NCT01220024 is a Phase 2 clinical trial of Bupivacaine Collagen Sponge in Herniorrhaphy, sponsored by Innocoll.

Who is sponsoring NCT01220024?

NCT01220024 is sponsored by Innocoll.

What drugs are being tested in NCT01220024?

Interventions in NCT01220024: Bupivacaine Collagen Sponge, Placebo collagen Sponge.

What condition does NCT01220024 study?

NCT01220024 studies Herniorrhaphy, Postoperative Pain, Inguinal Hernia.

Is NCT01220024 still recruiting?

NCT01220024 is currently completed. Last updated 10 March 2021.

Are results published for NCT01220024?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-03-10 · How we verify

NCT01220024

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 10 March 2021

What this trial tests

Phase 2 trial testing Bupivacaine Collagen Sponge in Herniorrhaphy in 50 participants. Completed in 18 May 2011.

Timeline

2 December 2010

Primary endpoint
18 May 2011

18 May 2011

Quick facts

Lead sponsor	Innocoll
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	50
Start date	2 December 2010
Primary completion	18 May 2011
Estimated completion	18 May 2011
Sites	1 location across United States

Drugs / interventions tested

Bupivacaine Collagen Sponge — full drug profile →
Placebo collagen Sponge — full drug profile →

Conditions studied

Herniorrhaphy — all drugs for Herniorrhaphy →
Postoperative Pain — all drugs for Postoperative Pain →
Inguinal Hernia — all drugs for Inguinal Hernia →

Sponsor

Innocoll — full company profile →

Who can join

18 and older, male only, with Herniorrhaphy or Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores. Primary · 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.

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.

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	2810.4	± 1693.43
2, Placebo Collagen Sponges	3484.5	± 1806.68

Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) Secondary · 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.

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.

1 to 24 hours

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	996.3	± 503.65
2, Placebo Collagen Sponges	1270.4	± 566.52

25 to 48 hours

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	1021.8	± 604.71
2, Placebo Collagen Sponges	1186.7	± 647.40

1 to 48 hours

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	2018.2	± 1092.85
2, Placebo Collagen Sponges	2457.2	± 1155.63

49 to 72 hours

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	792.2	± 633.88
2, Placebo Collagen Sponges	1027.4	± 713.60

Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest Secondary · 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.

1 to 24 hours

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	741.6	± 452.29
2, Placebo Collagen Sponges	856.6	± 486.95

25 to 48 hours

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	754.7	± 538.41
2, Placebo Collagen Sponges	677.2	± 455.96

1 to 48 hours

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	1496.4	± 978.74
2, Placebo Collagen Sponges	1533.8	± 875.52

49 to 72 hours

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	567.0	± 565.64
2, Placebo Collagen Sponges	501.3	± 451.92

1 to 72 hours

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	2063.4	± 1511.89
2, Placebo Collagen Sponges	2035.0	± 1271.12

Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) Secondary · 1,2,4,6,8,10,12,24,48 and 72 hours

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

Hour 1

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	31.4	± 28.59
2, Placebo Collagen Sponges	73.4	± 22.61

Hour 2

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	32.6	± 24.88
2, Placebo Collagen Sponges	60.6	± 22.81

Hour 4

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	31.2	± 26.10
2, Placebo Collagen Sponges	57.0	± 24.79

Hour 6

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	33.2	± 24.95
2, Placebo Collagen Sponges	58.8	± 26.05

Hour 8

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	47.0	± 24.83
2, Placebo Collagen Sponges	54.3	± 27.49

Hour 10

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	43.4	± 25.54
2, Placebo Collagen Sponges	52.0	± 30.41

Hour 12

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	46.7	± 28.18
2, Placebo Collagen Sponges	28.18	± 29.72

Hour 24

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	49.2	± 26.37
2, Placebo Collagen Sponges	51.5	± 26.65

Pain Intensity VAS Scores Over Time at Rest Secondary · 1,2,4,6,8,10,12,24,48 and 72 hours

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

Hour 1

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	31.6	± 29.20
2, Placebo Collagen Sponges	73.4	± 22.61

Hour 2

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	33.2	± 25.20
2, Placebo Collagen Sponges	60.6	± 22.81

Hour 4

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	31.6	± 24.60
2, Placebo Collagen Sponges	57.0	± 24.79

Hour 6

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	33.5	± 25.45
2, Placebo Collagen Sponges	58.8	± 26.05

Hour 8

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	47.3	± 25.33
2, Placebo Collagen Sponges	54.3	± 27.49

Hour 10

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	44.0	± 25.93
2, Placebo Collagen Sponges	52.0	± 30.41

Hour 12

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	47.6	± 28.47
2, Placebo Collagen Sponges	55.2	± 29.72

Hour 24

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	49.3	± 26.92
2, Placebo Collagen Sponges	51.5	± 26.65

Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement Secondary · 1,2,4,6,8,10,12,24,48 and 72 hours

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.

1 to 24 hours

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	40.6	± 13.64
2, Placebo Collagen Sponges	45.6	± 13.84

1 to 48 hours

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	83.3	± 29.63
2, Placebo Collagen Sponges	90.2	± 27.86

1 to 72 hours

Group	Value	95% CI
2, 5x5cm Bupivacaine Collagen Sponges	118.9	± 44.80
2, Placebo Collagen Sponges	128.8	± 46.12

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

2, 5x5cm Bupivacaine Collagen Sponges

Serious: 0/25 (0%)

Deaths: 0/25

2, Placebo Collagen Sponges

Serious: 0/25 (0%)

Deaths: 0/25

Other adverse events (8 terms — click to expand)

Reaction	System	2, 5x5cm Bupivacaine Colla…	2, Placebo Collagen Sponges
Nausea	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Scrotal swelling	Reproductive system and breast disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Dizziness	Nervous system disorders	—	—
Chills	General disorders	—	—
Pyrexia	General disorders	—	—
Incision site infection	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT01220024 adverse events section.

Sponsor's own description

This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Clinical evaluation of XaraColl(®), a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies.
Cusack SL, Jaros M, Kuss M, Minkowitz HS, et al · · 2012 · cited 15× · PMID 22792007 · DOI 10.2147/jpr.s33453

Verify or expand the search:

Other trials of Bupivacaine Collagen Sponge

Trials testing the same drug.

NCT00661466 — Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery · Phase 2 · terminated
NCT00626886 — Efficacy, Safety and Pharmacokinetic Profile of a Collagen Bupivacaine Implant in Men After Open Mesh Herniorrhaphy · Phase 2 · completed

Other recruiting trials for Herniorrhaphy

Currently open trials in the same condition.

NCT06894420 — Comparison the Analgesic Efficacy of Ultrasonographic Bilateral TAP and Anesthetic Infiltration Into the Surgery Field f · NA · recruiting

Other Innocoll trials

Trials by the same sponsor.

NCT04785625 — Efficacy and Safety Study of Postsurgical Analgesia With INL-001 in Abdominoplasty · Phase 3 · completed
NCT04785638 — An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries · Phase 3 · completed
NCT03262688 — Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair · Phase 3 · unknown
NCT03234374 — Pharmacokinetics, Relative Bioavailability and Safety of INL-001 Compared to Marcaine After Open Hernioplasty · Phase 1 · completed
NCT02525133 — Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01220024 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Innocoll
Last refreshed: 10 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01220024.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01220024

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Bupivacaine Collagen Sponge

Other recruiting trials for Herniorrhaphy

Other Innocoll trials

Verify against primary sources