Trial Outcomes & Findings for Oxandrolone to Heal Pressure Ulcers (NCT NCT00101361)

Last Updated: 2013-12-20

Results Overview

Patients remained in treatment until full healing of the target pressure ulcer (defined as re-epithelialization to a cicatrix with a dry surface and zero open area for a minimum of 96 hours) or 24 weeks, whichever occured first.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

212 participants

Primary outcome timeframe

healing was measured from randomization to full healing or 24 weeks, whichever occured first.

Results posted on

2013-12-20

Participant Flow

enrollment started 08/01/2005 and ended 10/10/2008 at 15 VA Medical Centers. Subjects were randomized only after a four week screening phase.

Potential participants were screened for four weeks to determine eligibility based on documentation of a difficult-to-heal or worsening status of the pressure ulcer as an inpatient.

Participant milestones

Participant milestones
Measure	1 Oxandrolone oxandrolone - two 5mg capsules twice daily	2 Placebo placebo - two capsules twice daily
Overall Study STARTED	108	104
Overall Study COMPLETED	108	104
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oxandrolone to Heal Pressure Ulcers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxandrolone n=108 Participants Oxandrolone	Placebo n=104 Participants placebo	Total n=212 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	82 Participants n=93 Participants	83 Participants n=4 Participants	165 Participants n=27 Participants
Age, Categorical >=65 years	26 Participants n=93 Participants	21 Participants n=4 Participants	47 Participants n=27 Participants
Age, Continuous	58.4 years STANDARD_DEVIATION 10.4 • n=93 Participants	57.3 years STANDARD_DEVIATION 11.6 • n=4 Participants	57.9 years STANDARD_DEVIATION 11.1 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	106 Participants n=93 Participants	104 Participants n=4 Participants	210 Participants n=27 Participants
Region of Enrollment United States	107 participants n=93 Participants	103 participants n=4 Participants	210 participants n=27 Participants
Region of Enrollment Puerto Rico	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants

PRIMARY outcome

Timeframe: healing was measured from randomization to full healing or 24 weeks, whichever occured first.

Outcome measures

Outcome measures
Measure	1 Oxandrolone n=108 Participants oxandrolone - two 5mg capsules twice daily	2 Placebo n=104 Participants placebo - two capsules twice daily
A Healed Pressure Ulcer	26 participants	31 participants

Adverse Events

1 Oxandrolone

Serious events: 9 serious events

Other events: 95 other events

Deaths: 0 deaths

2 Placebo

Serious events: 16 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1 Oxandrolone n=108 participants at risk oxandrolone - two 5mg capsules twice daily	2 Placebo n=104 participants at risk placebo - two capsules twice daily
Neoplasms benign, malignant and unspecified (incl cysts and polyps) oral cancer	0.00% 0/108 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	0.96% 1/104 • Number of events 1 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Gastrointestinal disorders small bowel obstruction, renal failure	0.00% 0/108 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	0.96% 1/104 • Number of events 1 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Surgical and medical procedures elective bladder stone removal	0.93% 1/108 • Number of events 1 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	0.00% 0/104 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Surgical and medical procedures myocutaneous flap surgery	4.6% 5/108 • Number of events 5 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	8.7% 9/104 • Number of events 9 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Metabolism and nutrition disorders death	0.00% 0/108 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	0.96% 1/104 • Number of events 1 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Respiratory, thoracic and mediastinal disorders death	2.9% 3/104 • Number of events 3 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	2.9% 3/104 • Number of events 3 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Infections and infestations death	0.00% 0/108 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	0.96% 1/104 • Number of events 1 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.

Other adverse events

Other adverse events
Measure	1 Oxandrolone n=108 participants at risk oxandrolone - two 5mg capsules twice daily	2 Placebo n=104 participants at risk placebo - two capsules twice daily
Blood and lymphatic system disorders anemia	15.7% 17/108 • Number of events 17 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	3.8% 4/104 • Number of events 4 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Gastrointestinal disorders constipation or diarrhea	7.4% 8/108 • Number of events 8 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	9.6% 10/104 • Number of events 10 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Investigations elevated liver enzyme levels	32.4% 35/108 • Number of events 35 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	2.9% 3/104 • Number of events 3 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Injury, poisoning and procedural complications fever	15.7% 17/108 • Number of events 17 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	9.6% 10/104 • Number of events 10 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Infections and infestations infection	12.0% 13/108 • Number of events 13 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	8.7% 9/104 • Number of events 9 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Gastrointestinal disorders nausea / vomitting	9.3% 10/108 • Number of events 10 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	9.6% 10/104 • Number of events 10 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Skin and subcutaneous tissue disorders non-Target Pressure Ulcer (TPU) skin ulcer	12.0% 13/108 • Number of events 13 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	7.7% 8/104 • Number of events 8 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Infections and infestations osteomylitis	4.6% 5/108 • Number of events 5 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	5.8% 6/104 • Number of events 6 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Infections and infestations pneumonia	13.0% 14/108 • Number of events 14 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	5.8% 6/104 • Number of events 6 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Skin and subcutaneous tissue disorders skin rash / complication	13.9% 15/108 • Number of events 15 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	9.6% 10/104 • Number of events 10 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.
Infections and infestations urinary tract infection	34.3% 37/108 • Number of events 37 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.	26.9% 28/104 • Number of events 28 • years, 5 months Adverse events were reported for each event not each subject, therefore participants could have one or more events. The total events as reported is expected to surpass the total participants. The total participants with at least one adverse event (AE) is 95 oxandrolone and 85 placebo.

Additional Information

William A. Bauman, M.D.

James J. Peters VA Medical Center

Phone: 718-584-9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place