Trial Outcomes & Findings for Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy (NCT NCT01220024)

NCT ID: NCT01220024

Last Updated: 2021-03-10

Results Overview

The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is "0". Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
• Results posted on: 2021-03-10

Participant Flow

medical investigative sites

Participant milestones

Measure	2, 5x5cm Bupivacaine Collagen Sponges Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge - Two 5 × 5-cm bupivacaine sponges each containing 75 mg of Type I collagen and 100 mg bupivacaine hydrochloride,	2, Placebo Collagen Sponges Placebo collagen Sponge: Drug: Placebo Collagen Sponge - Two 5 × 5-cm placebo sponges each containing 75 mg of Type I collagen.
Overall Study STARTED	25	25
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	2, 5x5cm Bupivacaine Collagen Sponges Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge - Two 5 × 5-cm bupivacaine sponges each containing 75 mg of Type I collagen and 100 mg bupivacaine hydrochloride,	2, Placebo Collagen Sponges Placebo collagen Sponge: Drug: Placebo Collagen Sponge - Two 5 × 5-cm placebo sponges each containing 75 mg of Type I collagen.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy

Baseline characteristics by cohort

Measure	2, 5x5cm Bupivacaine Collagen Sponges n=25 Participants Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge	2, Placebo Collagen Sponges n=25 Participants Placebo collagen Sponge: Drug: Placebo Collagen Sponge	Total n=50 Participants Total of all reporting groups
Age, Continuous	47.8 years STANDARD_DEVIATION 12.3 • n=5 Participants	41.7 years STANDARD_DEVIATION 14.9 • n=7 Participants	44.7 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.

Population: Intent-to-treat population

The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is "0". Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported.

Outcome measures

Measure	2, 5x5cm Bupivacaine Collagen Sponges n=25 Participants Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge	2, Placebo Collagen Sponges n=24 Participants Placebo collagen Sponge: Drug: Placebo Collagen Sponge
Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores.	2810.4 score on a scale*hour Standard Deviation 1693.43	3484.5 score on a scale*hour Standard Deviation 1806.68

SECONDARY outcome

Timeframe: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.

Population: Intent-to-Treat Population

Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours * the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100* the number of hours in that period.

Outcome measures

Measure	2, 5x5cm Bupivacaine Collagen Sponges n=25 Participants Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge	2, Placebo Collagen Sponges n=24 Participants Placebo collagen Sponge: Drug: Placebo Collagen Sponge
Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) 1 to 24 hours	996.3 score on a scale*hour Standard Deviation 503.65	1270.4 score on a scale*hour Standard Deviation 566.52
Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) 49 to 72 hours	792.2 score on a scale*hour Standard Deviation 633.88	1027.4 score on a scale*hour Standard Deviation 713.60
Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) 25 to 48 hours	1021.8 score on a scale*hour Standard Deviation 604.71	1186.7 score on a scale*hour Standard Deviation 647.40
Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) 1 to 48 hours	2018.2 score on a scale*hour Standard Deviation 1092.85	2457.2 score on a scale*hour Standard Deviation 1155.63

SECONDARY outcome

Timeframe: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.

Population: ITT population

Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours * the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100* the number of hours in that period.

Outcome measures

Measure	2, 5x5cm Bupivacaine Collagen Sponges n=25 Participants Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge	2, Placebo Collagen Sponges n=24 Participants Placebo collagen Sponge: Drug: Placebo Collagen Sponge
Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest 25 to 48 hours	754.7 score on a scale*hour Standard Deviation 538.41	677.2 score on a scale*hour Standard Deviation 455.96
Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest 1 to 24 hours	741.6 score on a scale*hour Standard Deviation 452.29	856.6 score on a scale*hour Standard Deviation 486.95
Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest 1 to 48 hours	1496.4 score on a scale*hour Standard Deviation 978.74	1533.8 score on a scale*hour Standard Deviation 875.52
Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest 49 to 72 hours	567.0 score on a scale*hour Standard Deviation 565.64	501.3 score on a scale*hour Standard Deviation 451.92
Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest 1 to 72 hours	2063.4 score on a scale*hour Standard Deviation 1511.89	2035.0 score on a scale*hour Standard Deviation 1271.12

SECONDARY outcome

Timeframe: 1,2,4,6,8,10,12,24,48 and 72 hours

Population: ITT Population

Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. The lower the sore the better the outcome. Higher score is a worse outcome

Outcome measures

Measure	2, 5x5cm Bupivacaine Collagen Sponges n=25 Participants Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge	2, Placebo Collagen Sponges n=24 Participants Placebo collagen Sponge: Drug: Placebo Collagen Sponge
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) Hour 1	31.4 units on a scale Standard Deviation 28.59	73.4 units on a scale Standard Deviation 22.61
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) Hour 2	32.6 units on a scale Standard Deviation 24.88	60.6 units on a scale Standard Deviation 22.81
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) Hour 4	31.2 units on a scale Standard Deviation 26.10	57.0 units on a scale Standard Deviation 24.79
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) Hour 6	33.2 units on a scale Standard Deviation 24.95	58.8 units on a scale Standard Deviation 26.05
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) Hour 8	47.0 units on a scale Standard Deviation 24.83	54.3 units on a scale Standard Deviation 27.49
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) Hour 10	43.4 units on a scale Standard Deviation 25.54	52.0 units on a scale Standard Deviation 30.41
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) Hour 12	46.7 units on a scale Standard Deviation 28.18	28.18 units on a scale Standard Deviation 29.72
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) Hour 24	49.2 units on a scale Standard Deviation 26.37	51.5 units on a scale Standard Deviation 26.65
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) Hour 48	36.0 units on a scale Standard Deviation 27.31	47.2 units on a scale Standard Deviation 29.78
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) Hour 72	29.8 units on a scale Standard Deviation 27.00	38.3 units on a scale Standard Deviation 30.16

SECONDARY outcome

Timeframe: 1,2,4,6,8,10,12,24,48 and 72 hours

Population: ITT population

Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. Lower score is better. Higher score means more pain. Time points are summarized independently

Outcome measures

Measure	2, 5x5cm Bupivacaine Collagen Sponges n=24 Participants Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge	2, Placebo Collagen Sponges n=24 Participants Placebo collagen Sponge: Drug: Placebo Collagen Sponge
Pain Intensity VAS Scores Over Time at Rest Hour 72	30.7 score on a scale Standard Deviation 27.23	38.3 score on a scale Standard Deviation 30.16
Pain Intensity VAS Scores Over Time at Rest Hour 8	47.3 score on a scale Standard Deviation 25.33	54.3 score on a scale Standard Deviation 27.49
Pain Intensity VAS Scores Over Time at Rest Hour 1	31.6 score on a scale Standard Deviation 29.20	73.4 score on a scale Standard Deviation 22.61
Pain Intensity VAS Scores Over Time at Rest Hour 2	33.2 score on a scale Standard Deviation 25.20	60.6 score on a scale Standard Deviation 22.81
Pain Intensity VAS Scores Over Time at Rest Hour 4	31.6 score on a scale Standard Deviation 24.60	57.0 score on a scale Standard Deviation 24.79
Pain Intensity VAS Scores Over Time at Rest Hour 6	33.5 score on a scale Standard Deviation 25.45	58.8 score on a scale Standard Deviation 26.05
Pain Intensity VAS Scores Over Time at Rest Hour 10	44.0 score on a scale Standard Deviation 25.93	52.0 score on a scale Standard Deviation 30.41
Pain Intensity VAS Scores Over Time at Rest Hour 12	47.6 score on a scale Standard Deviation 28.47	55.2 score on a scale Standard Deviation 29.72
Pain Intensity VAS Scores Over Time at Rest Hour 24	49.3 score on a scale Standard Deviation 26.92	51.5 score on a scale Standard Deviation 26.65
Pain Intensity VAS Scores Over Time at Rest Hour 48	36.3 score on a scale Standard Deviation 27.85	47.2 score on a scale Standard Deviation 29.78

SECONDARY outcome

Timeframe: 1,2,4,6,8,10,12,24,48 and 72 hours

Population: ITT population

Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) for each timepoint. (timepoints 1,2,4,6,8,10,12,24,48 and 72 hours ) Patients were asked during multiple time points to provide a score on this VAS scale. For 1 to 24 hours the highest score possible would be 800. For 1 to 48 hours the highest score possible would be 900. For 1 to 72 hours the highest score possible would be 1000. A mean Lower score is better. A mean Higher score is a worse outcome.

Outcome measures

Measure	2, 5x5cm Bupivacaine Collagen Sponges n=25 Participants Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge	2, Placebo Collagen Sponges n=24 Participants Placebo collagen Sponge: Drug: Placebo Collagen Sponge
Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement 1 to 24 hours	40.6 score on a scale Standard Deviation 13.64	45.6 score on a scale Standard Deviation 13.84
Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement 1 to 48 hours	83.3 score on a scale Standard Deviation 29.63	90.2 score on a scale Standard Deviation 27.86
Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement 1 to 72 hours	118.9 score on a scale Standard Deviation 44.80	128.8 score on a scale Standard Deviation 46.12

Adverse Events

2, 5x5cm Bupivacaine Collagen Sponges

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

2, Placebo Collagen Sponges

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	2, 5x5cm Bupivacaine Collagen Sponges n=25 participants at risk Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge	2, Placebo Collagen Sponges n=25 participants at risk Placebo collagen Sponge: Drug: Placebo Collagen Sponge
Gastrointestinal disorders Constipation	24.0% 6/25 • Number of events 6 • 30 days	24.0% 6/25 • Number of events 6 • 30 days
Gastrointestinal disorders Nausea	16.0% 4/25 • Number of events 4 • 30 days	32.0% 8/25 • Number of events 8 • 30 days
Gastrointestinal disorders Vomiting	4.0% 1/25 • Number of events 1 • 30 days	12.0% 3/25 • Number of events 3 • 30 days
General disorders Chills	8.0% 2/25 • Number of events 2 • 30 days	4.0% 1/25 • Number of events 1 • 30 days
General disorders Pyrexia	4.0% 1/25 • Number of events 1 • 30 days	8.0% 2/25 • Number of events 2 • 30 days
Infections and infestations Incision site infection	8.0% 2/25 • Number of events 2 • 30 days	0.00% 0/25 • 30 days
Nervous system disorders Dizziness	4.0% 1/25 • Number of events 1 • 30 days	12.0% 3/25 • Number of events 3 • 30 days
Reproductive system and breast disorders Scrotal swelling	20.0% 5/25 • Number of events 5 • 30 days	12.0% 3/25 • Number of events 3 • 30 days

Additional Information

Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management

Innocoll

Phone: 484-406-5211

Email: ctucker@innocoll.com

Results disclosure agreements

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

Restriction type: OTHER