Who is sponsoring NCT00749749?

NCT00749749 is sponsored by Innocoll.

What condition does NCT00749749 study?

NCT00749749 studies Pain, Postoperative.

Is NCT00749749 still recruiting?

NCT00749749 is currently completed. Last updated 4 November 2020.

Are results published for NCT00749749?

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

Last reviewed 2020-11-04 · How we verify

NCT00749749

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

Efficacy and Safety of the CollaRx Bupivacaine Implant Compared to the ON-Q Painbuster Following Abdominal Hysterectomy

Completed Phase 2 Results posted Last updated 4 November 2020

What this trial tests

Phase 2 trial testing Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) in Pain, Postoperative in 27 participants. Completed in 22 December 2008.

Timeline

10 September 2008

Primary endpoint
22 December 2008

22 December 2008

Quick facts

Lead sponsor	Innocoll
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	10 September 2008
Primary completion	22 December 2008
Estimated completion	22 December 2008
Sites	1 location across United States

Drugs / interventions tested

Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) — full drug profile →
ON-Q PainBuster Post-op Pain relief System — full drug profile →

Conditions studied

Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Innocoll — full company profile →

Who can join

Adults 18 to 75, female only, with Pain, Postoperative. 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.

Total Amount of Opioid Rescue Analgesia Used Primary · 0 to 24 hours postoperatively

Higher value means worse outcome - Higher number reflects a need for more analgesia - For the first 24 hours after surgery, patients received IV morphine via a PCA pump as rescue analgesia. Patient demand for morphine was recorded. Measurement recorded in total Morphine Milligrams

Group	Value	95% CI
Bupivacaine Collagen Sponge	46.85	± 21.57
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	67.03	± 32.416

Total Amount of Opioid Rescue Analgesia Used Secondary · 0 to 48 hours postoperatively

Higher score means worse outcome - Higher number means more Analgesia was needed. For the first 24 hours after surgery, patients received IV morphine via a PCA pump as rescue analgesia. Patient demand for morphine was recorded. After 24 hours, patients were offered hydrocodone/acetaminophen (maximum could not exceed 8 tablets per 24 hours of the 5/500 mg tablets \[40 mg hydrocodone and 4000 mg acetaminophen\]) or similar medication as determined by the Investigator for pain until discharge. If oral medication was insufficient for control of pain, IM or IV morphine could be administered.

Group	Value	95% CI
Bupivacaine Collagen Sponge	55.43	± 22.770
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	74.85	± 35.381

The Total Amount of Opioid Rescue Analgesia Used Secondary · 0 to 96 hours postoperatively

Higher score means worse outcome. Higher number means more Analgesia was needed. For the first 24 hours after surgery, patients received IV morphine via a PCA pump as rescue analgesia. Patient demand for morphine was recorded. After 24 hours, patients were offered hydrocodone/acetaminophen (maximum could not exceed 8 tablets per 24 hours of the 5/500 mg tablets \[40 mg hydrocodone and 4000 mg acetaminophen\]) or similar medication as determined by the Investigator for pain until discharge. If oral medication was insufficient for control of pain, IM or IV morphine could be administered.

Group	Value	95% CI
Bupivacaine Collagen Sponge	67.87	± 28.175
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	90.77	± 46.114

Total Use of Opioid Rescue Analgesia (mg) Over 0 to 72 Hours Secondary · 0 to 72 Hours

Group	Value	95% CI
Bupivacaine Collagen Sponge	61.98	± 25.27
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	85.36	± 41.887

Time to First Use of Opioid Rescue Analgesia Secondary · 0 to 72 hours

Higher score has a better outcome

Group	Value	95% CI
Bupivacaine Collagen Sponge	0.78	0.43 – 1.02
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	0.57	0.33 – 0.58

VAS Pain Intensity Scores Over Time AT REST Secondary · Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96

For the VAS assessment, patients measured their pain intensity at rest using a horizontal 100-mm VAS scale labeled as follows: No Pain (0 mm) as the left anchor and Worst Pain Imaginable (100 mm) as the right anchor.

Hour 1.0

Group	Value	95% CI
Bupivacaine Collagen Sponge	75.2	± 21.32
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	74.5	± 22.75

Hour 1.5

Group	Value	95% CI
Bupivacaine Collagen Sponge	66.3	± 24.96
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	66.5	± 28.65

Hour 2

Group	Value	95% CI
Bupivacaine Collagen Sponge	61.5	± 26.92
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	68.6	± 26.52

Hour 3

Group	Value	95% CI
Bupivacaine Collagen Sponge	52.2	± 21.71
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	60.9	± 29.85

Hour 6

Group	Value	95% CI
Bupivacaine Collagen Sponge	49.9	± 32.15
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	45.8	± 24.49

Hour 9

Group	Value	95% CI
Bupivacaine Collagen Sponge	38.1	± 29.37
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	35.8	± 24.48

Hour 12

Group	Value	95% CI
Bupivacaine Collagen Sponge	43.6	± 33.33
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	38.9	± 25.87

Hour 18

Group	Value	95% CI
Bupivacaine Collagen Sponge	44.5	± 29.46
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	50.7	± 30.59

VAS (mm) Pain Intensity Scores Over Time (After Cough) Secondary · Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96

For the VAS assessment, patients measured their pain intensity after aggravated movement (cough) using a horizontal 100-mm VAS scale labeled as follows: No Pain (0 mm) as the left anchor and Worst Pain Imaginable (100 mm) as the right anchor.

Hour 1

Group	Value	95% CI
Bupivacaine Collagen Sponge	84.4	± 21.41
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	86.1	± 21.72

Hour 1.5

Group	Value	95% CI
Bupivacaine Collagen Sponge	76.5	± 24.54
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	79.8	± 25.33

Hour 2.0

Group	Value	95% CI
Bupivacaine Collagen Sponge	73.8	± 26.25
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	84.6	± 24.19

Hour 3.0

Group	Value	95% CI
Bupivacaine Collagen Sponge	62.1	± 26.52
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	77.1	± 31.40

hour 6.0

Group	Value	95% CI
Bupivacaine Collagen Sponge	61.9	± 33.51
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	65.8	± 28.50

Hour 9.0

Group	Value	95% CI
Bupivacaine Collagen Sponge	51.5	± 33.07
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	52.5	± 28.08

Hour 12

Group	Value	95% CI
Bupivacaine Collagen Sponge	43.6	± 33.33
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	38.9	± 25.87

Hour 18

Group	Value	95% CI
Bupivacaine Collagen Sponge	44.5	± 29.46
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	50.7	± 30.59

Adverse events — posted to ClinicalTrials.gov

Time frame: Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Bupivacaine Collagen Sponge

Serious: 0/14 (0%)

Deaths: 0/14

ON-ON-Q PainBuster Post-op Pain Relief SystemQ System

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (10 terms — click to expand)

Reaction	System	Bupivacaine Collagen Sponge	ON-ON-Q PainBuster Post-op…
Constipation	Gastrointestinal disorders	—	—
Flatulence	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Headache	Nervous system disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Abdominal distension	Gastrointestinal disorders	—	—
Oedema peripheral	General disorders	—	—
Chills	General disorders	—	—

Data from ClinicalTrials.gov NCT00749749 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether the CollaRx Bupivacaine Implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster Post-op Pain Relief System.

Publications & conference data

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

A randomized, multicenter, pilot study comparing the efficacy and safety of a bupivacaine-collagen implant (XaraColl(®)) with the ON-Q PainBuster(®) Post-op Pain Relief System following open gynecological surgery.
Cusack SL, Minkowitz HS, Kuss M, Jaros M, et al · · 2012 · cited 10× · PMID 23152696 · DOI 10.2147/jpr.s37310

Verify or expand the search:

Other recruiting trials for Pain, Postoperative

Currently open trials in the same condition.

NCT07512141 — Single Versus Double Drains in the Axillary and Pectoral Regions After Modified Radical Mastectomy · NA · recruiting
NCT07354581 — Erector Spinae Plane Block vs Quadro-Iliac Plane Block After Lumbar Instrumentation Surgery · NA · recruiting
NCT07239817 — PENG Block + LIA For Endoprosthesis Surgery With Anterior Approach · NA · recruiting
NCT06740214 — Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty · Phase 3 · recruiting
NCT07057557 — Aloe Vera vs Paraffin Tulle Dressings for Pain Management in Split Thickness Skin Graft Donor Sites · 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 NCT00749749 (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: 4 November 2020

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/NCT00749749.

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