Trial Outcomes & Findings for Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED) (NCT NCT00550550)
NCT ID: NCT00550550
Last Updated: 2017-03-03
Results Overview
The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0 (no symptoms and no rescue medication use) to 54 (most severe symptoms and maximum use of rescue medication), with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0 (best) to 18 (worst), with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0 (no rescue medication use) to 36 (maximum use of rescue medication), with a lower score indicating less use of rescue medication.
COMPLETED
PHASE3
345 participants
From the Start of the GPS to the End of the GPS
2017-03-03
Participant Flow
A total of 345 subjects were randomized at a total of 68 sites (58 sites from United States; 10 sites from Canada) to treatment assignment, and 344 subjects received at least one dose of study medication.
Participant milestones
| Measure |
SCH 697243
SCH 697243 (Phleum pratense extract) administered sublingually once daily.
|
Placebo
Matching placebo tablet administered sublingually once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
176
|
169
|
|
Overall Study
Number Treated
|
175
|
169
|
|
Overall Study
COMPLETED
|
142
|
140
|
|
Overall Study
NOT COMPLETED
|
34
|
29
|
Reasons for withdrawal
| Measure |
SCH 697243
SCH 697243 (Phleum pratense extract) administered sublingually once daily.
|
Placebo
Matching placebo tablet administered sublingually once daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
5
|
|
Overall Study
Treatment Failure
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
8
|
|
Overall Study
Protocol Violation
|
5
|
14
|
|
Overall Study
Did Not Meet Protocol Eligibility
|
1
|
1
|
|
Overall Study
Randomized But Not Treated
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED)
Baseline characteristics by cohort
| Measure |
SCH 697243
n=175 Participants
SCH 697243 (Phleum pratense extract) administered sublingually once daily.
|
Placebo
n=169 Participants
Matching placebo tablet administered sublingually once daily.
|
Total
n=344 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.1 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
12.6 years
STANDARD_DEVIATION 3.0 • n=7 Participants
|
12.3 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
|
Gender
Female
|
57 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Gender
Male
|
118 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the Start of the GPS to the End of the GPSPopulation: The Full Analysis Set (FAS) population was comprised of all participants randomized with at least one post-treatment diary data entry.
The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0 (no symptoms and no rescue medication use) to 54 (most severe symptoms and maximum use of rescue medication), with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0 (best) to 18 (worst), with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0 (no rescue medication use) to 36 (maximum use of rescue medication), with a lower score indicating less use of rescue medication.
Outcome measures
| Measure |
SCH 697243
n=149 Participants
Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
|
Placebo
n=158 Participants
Rapidly dissolving matching placebo tablet administered sublingually once daily.
|
|---|---|---|
|
Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)
|
4.62 Units on a Scale
Standard Error 0.52
|
6.25 Units on a Scale
Standard Error 0.51
|
SECONDARY outcome
Timeframe: Start of the GPS to the End of the GPSPopulation: The FAS population was comprised of all participants with at least one post-treatment diary data entry.
The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 (best) to 18 (worst).
Outcome measures
| Measure |
SCH 697243
n=149 Participants
Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
|
Placebo
n=158 Participants
Rapidly dissolving matching placebo tablet administered sublingually once daily.
|
|---|---|---|
|
Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS
|
3.71 Units on a Scale
Standard Error 0.40
|
4.91 Units on a Scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Start of the GPS to the End of the GPSPopulation: The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry.
The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score \>= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0 (no use of rescue medication) to 36 (maximum use of rescue medication). A lower medication score indicated less impact on symptoms and was suggestive of less use of rescue medication.
Outcome measures
| Measure |
SCH 697243
n=149 Participants
Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
|
Placebo
n=158 Participants
Rapidly dissolving matching placebo tablet administered sublingually once daily.
|
|---|---|---|
|
Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS
|
0.91 Units on a Scale
Standard Error 0.25
|
1.33 Units on a Scale
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Start of the GPS to the End of the GPSPopulation: The FAS population was comprised of all participants randomized with at least one post-treatment diary data entry for the rhinoconjunctivitis quality-of-life measure.
The RQLQ has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0 (best) to 6 (worst), with a higher score indicating more significant impairment.
Outcome measures
| Measure |
SCH 697243
n=109 Participants
Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
|
Placebo
n=111 Participants
Rapidly dissolving matching placebo tablet administered sublingually once daily.
|
|---|---|---|
|
Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS
|
1.45 Units on a Scale
Standard Error 0.11
|
1.77 Units on a Scale
Standard Error 0.12
|
Adverse Events
SCH 697243
Placebo
Serious adverse events
| Measure |
SCH 697243
n=176 participants at risk
Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
|
Placebo
n=169 participants at risk
Rapidly dissolving matching placebo tablet administered sublingually once daily.
|
|---|---|---|
|
Blood and lymphatic system disorders
Idiopathic thromnocytopenic purpura
|
0.00%
0/176
|
0.59%
1/169 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/176
|
0.59%
1/169 • Number of events 1
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/176
|
0.59%
1/169 • Number of events 1
|
|
Injury, poisoning and procedural complications
Anaesthetic complications
|
0.00%
0/176
|
0.59%
1/169 • Number of events 1
|
Other adverse events
| Measure |
SCH 697243
n=176 participants at risk
Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
|
Placebo
n=169 participants at risk
Rapidly dissolving matching placebo tablet administered sublingually once daily.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pruritus
|
11.9%
21/176 • Number of events 35
|
0.59%
1/169 • Number of events 1
|
|
Eye disorders
Eye pruritis
|
9.1%
16/176 • Number of events 17
|
2.4%
4/169 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
5/176 • Number of events 6
|
5.9%
10/169 • Number of events 19
|
|
Gastrointestinal disorders
Lip swelling
|
7.4%
13/176 • Number of events 19
|
0.00%
0/169
|
|
Gastrointestinal disorders
Oedema mouth
|
10.8%
19/176 • Number of events 29
|
0.59%
1/169 • Number of events 1
|
|
Gastrointestinal disorders
Oral pruritis
|
38.6%
68/176 • Number of events 134
|
3.6%
6/169 • Number of events 11
|
|
Gastrointestinal disorders
Stomatitis
|
14.8%
26/176 • Number of events 35
|
1.2%
2/169 • Number of events 2
|
|
General disorders
Pyrexia
|
6.2%
11/176 • Number of events 12
|
7.1%
12/169 • Number of events 13
|
|
Infections and infestations
Gastroenteritis viral
|
5.1%
9/176 • Number of events 10
|
3.6%
6/169 • Number of events 6
|
|
Infections and infestations
Influenza
|
3.4%
6/176 • Number of events 6
|
5.9%
10/169 • Number of events 11
|
|
Infections and infestations
Nasopharyngitis
|
18.8%
33/176 • Number of events 42
|
23.7%
40/169 • Number of events 58
|
|
Infections and infestations
Sinusitis
|
3.4%
6/176 • Number of events 7
|
5.3%
9/169 • Number of events 9
|
|
Infections and infestations
Upper respiratory tract infection
|
15.9%
28/176 • Number of events 42
|
15.4%
26/169 • Number of events 32
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.0%
14/176 • Number of events 18
|
8.3%
14/169 • Number of events 18
|
|
Nervous system disorders
Headache
|
13.1%
23/176 • Number of events 40
|
13.6%
23/169 • Number of events 38
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
16/176 • Number of events 20
|
11.2%
19/169 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.4%
6/176 • Number of events 11
|
5.3%
9/169 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.4%
13/176 • Number of events 21
|
5.3%
9/169 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.3%
27/176 • Number of events 34
|
12.4%
21/169 • Number of events 27
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
7.4%
13/176 • Number of events 18
|
1.8%
3/169 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.1%
9/176 • Number of events 15
|
1.8%
3/169 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
36.9%
65/176 • Number of events 123
|
3.0%
5/169 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Uticaria
|
5.1%
9/176 • Number of events 9
|
4.1%
7/169 • Number of events 8
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of publications that report any results of the study. The sponsor shall have the right to review and comment with respect to proprietary information, data accuracy, and fair balance in compliance with FDA regulations.
- Publication restrictions are in place
Restriction type: OTHER