Trial Outcomes & Findings for Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss (NCT NCT00637572)
NCT ID: NCT00637572
Last Updated: 2017-10-05
Results Overview
Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Baseline (Day 1) to Week 12
Results posted on
2017-10-05
Participant Flow
Participant milestones
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
29
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Illicit Drug Use
|
1
|
0
|
Baseline Characteristics
Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss
Baseline characteristics by cohort
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
n=32 Participants
Subjects were treated with 575 mg per as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=31 Participants
Subjects were treated with 800 mg per as single-dose for 12 weeks
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 7.32 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 7.22 • n=7 Participants
|
36.8 years
STANDARD_DEVIATION 7.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit
Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment
Outcome measures
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
n=32 Participants
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=31 Participants
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Change in Body Weight
Overall
|
5.4 kg
Standard Deviation 5.32
|
3.5 kg
Standard Deviation 4.03
|
|
Change in Body Weight
Male
|
7.0 kg
Standard Deviation 3.16
|
3.5 kg
Standard Deviation 4.72
|
|
Change in Body Weight
Female
|
2.3 kg
Standard Deviation 7.18
|
3.5 kg
Standard Deviation 3.42
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.
Outcome measures
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
n=31 Participants
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=31 Participants
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Change From Baseline in Lean Mass
|
2.1 kg
Standard Deviation 3.74
|
1.3 kg
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.
Electrical impedance is a method for body composition assessment. The procedure involves sending a small current through the body and measuring the resistance in ohm. High resistance is associated with smaller amounts of fat-free mass. Smaller resistance is associated with large amounts of fat-free mass.
Outcome measures
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
n=31 Participants
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=31 Participants
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Change From Baseline in Impedance
|
21.6 ohms
Standard Deviation 77.2
|
12.2 ohms
Standard Deviation 54.2
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available baseline measurements.
Outcome measures
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
n=31 Participants
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=31 Participants
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Change From Baseline in Body Fat Mass
|
3.2 kg
Standard Deviation 4.1
|
2.2 kg
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects and 29 subjects were analyzed, respectively based on available baseline measurements.
Outcome measures
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
n=31 Participants
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=29 Participants
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Change in Hip Circumference
|
2.5 cm
Standard Deviation 3.7
|
1.8 cm
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 31 subjects were analyzed for the megestrol acetate oral suspension nanocrystal dispersion group based on available data measurements.
Outcome measures
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
n=32 Participants
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=31 Participants
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Change in Waist Circumference
|
7.1 cm
Standard Deviation 4.9
|
5.4 cm
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit
Outcome measures
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
n=32 Participants
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=31 Participants
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Change in Tricep Skinfold
|
1.0 cm
Standard Deviation 2.6
|
1.5 cm
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit
Outcome measures
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
n=32 Participants
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=31 Participants
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Change in Mid-arm Circumference
|
-0.6 cm
Standard Deviation 11.5
|
1.1 cm
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 12Population: Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 27 subjects and 22 subjects were analyzed, respectively based on available baseline data.
Food intake was quantified by the 24-hour recall food diary
Outcome measures
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
n=27 Participants
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=22 Participants
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Change in Total Energy
|
215.9 kcal
Standard Deviation 830.3
|
150.6 kcal
Standard Deviation 1044.1
|
SECONDARY outcome
Timeframe: Baseline (Day 3) to Week 12Population: Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.
The BACRI instrument is used to measure the benefit of weight gain treatment provided to anorexic patients on health related quality of life aspects. The scale is composed of 9 subscales (0 to 10 \[worse to better\]). The response was captured on a VAS scale in cm. The total BACRI score is the sum with a minimum score 0=worse and maximum score 90=better. These subscales are: change in weight impacting health; concern about weight; appearance change; change feeling of appearance; change in appetite; enjoy eating; overall feeling; benefit of treatment; and quality of life.
Outcome measures
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
n=32 Participants
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=29 Participants
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)
Baseline (Day 3)
|
52.3 cm
Standard Deviation 9.38
|
50.1 cm
Standard Deviation 7.31
|
|
Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)
Week 12
|
67.6 cm
Standard Deviation 9.53
|
65.6 cm
Standard Deviation 14.78
|
SECONDARY outcome
Timeframe: Baseline (Day 3) to Week 12Population: Analysis is based on Intent-To-Treat-Population (ITT); all randomized subjects who were dispensed medication and had at least one post-randomization visit. Only 29 subjects were analyzed in the micronized formulation treatment group based on available baseline measurements.
Appetite was assessed via visual analogue scale (VAS) as part of the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) (Question 5 only). The question was "To what extent has your appetite changed since the start of treatment?" The response was captured on a VAS scale in cm with a range from 0 ( "much worse") to 10 ("much better").
Outcome measures
| Measure |
Megestrol Acetate Oral Suspension Nanocrystal Dispersion
n=32 Participants
Subjects were treated with 575 mg per day as single-dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=29 Participants
Subjects were treated with 800 mg per day as single-dose for 12 weeks
|
|---|---|---|
|
Appetite at Baseline (Day 3) and Week 12
Baseline Day 3
|
6.1 cm
Standard Deviation 1.81
|
5.8 cm
Standard Deviation 1.16
|
|
Appetite at Baseline (Day 3) and Week 12
Week 12
|
8.4 cm
Standard Deviation 1.30
|
8.0 cm
Standard Deviation 2.14
|
Adverse Events
Megestrol Acetate Oral Suspension NanoCrystal Dispersion
Serious events: 14 serious events
Other events: 30 other events
Deaths: 0 deaths
Megestrol Acetate Oral Suspension Micronized Formulation
Serious events: 14 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Megestrol Acetate Oral Suspension NanoCrystal Dispersion
n=32 participants at risk
Subjects were treated with 575 mg per day as single dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=31 participants at risk
Subjects were treated with 800 mg per day as single dose for 12 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Number of events 2 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Cardiac disorders
Cardiac failure congestive
|
3.1%
1/32 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Number of events 2 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Endocrine disorders
Adrenal insufficiency
|
9.4%
3/32 • Number of events 3 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
12.9%
4/31 • Number of events 4 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Endocrine disorders
Adrenal suppression
|
6.2%
2/32 • Number of events 2 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Number of events 2 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
General disorders
Asthenia
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
General disorders
Death of unknown cause
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
General disorders
Oedema peripheral
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Adrenal gland tuberculosis
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Diarrhoea infectious
|
3.1%
1/32 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
HIV infection
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Meningitis tuberculous
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
3.1%
1/32 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Number of events 2 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Blood cortisol abnormal
|
18.8%
6/32 • Number of events 6 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
9.7%
3/31 • Number of events 3 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Blood cortisol decreased
|
6.2%
2/32 • Number of events 2 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Venous pressure jugular increased
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Nervous system disorders
Cerebral infarction
|
3.1%
1/32 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Number of events 1 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • Number of events 2 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
Other adverse events
| Measure |
Megestrol Acetate Oral Suspension NanoCrystal Dispersion
n=32 participants at risk
Subjects were treated with 575 mg per day as single dose for 12 weeks
|
Megestrol Acetate Oral Suspension Micronized Formulation
n=31 participants at risk
Subjects were treated with 800 mg per day as single dose for 12 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.4%
3/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Cardiac disorders
Cardiac failure congestive
|
9.4%
3/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Endocrine disorders
Adrenal insufficiency
|
12.5%
4/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
25.8%
8/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Endocrine disorders
Adrenal suppression
|
12.5%
4/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Endocrine disorders
Cushingoid
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Gastrointestinal disorders
Abdominal distension
|
3.1%
1/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Gastrointestinal disorders
Abdominal pain
|
9.4%
3/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Gastrointestinal disorders
Constipation
|
9.4%
3/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
12.9%
4/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Gastrointestinal disorders
Dyspepsia
|
18.8%
6/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Gastrointestinal disorders
Flatulence
|
9.4%
3/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Gastrointestinal disorders
Gastritis
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Gastrointestinal disorders
Nausea
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
9.7%
3/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
12.9%
4/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
General disorders
Asthenia
|
15.6%
5/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
General disorders
Non-cardiac chest pain
|
3.1%
1/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
9.7%
3/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
General disorders
Oedema peripheral
|
3.1%
1/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
9.7%
3/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
General disorders
Pyrexia
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
12.9%
4/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Bronchitis
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Gastroenteritis
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
9.7%
3/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Pharyngitis
|
3.1%
1/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
12.9%
4/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Infections and infestations
Urinary tract infection
|
9.4%
3/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Injury, poisoning and procedural complications
Excoriation
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Blood cholesterol increased
|
9.4%
3/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Blood cortisol abnormal
|
12.5%
4/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Blood cortisol decreased
|
9.4%
3/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
12.9%
4/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Blood glucose increased
|
3.1%
1/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Blood lactate dehydrogenase increased
|
37.5%
12/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
16.1%
5/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Blood triglycerides increased
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Cardiac murmur
|
9.4%
3/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Low density lipoprotein increased
|
9.4%
3/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Mean cell haemoglobin increased
|
15.6%
5/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
16.1%
5/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Mean cell volume increased
|
25.0%
8/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
16.1%
5/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Red blood cell count decreased
|
15.6%
5/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Red cell distribution width increased
|
28.1%
9/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
16.1%
5/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Investigations
Venous pressure jugular increased
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
12.9%
4/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
1/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
1/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
9.7%
3/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Nervous system disorders
Dizziness
|
3.1%
1/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Nervous system disorders
Headache
|
25.0%
8/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
19.4%
6/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Nervous system disorders
Somnolence
|
3.1%
1/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Nervous system disorders
Tremor
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Psychiatric disorders
Insomnia
|
9.4%
3/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Psychiatric disorders
Libido decreased
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Reproductive system and breast disorders
Amenorrhoea
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.1%
1/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.1%
9/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
19.4%
6/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
4/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
9.7%
3/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
9.4%
3/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
6.5%
2/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Vascular disorders
Flushing
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
0.00%
0/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Vascular disorders
Hypertension
|
15.6%
5/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
16.1%
5/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
|
Vascular disorders
Systolic hypertension
|
6.2%
2/32 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
3.2%
1/31 • Approximately 16 weeks (baseline [day 1] through week 12 plus 30-day follow-up)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All manuscripts, abstracts or other modes of presentation arising from the results of this study must be reviewed and approved in writing by Par, in advance of submission.
- Publication restrictions are in place
Restriction type: OTHER