Trial Outcomes & Findings for Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity (NCT NCT01796548)
NCT ID: NCT01796548
Last Updated: 2013-11-26
Results Overview
Maximal detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. Detrusor pressure is the component of intravesical (in the bladder) pressure that is created by forces in the bladder wall (passive and active). It was estimated by subtracting abdominal pressure from intravesical pressure.
TERMINATED
PHASE4
17 participants
Week 12
2013-11-26
Participant Flow
Participant milestones
| Measure |
Oxybutynin
Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
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Overall Study
STARTED
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17
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Overall Study
Treated
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15
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Oxybutynin
Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
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Overall Study
Lost to Follow-up
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1
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Overall Study
Other
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2
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Baseline Characteristics
Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity
Baseline characteristics by cohort
| Measure |
Oxybutynin
n=15 Participants
Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment. 'Number of participants analyzed for the baseline characteristic was intent-to-treat (ITT) population which included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria.'
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Age Continuous
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52.7 Years
STANDARD_DEVIATION 20.2 • n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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Sex: Female, Male
Male
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12 Participants
n=5 Participants
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Maximal Detrusor Pressure
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57.7 Centimeter of water
STANDARD_DEVIATION 28.1 • n=5 Participants
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PRIMARY outcome
Timeframe: Week 12Population: The Intent-to treat (ITT) population included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria.
Maximal detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. Detrusor pressure is the component of intravesical (in the bladder) pressure that is created by forces in the bladder wall (passive and active). It was estimated by subtracting abdominal pressure from intravesical pressure.
Outcome measures
| Measure |
Oxybutynin
n=15 Participants
Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
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Maximal Detrusor Pressure
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42.8 Centimeter of water
Standard Deviation 29.7
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SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population.
MCC represents the maximum volume of urine the bladder holds.
Outcome measures
| Measure |
Oxybutynin
n=15 Participants
Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
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Maximal Cystometric Capacity (MCC)
Baseline
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169.9 Milliliter (ml)
Standard Deviation 55.2
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Maximal Cystometric Capacity (MCC)
Week 12
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268.8 Milliliter (ml)
Standard Deviation 150.6
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SECONDARY outcome
Timeframe: Baseline and Week 12Population: Data for this outcome measure is not reported because the data was not collected and included in Case Report Form (CRF).
Detrusor leakpoint pressure is the level of pressure at which leakage of urine through the urethra occurs as the bladder fills without an increase in abdominal pressure. This was a measure of both strength of the urethral sphincters and compliance of the detrusor muscle.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for this measure at a particular time point.
Post-void residual urine volume is the amount of urine remaining in the bladder after void completion.
Outcome measures
| Measure |
Oxybutynin
n=7 Participants
Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
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Post-Void Residual Urine Volume
Baseline (n= 7)
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112.1 Milliliter (ml)
Standard Error 79.8
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Post-Void Residual Urine Volume
Week 12 (n= 4)
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184.5 Milliliter (ml)
Standard Error 108.1
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SECONDARY outcome
Timeframe: Baseline and Week 12Population: Data for this outcome measure is not reported because the data was not collected and included in Case Report Form (CRF).
Reflex volume is the infused volume that induces the first detrusor contraction.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: ITT population. Here "n" signifies participants who were evaluable for this measure at a particular time point.
Urge incontinence episodes were reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency with sudden feeling to go to toilet.
Outcome measures
| Measure |
Oxybutynin
n=14 Participants
Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
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Urge Incontinence Episodes
Baseline (n=14)
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8.8 Episodes
Standard Deviation 11.0
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Urge Incontinence Episodes
Week 4 (n=13)
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5.0 Episodes
Standard Deviation 11.4
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Urge Incontinence Episodes
Week 12 (n=13)
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4.9 Episodes
Standard Deviation 11.9
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SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: ITT population. Here "n" signifies participants who were evaluable for this measure at a particular time point. This study is early terminated and there were some missing data for total incontinence which lead to decrease value of total incontinence.
Episodes of total urinary incontinence were reported. Urinary incontinence is the complaint of any involuntary leakage of urine.
Outcome measures
| Measure |
Oxybutynin
n=14 Participants
Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
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Total Incontinence Episodes
Baseline (n=14)
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7.4 Episodes
Standard Deviation 10.7
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Total Incontinence Episodes
Week 4 (n=13)
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4.2 Episodes
Standard Deviation 11.5
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Total Incontinence Episodes
Week 12 (n=13)
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4.8 Episodes
Standard Deviation 12.0
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SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: Data was not reported for this OM, as data was not analyzed because of change in the planned analysis of the study.
Percentage of participants with no episodes of urge urinary incontinence was reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population. Here "N" signifies participants who were evaluable for this measure.
King Health Questionnaire assesses the physical and psycho-social aspects of the disease state. It is a self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep or energy, and severity of urinary symptoms). All domains were assessed in a range: 0-100, where 0=best outcome/response and 100=worst outcome or response. Lower scores indicates better outcome or response.
Outcome measures
| Measure |
Oxybutynin
n=14 Participants
Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
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King Health Questionnaire Score
Week 12: Emotions
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41.3 Units on a scale
Standard Deviation 29.7
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King Health Questionnaire Score
Baseline: General Health Perceptions
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53.5 Units on a scale
Standard Deviation 21.6
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King Health Questionnaire Score
Baseline: Impact of Life
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76.1 Units on a scale
Standard Deviation 30.5
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King Health Questionnaire Score
Baseline: Role Limitations
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66.7 Units on a scale
Standard Deviation 36.4
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King Health Questionnaire Score
Baseline: Physical Limitations
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73.8 Units on a scale
Standard Deviation 22.4
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King Health Questionnaire Score
Baseline: Social Limitations
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58.7 Units on a scale
Standard Deviation 29.0
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King Health Questionnaire Score
Baseline: Personal Relationships
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66.7 Units on a scale
Standard Deviation 35.6
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King Health Questionnaire Score
Baseline: Emotions
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57.1 Units on a scale
Standard Deviation 36.1
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King Health Questionnaire Score
Baseline: Sleep or Energy
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51.2 Units on a scale
Standard Deviation 24.9
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King Health Questionnaire Score
Baseline: Incontinence Severity
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44.0 Units on a scale
Standard Deviation 31.3
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King Health Questionnaire Score
Week 12: Role Limitations
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63.1 Units on a scale
Standard Deviation 34.7
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King Health Questionnaire Score
Week 12: Physical Limitations
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66.7 Units on a scale
Standard Deviation 27.7
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King Health Questionnaire Score
Week 12: Social Limitations
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60.7 Units on a scale
Standard Deviation 32.5
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King Health Questionnaire Score
Week 12: General Health Perceptions
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35.7 Units on a scale
Standard Deviation 16.2
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King Health Questionnaire Score
Week 12: Impact of Life
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59.5 Units on a scale
Standard Deviation 29.8
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King Health Questionnaire Score
Week 12: Personal Relationships
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30.9 Units on a scale
Standard Deviation 33.9
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King Health Questionnaire Score
Week 12: Sleep or Energy
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42.9 Units on a scale
Standard Deviation 33.1
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King Health Questionnaire Score
Week 12: Incontinence Severity
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33.9 Units on a scale
Standard Deviation 26.0
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Adverse Events
Oxybutynin
Serious adverse events
| Measure |
Oxybutynin
n=15 participants at risk
Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
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Infections and infestations
Urinary tract infection
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6.7%
1/15 • Baseline up to Week 12
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Other adverse events
| Measure |
Oxybutynin
n=15 participants at risk
Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
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Renal and urinary disorders
Pollakiuria
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6.7%
1/15 • Baseline up to Week 12
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Gastrointestinal disorders
Dry mouth
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73.3%
11/15 • Baseline up to Week 12
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Infections and infestations
Urinary tract infection
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6.7%
1/15 • Baseline up to Week 12
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Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
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6.7%
1/15 • Baseline up to Week 12
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Skin and subcutaneous tissue disorders
Rash
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6.7%
1/15 • Baseline up to Week 12
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Skin and subcutaneous tissue disorders
Pruritis
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6.7%
1/15 • Baseline up to Week 12
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Gastrointestinal disorders
Constipation
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6.7%
1/15 • Baseline up to Week 12
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Vascular disorders
Orthostatic hypotension
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6.7%
1/15 • Baseline up to Week 12
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Gastrointestinal disorders
Nausea
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6.7%
1/15 • Baseline up to Week 12
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Renal and urinary disorders
Cystitis
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6.7%
1/15 • Baseline up to Week 12
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Gastrointestinal disorders
Vomitting
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6.7%
1/15 • Baseline up to Week 12
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Injury, poisoning and procedural complications
Nerve compression
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6.7%
1/15 • Baseline up to Week 12
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Musculoskeletal and connective tissue disorders
Back pain
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6.7%
1/15 • Baseline up to Week 12
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Additional Information
Medical Affairs Director
Medical Affairs, Janssen-Cilag (Thailand)
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor shall have first to present the data of Clinical Trial (CT) without approval from the Institution or PI. If the Institution and PI wish to publish data from CT, a copy of the same must be provided to Sponsor for review at least 60 days prior to submission. No paper with Confidential Information will be submitted with Sponsor's prior written consent. If requested in writing, Institution and PI will withhold publication for up to an additional 60 days to allow filing of patent application.
- Publication restrictions are in place
Restriction type: OTHER