Trial Outcomes & Findings for Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers (NCT NCT00627094)

NCT ID: NCT00627094

Last Updated: 2017-09-15

Results Overview

The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)
• Results posted on: 2017-09-15

Participant Flow

Participant milestones

Measure	Biatain Ibu Biatain foam dressing containing Ibuprofen	Biatain Biatain Foam dressing without ibuprofen - control
Overall Study STARTED	60	60
Overall Study COMPLETED	48	45
Overall Study NOT COMPLETED	12	15

Reasons for withdrawal

Measure	Biatain Ibu Biatain foam dressing containing Ibuprofen	Biatain Biatain Foam dressing without ibuprofen - control
Overall Study Adverse Event	8	7
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	1
Overall Study ulcer healed	1	7
Overall Study Other reason	1	0

Baseline Characteristics

Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

Baseline characteristics by cohort

Measure	Biatain Ibu n=60 Participants Biatain foam dressing containing ibuprofen	Biatain n=60 Participants Biatain foam dressing without ibuprofen - control	Total n=120 Participants Total of all reporting groups
Age, Continuous Age	71.6 YEARS STANDARD_DEVIATION 12.8 • n=5 Participants	69.5 YEARS STANDARD_DEVIATION 12.5 • n=7 Participants	70.6 YEARS STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment France	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Spain	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Denmark	32 participants n=5 Participants	32 participants n=7 Participants	64 participants n=5 Participants
Region of Enrollment Germany	22 participants n=5 Participants	22 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning)

Population: ITT population

The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.

Outcome measures

Measure	Biatain Ibu n=468 Total Number of scores day 1-5 Biatain foam dressing containing ibuprofen	Biatain n=463 Total Number of scores day 1-5 Biatain foam dressing without ibuprofen - control
Pain Relief No Pain Relief	22 percentage of scores within category	31 percentage of scores within category
Pain Relief Slight Pain Relief	26 percentage of scores within category	31 percentage of scores within category
Pain Relief Moderate Pain Relief	30 percentage of scores within category	26 percentage of scores within category
Pain Relief A lot Pain Relief	19 percentage of scores within category	11 percentage of scores within category
Pain Relief Complete Pain Relief	3 percentage of scores within category	1 percentage of scores within category

SECONDARY outcome

Timeframe: Change from baseline in Pain Intensity (PI) on day 4 evening

Population: PP-population (The PP population consisted of all randomized subjects that fulfilled the inclusion/exclusion criteria and which did not violate the protocol in a serious way day 1-5) - Evaluation performed on un-blinded data before database lock.

Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain).

Outcome measures

Measure	Biatain Ibu n=60 Participants Biatain foam dressing containing ibuprofen	Biatain n=60 Participants Biatain foam dressing without ibuprofen - control
Pain Intensity (PI) Change	2.2 Change in PI since baseline Standard Deviation 2.2	1.9 Change in PI since baseline Standard Deviation 2.4

SECONDARY outcome

Timeframe: Change from baseline to end of trial (day 43)

Population: ITT population

Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement)

Outcome measures

Measure	Biatain Ibu n=60 Participants Biatain foam dressing containing ibuprofen	Biatain n=60 Participants Biatain foam dressing without ibuprofen - control
Change From Baseline in Ulcer Area	59 Relative change from baseline in percent Standard Deviation 82	50 Relative change from baseline in percent Standard Deviation 60

SECONDARY outcome

Timeframe: Continuously from start of treatment to end of trial (day 43)

Number of Adverse events reported which were evaluated to be related or possible related to the device

Outcome measures

Measure	Biatain Ibu n=60 Participants Biatain foam dressing containing ibuprofen	Biatain n=60 Participants Biatain foam dressing without ibuprofen - control
Adverse Events	4 Number of AE	6 Number of AE

Adverse Events

Biatain Ibu

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Biatain

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Biatain Ibu n=60 participants at risk Biatain foam dressing containing ibuprofen	Biatain n=60 participants at risk Biatain foam dressing without ibuprofen
Gastrointestinal disorders Hospitalisation due to gastritis	0.00% 0/60 • 6 weeks	1.7% 1/60 • 6 weeks

Other adverse events

Measure	Biatain Ibu n=60 participants at risk Biatain foam dressing containing ibuprofen	Biatain n=60 participants at risk Biatain foam dressing without ibuprofen
Skin and subcutaneous tissue disorders Contact dermatitis in the peri-ulcer skin	1.7% 1/60 • 6 weeks	6.7% 4/60 • 6 weeks
Skin and subcutaneous tissue disorders Increased pain in study ulcer	0.00% 0/60 • 6 weeks	3.3% 2/60 • 6 weeks
Skin and subcutaneous tissue disorders Blisters at the edge of the dressing	1.7% 1/60 • 6 weeks	0.00% 0/60 • 6 weeks
Infections and infestations Infection in study ulcer	3.3% 2/60 • 6 weeks	0.00% 0/60 • 6 weeks

Additional Information

Scientific Manager

Coloplast

Phone: +4549113557

Email: dkkg@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60