Dupuytren's Disease
Conditions
Keywords
Dupuytren's nodules
Brief summary
The objectives of this study are to assess the safety and effectiveness of AA4500 in treating palmar Dupuytren's disease nodules.
Detailed description
Approximately 13 sites in the United States and Australia, approximately 90 study subjects. After all pre-injection procedures are completed on day 1, eligible men and women will be randomized in a 1:1:1 ratio to dose group and then in a 4:1 ratio to treatment group. Study drug will be administered into a palmar nodule located on the selected hand. AA4500 (collagenase clostridium histolyticum) 3 doses (low, medium, and high) after reconstitution with sterile diluent (0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride). Each dose of study drug will be injected into the nodule. The injection will be administered in 3 different volumes according to randomization. Placebo after reconstitution with sterile diluent (0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride). Each dose of study drug will be injected into the nodule. The injection will be administered in 3 different volumes according to randomization. Follow up visits for the evaluation of safety and efficacy will be required for all subjects on days 8, 29, and 57.
Interventions
BIOLOGICALCollagenase clostridium histolyticum
Single injection into nodule
BIOLOGICALPlacebo
Single injection into nodule
Sponsors
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provide a signed and dated informed consent 2. Be a man or woman ≥ 18 years of age 3. Have a diagnosis of Dupuytren's disease AND have at least one palmar nodule on the selected hand that is: 1. Palpable 2. Measures between 0.5 cm and 2.0 cm in length and between 0.5 cm and 2.0 cm in width using hand-held calipers n 3. Not directly associated with a Dupuytren's cord 4. Have a negative urine pregnancy test at screening and before injection of study drug and be using a highly effective (ie, \< 1% failure rate) contraception method as judged by the investigator (eg, abstinence, intrauterine device \[IUD\], hormonal \[estrogen/progestin\] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study or be surgically sterile (if female of childbearing potential); or be a postmenopausal female (no menses for at least 1 year or hysterectomy) 5. Be able to comply with the study visit schedule as specified in the protocol
Exclusion criteria
1. Received steroid injections (eg, tri-amcinolone acetonide) on the selected nodule within 3 months before administration of study drug 2. Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands 3. Has a known systemic allergy to collagenase or any other excipient of AA4500 4. Has received any collagenase treatments (eg, Santyl® ointment and/or XIAFLEX®/XIAPEX®) within 30 days before injection of study drug in the hand selected for treatment 5. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for ≤ 150 mg aspirin daily) within 7 days before injection of study drug 6. Has a known recent history of stroke, bleeding, or other medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study 7. Received an investigational drug within 30 days before injection of study drug 8. Is pregnant or intends on becoming pregnant during the study or is breastfeeding a child 9. Has any clinically significant medical history or condition(s), including conditions that affect the hands, that would, in the opinion of the investigator, substantially increase the risk associated with the subject's participation in the protocol or compromise the scientific objectives of the study 10. Had surgery on the selected hand within 3 months before the screening visit 11. Has jewelry on the hand to be treated that cannot be removed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements | Baseline, Day 57 | Percent change from baseline in surface area and volume of the treated nodule was determined from hand-held caliper measurements of the length and width of the nodule. Percent change = 100\*(Day 57 area \[or volume\] - baseline area \[or volume\])/baseline area \[or volume\]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Consistency of the Treated Nodules at Day 57 | Baseline, Day 57 | Investigators determined the consistency of the nodule through palpitation using a 5-point scale: 5 = hard (solid), 4 = firm throughout, 3 = moderate firmness, 2 = soft, and 1 = non-palpable. The change scores could range from +4 (greatest worsening in consistency) to -4 (greatest improvement in consistency); a negative change from baseline value reflects improvement from baseline (softening) while a positive value reflects worsening. |
| Percent Change From Baseline in Hardness of the Treated Nodule at Day 57 | Baseline, Day 57 | A durometer was used to assess nodule hardness on a scale of 0 (soft) to 100 (hard). Percent change = 100\*(Day 57 hardness - baseline hardness)/baseline hardness. A negative value represents the improvement from baseline (softening) while a positive value represents worsening. |
| Change From Baseline in Nodular Pain of the Treated Nodule at Day 57 | Baseline, Day 57 | After the nodule was squeezed using a dynamometer, subjects were asked to rate the amount of pain they felt on an 11-point visual analog scale (VAS) from 0 (no pain or discomfort) to 10 (extreme pain or discomfort). A negative change from baseline value reflects improvement from baseline (less pain) while a positive value reflects worsening. |
| Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound | Baseline, Day 57 | Percent change from baseline in surface area and volume of the treated nodule was determined from ultrasound measurements of the length, width, and depth of the nodule. Percent change = 100\*(Day 57 area \[or volume\] - baseline area \[or volume\])/baseline area \[or volume\]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening. |
| Subject Satisfaction With Treatment | Day 57 | Subjects were asked to rate their satisfaction with treatment on a 5-point scale: 1 = very satisfied, 2 = quite satisfied, 3 = neither satisfied nor dissatisfied, 4 = quite dissatisfied, and 5 = very dissatisfied. |
| Composite Responder Analysis | Day 57 | A composite responder is a subject who had an improved assessment \[values of 1 (very much improved), 2 (much improved), or 3 (minimally improved)\] on the investigator global assessment and had a satisfied assessment \[values of 1 (very satisfied) or 2 (quite satisfied)\] on the subject assessment. |
| Investigator Global Assessment of Improvement With Treatment | Day 57 | Investigators were asked to determine the degree of improvement in the subject's treated nodule compared with screening on a 7-point scale: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. |
Countries
Australia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AA4500 0.60 mg Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule | 18 |
| AA4500 0.40 mg Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule | 18 |
| AA4500 0.25 mg Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule | 22 |
| Placebo Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule | 17 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | AA4500 0.60 mg | AA4500 0.40 mg | AA4500 0.25 mg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 6 Participants | 6 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 12 Participants | 16 Participants | 11 Participants | 52 Participants |
| Age, Continuous | 62.0 years | 60.0 years | 57.0 years | 58.0 years | 58.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 17 Participants | 21 Participants | 16 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 17 Participants | 22 Participants | 17 Participants | 74 Participants |
| Region of Enrollment Australia | 6 participants | 8 participants | 8 participants | 5 participants | 27 participants |
| Region of Enrollment United States | 12 participants | 10 participants | 14 participants | 12 participants | 48 participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 11 Participants | 7 Participants | 34 Participants |
| Sex: Female, Male Male | 12 Participants | 8 Participants | 11 Participants | 10 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 18 | 18 / 18 | 21 / 22 | 7 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 22 | 0 / 17 |
Outcome results
Primary
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements
Percent change from baseline in surface area and volume of the treated nodule was determined from hand-held caliper measurements of the length and width of the nodule. Percent change = 100\*(Day 57 area \[or volume\] - baseline area \[or volume\])/baseline area \[or volume\]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.
Time frame: Baseline, Day 57
Population: Analysis based on Modified Intent-to-Treat (mITT) population; all randomized subjects who received study medication and had pre- and post-baseline nodule measurements for ultrasound and calipers. Analytical outliers (subjects whose percent change in ultrasound volume was greater than the 75th percentile + 3× the interquartile range) were excluded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AA4500 0.60 mg | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements | Surface Area | -81.61 percentage of change | Standard Deviation 20.251 |
| AA4500 0.60 mg | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements | Volume | -89.03 percentage of change | Standard Deviation 15.016 |
| AA4500 0.40 mg | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements | Volume | -87.58 percentage of change | Standard Deviation 16.372 |
| AA4500 0.40 mg | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements | Surface Area | -80.11 percentage of change | Standard Deviation 21.459 |
| AA4500 0.25 mg | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements | Surface Area | -58.30 percentage of change | Standard Deviation 29.849 |
| AA4500 0.25 mg | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements | Volume | -68.15 percentage of change | Standard Deviation 33.859 |
| Placebo | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements | Surface Area | -41.76 percentage of change | Standard Deviation 32.445 |
| Placebo | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements | Volume | -49.13 percentage of change | Standard Deviation 36.736 |
Comparison: For surface areap-value: <0.0001ANOVA
Comparison: For surface areap-value: <0.0001ANOVA
Comparison: For surface areap-value: <0.0001ANOVA
Comparison: For surface areap-value: 0.0713ANOVA
Comparison: For volumep-value: 0.0002ANOVA
Comparison: For volumep-value: 0.0001ANOVA
Comparison: For volumep-value: 0.0001ANOVA
Comparison: For volumep-value: 0.0446ANOVA
Secondary
Change From Baseline in Consistency of the Treated Nodules at Day 57
Investigators determined the consistency of the nodule through palpitation using a 5-point scale: 5 = hard (solid), 4 = firm throughout, 3 = moderate firmness, 2 = soft, and 1 = non-palpable. The change scores could range from +4 (greatest worsening in consistency) to -4 (greatest improvement in consistency); a negative change from baseline value reflects improvement from baseline (softening) while a positive value reflects worsening.
Time frame: Baseline, Day 57
Population: Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AA4500 0.60 mg | Change From Baseline in Consistency of the Treated Nodules at Day 57 | -1.9 units on a scale | Standard Deviation 0.93 |
| AA4500 0.40 mg | Change From Baseline in Consistency of the Treated Nodules at Day 57 | -1.9 units on a scale | Standard Deviation 1.05 |
| AA4500 0.25 mg | Change From Baseline in Consistency of the Treated Nodules at Day 57 | -1.2 units on a scale | Standard Deviation 1.1 |
| Placebo | Change From Baseline in Consistency of the Treated Nodules at Day 57 | -0.3 units on a scale | Standard Deviation 0.96 |
p-value: 0.0002Kruskal-Wallis
p-value: <0.0001Wilcoxon (Mann-Whitney)
p-value: 0.0002Wilcoxon (Mann-Whitney)
p-value: 0.0139Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Nodular Pain of the Treated Nodule at Day 57
After the nodule was squeezed using a dynamometer, subjects were asked to rate the amount of pain they felt on an 11-point visual analog scale (VAS) from 0 (no pain or discomfort) to 10 (extreme pain or discomfort). A negative change from baseline value reflects improvement from baseline (less pain) while a positive value reflects worsening.
Time frame: Baseline, Day 57
Population: Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AA4500 0.60 mg | Change From Baseline in Nodular Pain of the Treated Nodule at Day 57 | -0.8 units on a scale | Standard Deviation 1.97 |
| AA4500 0.40 mg | Change From Baseline in Nodular Pain of the Treated Nodule at Day 57 | -1.6 units on a scale | Standard Deviation 2.21 |
| AA4500 0.25 mg | Change From Baseline in Nodular Pain of the Treated Nodule at Day 57 | -1.7 units on a scale | Standard Deviation 2.57 |
| Placebo | Change From Baseline in Nodular Pain of the Treated Nodule at Day 57 | -0.5 units on a scale | Standard Deviation 1.77 |
p-value: 0.3135ANOVA
p-value: 0.7249ANOVA
p-value: 0.1573ANOVA
p-value: 0.1234ANOVA
Secondary
Composite Responder Analysis
A composite responder is a subject who had an improved assessment \[values of 1 (very much improved), 2 (much improved), or 3 (minimally improved)\] on the investigator global assessment and had a satisfied assessment \[values of 1 (very satisfied) or 2 (quite satisfied)\] on the subject assessment.
Time frame: Day 57
Population: Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AA4500 0.60 mg | Composite Responder Analysis | Responder: Yes | 14 participants |
| AA4500 0.60 mg | Composite Responder Analysis | Responder: No | 4 participants |
| AA4500 0.40 mg | Composite Responder Analysis | Responder: No | 2 participants |
| AA4500 0.40 mg | Composite Responder Analysis | Responder: Yes | 16 participants |
| AA4500 0.25 mg | Composite Responder Analysis | Responder: Yes | 12 participants |
| AA4500 0.25 mg | Composite Responder Analysis | Responder: No | 10 participants |
| Placebo | Composite Responder Analysis | Responder: Yes | 6 participants |
| Placebo | Composite Responder Analysis | Responder: No | 10 participants |
p-value: 0.0065Fisher Exact
p-value: 0.0349Fisher Exact
p-value: 0.0033Fisher Exact
p-value: 0.3423Fisher Exact
Secondary
Investigator Global Assessment of Improvement With Treatment
Investigators were asked to determine the degree of improvement in the subject's treated nodule compared with screening on a 7-point scale: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Time frame: Day 57
Population: Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AA4500 0.60 mg | Investigator Global Assessment of Improvement With Treatment | 1.7 units on a scale | Standard Deviation 0.84 |
| AA4500 0.40 mg | Investigator Global Assessment of Improvement With Treatment | 1.7 units on a scale | Standard Deviation 0.75 |
| AA4500 0.25 mg | Investigator Global Assessment of Improvement With Treatment | 2.5 units on a scale | Standard Deviation 1.1 |
| Placebo | Investigator Global Assessment of Improvement With Treatment | 3.0 units on a scale | Standard Deviation 1.15 |
p-value: 0.0006Kruskal-Wallis
p-value: 0.0014Wilcoxon (Mann-Whitney)
p-value: 0.0012Wilcoxon (Mann-Whitney)
p-value: 0.1298Wilcoxon (Mann-Whitney)
Secondary
Percent Change From Baseline in Hardness of the Treated Nodule at Day 57
A durometer was used to assess nodule hardness on a scale of 0 (soft) to 100 (hard). Percent change = 100\*(Day 57 hardness - baseline hardness)/baseline hardness. A negative value represents the improvement from baseline (softening) while a positive value represents worsening.
Time frame: Baseline, Day 57
Population: Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AA4500 0.60 mg | Percent Change From Baseline in Hardness of the Treated Nodule at Day 57 | -17.05 percentage of change | Standard Deviation 15.584 |
| AA4500 0.40 mg | Percent Change From Baseline in Hardness of the Treated Nodule at Day 57 | -30.40 percentage of change | Standard Deviation 24.93 |
| AA4500 0.25 mg | Percent Change From Baseline in Hardness of the Treated Nodule at Day 57 | -17.87 percentage of change | Standard Deviation 22.265 |
| Placebo | Percent Change From Baseline in Hardness of the Treated Nodule at Day 57 | 4.80 percentage of change | Standard Deviation 23.959 |
p-value: 0.0004ANOVA
p-value: 0.0075ANOVA
p-value: <0.0001ANOVA
p-value: 0.0031ANOVA
Secondary
Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound
Percent change from baseline in surface area and volume of the treated nodule was determined from ultrasound measurements of the length, width, and depth of the nodule. Percent change = 100\*(Day 57 area \[or volume\] - baseline area \[or volume\])/baseline area \[or volume\]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.
Time frame: Baseline, Day 57
Population: Analysis based on mITT population; all randomized subjects who received study medication and had pre- and post-baseline nodule measurements for ultrasound and calipers. Analytical outliers (subjects whose percent change in ultrasound volume was greater than the 75th percentile + 3× the interquartile range) were excluded.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AA4500 0.60 mg | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound | Surface Area | -34.23 percentage of change | Standard Deviation 41.353 |
| AA4500 0.60 mg | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound | Volume | -40.99 percentage of change | Standard Deviation 46.612 |
| AA4500 0.40 mg | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound | Volume | -13.01 percentage of change | Standard Deviation 68.804 |
| AA4500 0.40 mg | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound | Surface Area | -19.37 percentage of change | Standard Deviation 39.658 |
| AA4500 0.25 mg | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound | Surface Area | -10.30 percentage of change | Standard Deviation 41.696 |
| AA4500 0.25 mg | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound | Volume | -9.52 percentage of change | Standard Deviation 60.156 |
| Placebo | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound | Surface Area | -4.54 percentage of change | Standard Deviation 54.784 |
| Placebo | Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound | Volume | -7.19 percentage of change | Standard Deviation 69.877 |
Comparison: For surface areap-value: 0.2431ANOVA
Comparison: For surface areap-value: 0.0625ANOVA
Comparison: For surface areap-value: 0.3409ANOVA
Comparison: For surface areap-value: 0.704ANOVA
Comparison: For volumep-value: 0.3556ANOVA
Comparison: For volumep-value: 0.1275ANOVA
Comparison: For volumep-value: 0.7883ANOVA
Comparison: For volumep-value: 0.9123ANOVA
Secondary
Subject Satisfaction With Treatment
Subjects were asked to rate their satisfaction with treatment on a 5-point scale: 1 = very satisfied, 2 = quite satisfied, 3 = neither satisfied nor dissatisfied, 4 = quite dissatisfied, and 5 = very dissatisfied.
Time frame: Day 57
Population: Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AA4500 0.60 mg | Subject Satisfaction With Treatment | 1.5 units on a scale | Standard Deviation 0.79 |
| AA4500 0.40 mg | Subject Satisfaction With Treatment | 1.6 units on a scale | Standard Deviation 0.85 |
| AA4500 0.25 mg | Subject Satisfaction With Treatment | 2.3 units on a scale | Standard Deviation 1.17 |
| Placebo | Subject Satisfaction With Treatment | 2.8 units on a scale | Standard Deviation 1.34 |
p-value: 0.0048Kruskal-Wallis
p-value: 0.0034Wilcoxon (Mann-Whitney)
p-value: 0.0079Wilcoxon (Mann-Whitney)
p-value: 0.3216Wilcoxon (Mann-Whitney)