Trial Outcomes & Findings for Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density (NCT NCT00715676)
NCT ID: NCT00715676
Last Updated: 2010-01-11
Results Overview
Percent change in lumbar spine BMD (relative to baseline) at Week 52
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
157 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2010-01-11
Participant Flow
Subjects were enrolled from 5 March 2007 to 19 December 2007 at 9 centers within the United States.
Participant milestones
| Measure |
Placebo
Placebo soft gel capsules, oral, once daily
|
220 ng of Vitamin D Analog (DP001)
220 ng DP001 soft gel capsules, oral, once daily DP001 is also known as 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3.
|
440 ng DP001
440 ng DP001 soft gel capsules, oral, once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
54
|
53
|
|
Overall Study
COMPLETED
|
43
|
43
|
21
|
|
Overall Study
NOT COMPLETED
|
6
|
11
|
32
|
Reasons for withdrawal
| Measure |
Placebo
Placebo soft gel capsules, oral, once daily
|
220 ng of Vitamin D Analog (DP001)
220 ng DP001 soft gel capsules, oral, once daily DP001 is also known as 2-methylene-19-nor-(20S)-1alpha, 25-dihydroxyvitamin D3.
|
440 ng DP001
440 ng DP001 soft gel capsules, oral, once daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
5
|
21
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
|
Overall Study
Terminated by Sponsor
|
1
|
0
|
0
|
|
Overall Study
Did Not Meet Entry Criteria
|
0
|
0
|
1
|
|
Overall Study
Use of Exclusionary Medication
|
0
|
0
|
1
|
|
Overall Study
Elevated Blood Glucose
|
0
|
1
|
0
|
Baseline Characteristics
Phase 2 Safety and Efficacy Study of a Vitamin D Compound (DP001) in Postmenopausal Women With Low Bone Mineral Density
Baseline characteristics by cohort
| Measure |
Placebo
n=49 Participants
Placebo soft gel capsules, oral, once daily
|
220 ng DP001
n=54 Participants
220 ng DP001 soft gel capsules, oral, once daily
|
440 ng DP001
n=53 Participants
440 ng DP001 soft gel capsules, oral, once daily
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
61.1 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 5.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.
Percent change in lumbar spine BMD (relative to baseline) at Week 52
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo soft gel capsules, oral, once daily
|
220 ng DP001
n=54 Participants
220 ng DP001 soft gel capsules, oral, once daily
|
440 ng DP001
n=53 Participants
440 ng DP001 soft gel capsules, oral, once daily
|
|---|---|---|---|
|
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52
|
-0.537 Percent change
Standard Deviation 2.545
|
-0.174 Percent change
Standard Deviation 2.820
|
0.309 Percent change
Standard Deviation 3.904
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: This analysis was conducted on the Full Analysis Set, which included all randomized subjects who received at least one dose of study drug. Multiple imputation was used for missing data.
The percent change in hip BMD (relative to baseline) at Week 52
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo soft gel capsules, oral, once daily
|
220 ng DP001
n=54 Participants
220 ng DP001 soft gel capsules, oral, once daily
|
440 ng DP001
n=53 Participants
440 ng DP001 soft gel capsules, oral, once daily
|
|---|---|---|---|
|
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 52
|
-0.315 Percent Change
Standard Deviation 1.894
|
-0.540 Percent Change
Standard Deviation 1.782
|
-0.887 Percent Change
Standard Deviation 1.833
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.
Percent change in femoral neck BMD (relative to baseline) at Week 52
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo soft gel capsules, oral, once daily
|
220 ng DP001
n=54 Participants
220 ng DP001 soft gel capsules, oral, once daily
|
440 ng DP001
n=53 Participants
440 ng DP001 soft gel capsules, oral, once daily
|
|---|---|---|---|
|
Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Week 52
|
-0.428 Percent change
Standard Deviation 2.511
|
-1.085 Percent change
Standard Deviation 3.150
|
-0.680 Percent change
Standard Deviation 2.507
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: This analysis was performed on the Full Analysis Set, which included all subjects who received at least one dose of study drug. Multiple imputation was used for missing data.
Percent change in trochanter BMD (relative to baseline) at Week 52
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo soft gel capsules, oral, once daily
|
220 ng DP001
n=54 Participants
220 ng DP001 soft gel capsules, oral, once daily
|
440 ng DP001
n=53 Participants
440 ng DP001 soft gel capsules, oral, once daily
|
|---|---|---|---|
|
Percent Change From Baseline in Trochanter Bone Mineral Density (BMD) at Week 52
|
-0.375 Percent change
Standard Deviation 2.604
|
-0.341 Percent change
Standard Deviation 2.565
|
-0.941 Percent change
Standard Deviation 2.554
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: This analysis was done for all subjects for whom both baseline and Week 52 data was available.
Change in serum calcium value (relative to baseline) at Week 52
Outcome measures
| Measure |
Placebo
n=43 Participants
Placebo soft gel capsules, oral, once daily
|
220 ng DP001
n=43 Participants
220 ng DP001 soft gel capsules, oral, once daily
|
440 ng DP001
n=21 Participants
440 ng DP001 soft gel capsules, oral, once daily
|
|---|---|---|---|
|
Change From Baseline in Serum Calcium Levels at Week 52
|
-0.06 mg/dL
Standard Deviation 0.268
|
0.11 mg/dL
Standard Deviation 0.286
|
0.29 mg/dL
Standard Deviation 0.243
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Analyses were performed using subjects for whom both Baseline and Week 26 samples were available.
Percent change from baseline at Week 26
Outcome measures
| Measure |
Placebo
n=45 Participants
Placebo soft gel capsules, oral, once daily
|
220 ng DP001
n=45 Participants
220 ng DP001 soft gel capsules, oral, once daily
|
440 ng DP001
n=29 Participants
440 ng DP001 soft gel capsules, oral, once daily
|
|---|---|---|---|
|
Percent Change From Baseline in Serum Bone Markers at Week 26
Osteocalcin
|
3.8 Percent change
Standard Deviation 19.4
|
22.4 Percent change
Standard Deviation 38.0
|
80.3 Percent change
Standard Deviation 73.3
|
|
Percent Change From Baseline in Serum Bone Markers at Week 26
Procollagen type 1 N-propeptide
|
1.0 Percent change
Standard Deviation 29.5
|
11.8 Percent change
Standard Deviation 40.7
|
9.2 Percent change
Standard Deviation 33.4
|
|
Percent Change From Baseline in Serum Bone Markers at Week 26
Serum C-telopeptide cross-links of type 1 collagen
|
4.5 Percent change
Standard Deviation 25.4
|
13.8 Percent change
Standard Deviation 32.4
|
54.5 Percent change
Standard Deviation 54.2
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The participants for this analysis included all randomized subjects who received a dose of study drug.
To assess safety and tolerability, the number of subjects in each treatment group who had one or more adverse events recorded after the beginning of study drug administration were determined.
Outcome measures
| Measure |
Placebo
n=49 Participants
Placebo soft gel capsules, oral, once daily
|
220 ng DP001
n=54 Participants
220 ng DP001 soft gel capsules, oral, once daily
|
440 ng DP001
n=53 Participants
440 ng DP001 soft gel capsules, oral, once daily
|
|---|---|---|---|
|
Number of Subjects With at Least 1 Treatment-emergent Adverse Event
|
41 Participants
|
45 Participants
|
46 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
220 ng DP001
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
440 ng DP001
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=49 participants at risk
Placebo soft gel capsules, oral, once daily
|
220 ng DP001
n=54 participants at risk
220 ng DP001 soft gel capsules, oral, once daily
|
440 ng DP001
n=53 participants at risk
440 ng DP001 soft gel capsules, oral, once daily
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/54 • Number of events 1 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.7%
3/53 • Number of events 3 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
2.0%
1/49 • Number of events 1 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
0.00%
0/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
0.00%
0/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/54 • Number of events 1 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
0.00%
0/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
Other adverse events
| Measure |
Placebo
n=49 participants at risk
Placebo soft gel capsules, oral, once daily
|
220 ng DP001
n=54 participants at risk
220 ng DP001 soft gel capsules, oral, once daily
|
440 ng DP001
n=53 participants at risk
440 ng DP001 soft gel capsules, oral, once daily
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.1%
2/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
3.7%
2/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
7.5%
4/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.1%
3/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
0.00%
0/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
7/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
11.1%
6/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
13.2%
7/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
3/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
3.7%
2/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
15.1%
8/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
7.5%
4/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Infections and infestations
Bronchitis
|
6.1%
3/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
0.00%
0/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
0.00%
0/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Gastrointestinal disorders
Constipation
|
10.2%
5/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.6%
3/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
11.3%
6/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.6%
3/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.2%
5/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.7%
3/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.2%
6/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
9.3%
5/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
3.8%
2/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
0.00%
0/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
7.5%
4/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
General disorders
Fatigue
|
2.0%
1/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.6%
3/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
11.3%
6/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Infections and infestations
Gastroenteritis viral
|
6.1%
3/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Nervous system disorders
Headache
|
8.2%
4/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
13.0%
7/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
17.0%
9/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
3.7%
2/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
24.5%
13/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Renal and urinary disorders
Hypercalciuria
|
0.00%
0/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
13.0%
7/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
22.6%
12/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Vascular disorders
Hypertension
|
8.2%
4/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Infections and infestations
Influenza
|
8.2%
4/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
7.5%
4/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Psychiatric disorders
Insomnia
|
4.1%
2/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.7%
3/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.1%
3/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
3.7%
2/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
9.4%
5/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
3.7%
2/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.7%
3/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Infections and infestations
Nasopharyngitis
|
20.4%
10/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
20.4%
11/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
11.3%
6/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Gastrointestinal disorders
Nausea
|
10.2%
5/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
3.7%
2/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
11.3%
6/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.2%
5/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.6%
3/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.7%
3/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.2%
4/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.6%
3/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.7%
3/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
General disorders
Pyrexia
|
6.1%
3/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
0.00%
0/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Immune system disorders
Seasonal allergy
|
2.0%
1/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.6%
3/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Gastrointestinal disorders
Stomach discomfort
|
8.2%
4/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
0.00%
0/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
5.7%
3/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
3/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
7.5%
4/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Infections and infestations
Urinary tract infection
|
10.2%
5/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
3.7%
2/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
1.9%
1/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
3/49 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
0.00%
0/54 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
3.8%
2/53 • Adverse events were collected for a period of 1 year for subjects completing the study, and through study discontinuation for subjects who discontinued early.
Adverse events were assessed by investigator assessment at subject visits and regular laboratory testing.
|
Additional Information
Hector F. DeLuca, President and Chief Executive Officer
Deltanoid Pharmaceuticals
Phone: 608-238-7710
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60