofen two caplets by mouth |
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End point title |
Median Time to first confirmed perceptible sore throat pain relief | |||||||||||||||
End point description |
KM median - Kaplan-Meier median
Intention-to-treat (ITT) population consisted of all patients who were randomized to the study, who completed the baseline efficacy assessments and who had at least one post-baseline assessment.
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End point type |
Primary
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End point timeframe |
At Baseline (pre-dose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 minutes post-dose
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Statistical analysis title |
Sore throat relief: lozenge Vs Caplets | |||||||||||||||
Comparison groups |
1 x Strefen Honey & Lemon lozenge(flurbiprofen) v 2 x Ibuprofen Caplets
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Number of subjects included in analysis |
23
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.1205 | |||||||||||||||
Method |
Regression, Cox | |||||||||||||||
Confidence interval |
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End point title |
Median time to meaningful sore throat pain relief | ||||||||||||
End point description |
KM median - Kaplan-Meier median
ITT population.
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End point type |
Secondary
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End point timeframe |
At Baseline (pre-dose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 minutes post-dose
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No statistical analyses for this end point |
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End point title |
Median Time to first unconfirmed perceptible sore throat pain relief | ||||||||||||
End point description |
KM median - Kaplan-Meier median
ITT population.
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End point type |
Secondary
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End point timeframe |
At Baseline (pre-dose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 minutes post-dose
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No statistical analyses for this end point |
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End point title |
Mean change from baseline in throat soreness sore throat relief | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Changes in throat soreness measured using 11-point ordinal scale where 0 = “Not Sore” and 10 = “Very Sore”.
ITT population.
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End point type |
Secondary
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End point timeframe |
At Baseline (pre-dose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 minutes post-dose
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No statistical analyses for this end point |
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End point title |
Mean change from baseline in difficulty in swallowing | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Difficulty in swallowing measured using 100 mm VAS with “Not Difficult” on the left hand side of the 100mm line and “Very Difficult” on the right hand side.
ITT population.
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End point type |
Secondary
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End point timeframe |
At Baseline (pre-dose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 minutes post-dose
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No statistical analyses for this end point |
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End point title |
Mean change for sore throat relief at various time points | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Sore throat relief measured using 7 point rating scale where assessed to 7 = complete relief, 6 = almost complete relief, 5 = considerable relief, 4 = moderate relief, 3 = mild relief, 2 = slight relief and 1 = no relief.
ITT population
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End point type |
Secondary
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End point timeframe |
At 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 minutes post-dose
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No statistical analyses for this end point |
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End point title |
Mean scores for overall treatment rating | ||||||||||||
End point description |
Overall Treatment Rating assessed using an 11-point ordinal scale where 0 = “Poor” and 10 = “Excellent”.
ITT population
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End point type |
Secondary
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End point timeframe |
At 120 mins
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No statistical analyses for this end point |
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End point title |
Number of patients issued with Strepsils at Discharge | |||||||||
End point description |
ITT population
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End point type |
Secondary
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End point timeframe |
At 120 minutes post-dose
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Adverse Events (AEs) | ||||||||||||||||||||||||
End point description |
Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied:
Mild = AE does not limit usual activities; the subject may experience slight discomfort.
Moderate = AE results in some limitation of usual activities; the subject may experience significant discomfort.
Severe = AE results in an inability to carry out usual activities; the subject may experience intolerable discomfort or pain.
Relationship to Investigational Medicinal Products (IMP):
Possible = Reasonable suspicion that the AE was caused by the IMP.
Unlikely = Slight, but remote, chance that the AE was caused by the IMP, but the balance of judgment is that it was most likely not due to the IMP.
Unrelated = No possibility that the AE was caused by the IMP.
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End point type |
Secondary
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End point timeframe |
Up to 12 hours (Visit 1)
Safety population consist of all patients taking at least one dose of study medication.
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Up to 12 hours (Visit 1)
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Adverse event reporting additional description |
Safety population.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.1
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Reporting groups
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Reporting group title |
1 x Strefen Honey & Lemon lozenge(flurbiprofen)
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Reporting group description |
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Reporting group title |
2 x Ibuprofen Caplets
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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21 Jun 2007 |
The substantial amendments to a clinical trial, dated 20 June 2007, 21 June 2007, 10 October 2007 and 18 October 2007, initiated by the Investigator, documented the study suspension, study recommencement, and a minor change to the Patient Information Sheet, respectively. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
The study was stopped prematurely, before the planned number of subjects was recruited. The study was ended after 23 subjects had been enrolled and 21 of the 23 enrolled subjects completed the study. |