Free Newsletter
Register for our Free Newsletters
Newsletter
Zones
Analysis, Inspection and Laboratory
LeftNav
Assisted/Independent Living
LeftNav
Clinical and Nursing Equipment
LeftNav
Design and Manufacture of Medical Equipment
LeftNav
Diagnostics Equipment, Monitoring and Test
LeftNav
Education, Training and Professional Services
LeftNav
Health Education and Patient Management
LeftNav
Health Estates Management
LeftNav
Healthcare Support and Information Services
LeftNav
Hygiene and Infection Control
LeftNav
IT and Communications in Healthcare
LeftNav
Materials
LeftNav
Medical Device Technology
LeftNav
Research and Development
LeftNav
Safety and Security
LeftNav
View All
Other Carouselweb publications
Carousel Web
Defense File
New Materials
Pro Health Zone
Pro Health Zone
Pro Security Zone
Web Lec
Pro Engineering Zone
 
 
News

First of three phase 2 clinical trials studies analgesic effect of surgical implant

Innocoll Technologies : 11 August, 2008  (Company News)
The last patient has been dosed in the first of three ongoing phase 2 clinical trials sponsored by Innocoll’s wholly owned subsidiary, Innocoll Technologies, to investigate CollaRx Bupivacaine Surgical Implant for the management of post-operative pain.
Innocoll's Bupivacaine Surgical Implant is a biodegradable and fully bioresorbable matrix of purified fibrillar collagen impregnated with the local anaesthetic, bupivacaine, which has been specifically developed and formulated using Innocoll's proprietary CollaRx sponge technology. The Implant is under development in the USA and Europe for the management of post-operative pain following moderate/major abdominal, gynaecological, abdominal, thoracic, and orthopaedic surgeries.

Post-operative pain is typically controlled with narcotic analgesics such as morphine, but systemic administration of these drugs can result in unfavorable side effects including suppression of breathing, sedation, nausea and vomiting, and can also affect patient recovery. Innocoll's Bupivacaine Surgical Implant is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery. The collagen matrix naturally biodegrades over a few days and the bupivacaine is released to provide local analgesia for up to 96 hours post-operatively.

A key feature of Innocoll's product is the ability to Implant it directly into the surgical cavity and at different layers within the wound, such as across the peritoneal incision and directly below the skin incision, which enables localised treatment of both the incisional and deep, visceral pain components normally associated with moderate and major surgery. The bioresorbable nature of the collagen matrix also offers significant clinical benefits and convenience advantages over ambulatory infusion pumps which can be used to provide continuous, long-term analgesia at the site of a surgical wound.

Innocoll has already completed a phase 2 clinical trial in patients undergoing hysterectomy surgery in the absence of gynaecological cancers at Wexham Park Hospital, Slough, UK. The results of the trial were particularly encouraging, showing evidence of sustained, post-operative analgesia for approximately 96 hours as measured by VAS (visual analogue scale) scores and reduced dependence on systemic morphine administered by PCA (patient-controlled analgesia). The extended analgesic action was achieved despite a low total bupivacaine dose (150mg as the hydrochloride salt), which is well below the allowable daily dose and equivalent to that used by some practitioners for a once-off wound infiltration with bupivacaine solution prior to wound closure.

Innocoll has appointed Premier Research Group, a leading clinical research organization in acute and chronic pain, to co-ordinate a series of US phase 2 multi-centred, controlled clinical trials in a variety of surgical procedures; including hysterectomy, herniorrhaphy, and open gastrointestinal surgery. In addition to those surgeries currently being studied, other procedures where the product could potentially be used routinely include caesarean section, mastectomy, cholecystectomy, open heart surgery, vascular surgery, and various orthopaedic surgeries such as hip and knee replacement, bunionectomy, open fracture repair and certain bone Graft procedures.

The trial, the first of three ongoing multi-centred trials to complete patient enrollment, is a 3-way study comparing the analgesic effect of Bupivacaine Surgical Implant versus placebo and standard of care in patients undergoing total abdominal hysterectomy.

Dr Michael Myers, Innocoll's president and chief executive officer commented, 'We are delighted to have enrolled the last patient in this phase 2 trial and we are now eagerly anticipating the full and final results in approximately three months. In the meantime, we are working diligently through our other ongoing and planned phase 2 and phase 3 clinical trials to support the development of our three leading product opportunities in post-operative pain, prevention of surgical site infection, and treatment of diabetic foot infection.'
Bookmark and Share
 
Home I Editor's Blog I News by Zone I News by Date I News by Category I Special Reports I Directory I Events I Advertise I Submit Your News I About Us I Guides
 
   © 2012 ProHealthServiceZone.com
Netgains Logo