Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant (NCT NCT04418466)
NCT ID: NCT04418466
Last Updated: 2024-12-27
Results Overview
Number of Participants with Treatment-Emergent Adverse Events.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Up to 8 months and up to 15 months for groups 1 and 2 respectively.
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
DLP-114 Alpha-4 (6-months)
Group 1: 6-month implant arm
Oral Phase: 3mg of Risperidone for 2 weeks
Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months
|
DLP-114 Alpha-7 (12-months)
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
Started Implant Phase
|
14
|
14
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant
Baseline characteristics by cohort
| Measure |
DLP-114 Alpha-4 (6-months)
n=14 Participants
Group 1: 6-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months
|
DLP-114 Alpha-7 (12-months)
n=14 Participants
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
54.5 Years
n=5 Participants
|
54.5 Years
n=7 Participants
|
54.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 8 months and up to 15 months for groups 1 and 2 respectively.Population: All patients participating in both phases of the study (Oral and implant).
Number of Participants with Treatment-Emergent Adverse Events.
Outcome measures
| Measure |
DLP-114 Alpha-4 (6-months)
n=14 Participants
Group 1: 6-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months
|
DLP-114 Alpha-7 (12-months)
n=14 Participants
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
|
|---|---|---|
|
Adverse Events
|
10 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 6 months and 12 months for groups 1 and 2 respectively.Population: Participants who enrolled in the implant phase of the study,
Evaluate the incidence of local site reactions. Percentage of implant site assessments with a dermal irritation scale rating greater than zero (rating scale is 0 to 4, where 0 indicates no erythema or edema, and 4 indicates erythema or slight eschar).
Outcome measures
| Measure |
DLP-114 Alpha-4 (6-months)
n=298 Implant site assessments
Group 1: 6-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months
|
DLP-114 Alpha-7 (12-months)
n=409 Implant site assessments
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
|
|---|---|---|
|
Percentage of Implant Site Assessments With a Dermal Irritation Scale Rating Greater Than Zero
|
10.1 percentage of site assessments rated >0
|
5.1 percentage of site assessments rated >0
|
PRIMARY outcome
Timeframe: 6 months and 12 months for groups 1 and 2 respectively.Population: Patients who started the implant phase
Number of participants who experienced an Adverse Events related to Implantation or Explantation Procedures
Outcome measures
| Measure |
DLP-114 Alpha-4 (6-months)
n=14 Participants
Group 1: 6-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months
|
DLP-114 Alpha-7 (12-months)
n=14 Participants
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
|
|---|---|---|
|
Number of Participants Who Experienced an AE Related to Implantation or Explantation Procedures
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: t=0, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours following oral administration.Population: Participants who completed the Oral Dose Phase and began the Implant Phase.
Oral Phase Cave: Average plasma concentration of active moiety (risperidone + 9 OH risperidone) during 24 hours after 3 days of repeated 3mg QD oral administrations
Outcome measures
| Measure |
DLP-114 Alpha-4 (6-months)
n=140 Plasma Measurement
Group 1: 6-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months
|
DLP-114 Alpha-7 (12-months)
n=140 Plasma Measurement
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
|
|---|---|---|
|
Oral Phase Cave: Average Plasma Concentration of Active Moiety (Risperidone + 9 OH Risperidone) During 24 Hours After 3 Days of Repeated 3mg QD Oral Administrations
|
43.07 ng/mL
Standard Deviation 13.32
|
43.86 ng/mL
Standard Deviation 14.12
|
SECONDARY outcome
Timeframe: PK blood draw & analysis were performed per protocol time intervals; 0, 1, 2, 3, 4, 6, 8, 12, 24, 28, 32, 36, 48, and 52 hours post-placement of implants; 1x/day for 4 additional days, 1x/week during days 5-28; biweekly until day of device removal.Population: Participants who completed the study.
Average plasma concentration of active moiety (risperidone + 9 OH risperidone) following switch from oral risperidone to subcutaneous implantation of two DLP-114 devices at specific time intervals per protocol for 6 months or 12 months (groups 1 and 2 respectively).
Outcome measures
| Measure |
DLP-114 Alpha-4 (6-months)
n=361 Plasma Measurement
Group 1: 6-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months
|
DLP-114 Alpha-7 (12-months)
n=459 Plasma Measurement
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
|
|---|---|---|
|
Implant Cave: Average Plasma Concentration of Active Moiety (Risperidone + 9 OH Risperidone) During the Implant Phase
|
11.54 ng/ML
Standard Deviation 3.99
|
14.41 ng/ML
Standard Deviation 6.76
|
SECONDARY outcome
Timeframe: For group 1: Screening period, day -1, day 84, day 183; and for Group 2: Screening period, day -1, day 84, day 182, day 280, day 364.Population: Participants who completed the study.
Average Positive and Negative Syndrome Scale (PANSS) during the study (Oral \& Implant Phases). The average PANSS score was calculated for each participant during the study. The PANSS score reported is the average of all participants who completed the study in each group. The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology)
Outcome measures
| Measure |
DLP-114 Alpha-4 (6-months)
n=48 Individual PANSS Score Assessment
Group 1: 6-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months
|
DLP-114 Alpha-7 (12-months)
n=66 Individual PANSS Score Assessment
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
|
|---|---|---|
|
Average Positive and Negative Syndrome Scale (PANSS) During the Study (Oral & Implant Phases)
|
56.92 Total score on PANSS scale
Standard Deviation 7.55
|
57.51 Total score on PANSS scale
Standard Deviation 8.43
|
SECONDARY outcome
Timeframe: CGI-I assessments were conducted over the course of the study per the protocol schedule of assessments. For Group 1: day 7, 14, 28, 42, 70, 112,140, 68, 183 and for Group 2: day 7, 14, 28, 56, 84, 112,140, 168,182, 210, 238, 252, 280, 308, 336, 350, 364.Population: Participants who completed the study
Average Clinical Global Impression-Improvement (CGI-I) Scale during the Implant Phase. The average CGI-I score was calculated for each participant during the Implant Phase. The CGI-I score reported is the average of all participants who completed the study in each group. The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Outcome measures
| Measure |
DLP-114 Alpha-4 (6-months)
n=108 Individual CGI-I Assessment
Group 1: 6-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months
|
DLP-114 Alpha-7 (12-months)
n=181 Individual CGI-I Assessment
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
|
|---|---|---|
|
Average Clinical Global Impression-Improvement (CGI-I) Scale During the Implant Phase
|
3.5 Score on CGI-I scale
Interval 1.0 to 5.0
|
3.7 Score on CGI-I scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 6-months and 12-months for groups 1 and 2 respectively. Remaining Risperidone measurements taken at the end of the Implant Phase.Population: Participants who completed the study.
Average daily Risperidone Implant output during the Implant Phase. Average daily output is calculated by using the amount of Risperidone drug substance remaining in the DLP-114 reservoir following removal. The average daily output is calculated for each participant by using the two devices that each participant received. Risperidone output reported as the average for each group.
Outcome measures
| Measure |
DLP-114 Alpha-4 (6-months)
n=24 Implant Devices
Group 1: 6-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months
|
DLP-114 Alpha-7 (12-months)
n=22 Implant Devices
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
|
|---|---|---|
|
Average Daily Risperidone Implant Output During the Implant Phase
|
0.676 mg/day
Standard Deviation 0.156
|
0.531 mg/day
Standard Deviation 0.106
|
SECONDARY outcome
Timeframe: Group 1 (6-month): Ultrasound on days 14 and 183. Group 2 (12-month): Ultrasound on days 14 and 364.Population: Participants who completed the study
Average depth of implant device placement measured by ultrasound in mm. The average depth was calculated for each participant. The implant device depth reported is the average of all participants who completed the study in each group.
Outcome measures
| Measure |
DLP-114 Alpha-4 (6-months)
n=24 Implant Devices
Group 1: 6-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months
|
DLP-114 Alpha-7 (12-months)
n=22 Implant Devices
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
|
|---|---|---|
|
Implant Device Placement Depth
|
4.10 mm
Standard Deviation 1.84
|
4.85 mm
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: Group 1 (6-month): Assessments performed day 1 and day 183. Group 2 (12-month): Assessments performed day 1 and 364.Population: Participants who completed the study.
Implant migration is defined as a distance of greater than 3cm between the initial incision and the proximal end of the implant device prior to removal.
Outcome measures
| Measure |
DLP-114 Alpha-4 (6-months)
n=12 Participants
Group 1: 6-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (360 mg of Risperidone per implant) for 6 months
|
DLP-114 Alpha-7 (12-months)
n=11 Participants
Group 2: 12-month implant arm
Oral Phase: 3 mg of Risperidone for 2 weeks
Implant Phase: 2 implants (435 mg of Risperidone per implant) for 12 months
|
|---|---|---|
|
Number of Participants Who Experienced Implant Migration in at Least One of the Implanted Devices
|
0 number of participants
|
0 number of participants
|
Adverse Events
DLP-114 Alpha-4 (6-months)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
DLP-114 Alpha-7 (12-months)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DLP-114 Alpha-4 (6-months)
n=14 participants at risk
2 360mg Risperidone Implants
Risperidone: Risperidone Implant
|
DLP-114 Alpha-7 (12-months)
n=14 participants at risk
2 435mg Risperidone Implants
Risperidone: Risperidone Implant
|
|---|---|---|
|
General disorders
Oedema Peripheral
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Investigations
Weight Increase
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
Other adverse events
| Measure |
DLP-114 Alpha-4 (6-months)
n=14 participants at risk
2 360mg Risperidone Implants
Risperidone: Risperidone Implant
|
DLP-114 Alpha-7 (12-months)
n=14 participants at risk
2 435mg Risperidone Implants
Risperidone: Risperidone Implant
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.3%
2/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
General disorders
Implant site haemorrhage
|
7.1%
1/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
General disorders
Injection Site Scar
|
7.1%
1/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
General disorders
Implant site pain
|
14.3%
2/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
14.3%
2/14 • Number of events 4 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
21.4%
3/14 • Number of events 5 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.4%
3/14 • Number of events 4 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Nervous system disorders
Somnolence
|
14.3%
2/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
General disorders
Chest Pain
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
7.1%
1/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
7.1%
1/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Investigations
Weight increased
|
21.4%
3/14 • Number of events 5 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
General disorders
Implant Site pruritus
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
General disorders
Injection site discomfort
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
14.3%
2/14 • Number of events 4 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Gastrointestinal disorders
Paresthesia Oral
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Injury, poisoning and procedural complications
Contusion
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Gastrointestinal disorders
Toothache
|
7.1%
1/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
2/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Metabolism and nutrition disorders
Increased appetite
|
14.3%
2/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Infections and infestations
Ear infection
|
7.1%
1/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Psychiatric disorders
Abnormal behavior
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Cardiac disorders
Tachycardia
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Infections and infestations
Gastroenteritis
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Blood and lymphatic system disorders
Polycythaemia
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
1/14 • Number of events 2 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Respiratory, thoracic and mediastinal disorders
Testicular pain
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
|
Infections and infestations
Hordeolum
|
7.1%
1/14 • Number of events 3 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
0.00%
0/14 • Group 1 (6-month implant group): Up to 8-months (Includes oral phase, implant phase, and follow up). Group 2 (12-month implant group): Up to 15-months (Includes oral phase, implant phase, and follow up).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place