An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy

NCT00993226 | Completed Phase 2 Results

• 1 other identifier: BU-001-IM
• Study Type: interventional
• Target: 115
• Locations: 6 countries
• Sites: 14

Brief Summary

The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on the efficacy and safety of the product.

Conditions

Postoperative Pain

Keywords

Postoperative pain; Local anaesthesia; Postoperative pain after open abdominal hysterectomy surgery

Outcome Measures

Primary Outcomes (2)

• Pain Intensity (PI)

  Pain intensity (PI) on movement AUC over the period 1 to 72 hours post-surgery. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.

  1 to 72 hours post-surgery

• Supplemental Opioid Use

  Cumulative IV morphine-equivalent dose of opioid rescue medication

  0-3 days after surgery

Secondary Outcomes (2)

• Time to First Opioid Rescue Medication Usage

  0-14 days after surgery

• Opioid Related Side Effects

  0-7 days after surgery

Study Arms (6)

SABER-Bupivacaine Treatment 1a

EXPERIMENTAL

double-blind

Drug: SABER-Bupivacaine Treatment 1a

Placebo SABER-Bupivacaine Treatment 1b

PLACEBO COMPARATOR

double-blind

Drug: Placebo SABER-Bupivacaine Treatment 1b

Bupivacaine HCl Treatment 1c

ACTIVE COMPARATOR

double-blind

Drug: Bupivacaine HCl Treatment 1c

SABER-Bupivacaine Treatment 2a

EXPERIMENTAL

double-blind

Drug: SABER-Bupivacaine Treatment 2a

Placebo SABER-Bupivacaine Treatment 2b

PLACEBO COMPARATOR

double-blind

Drug: Placebo SABER-Bupivacaine Treatment 2b

Bupivacaine HCl Treatment 2c

ACTIVE COMPARATOR

double-blind

Drug: Bupivacaine HCl Treatment 2c

Interventions

SABER-Bupivacaine Treatment 1a DRUG

5.0 ml

SABER-Bupivacaine Treatment 1a

Placebo SABER-Bupivacaine Treatment 1b DRUG

5.0 ml

Also known as: POSIMIR® bupivacaine solution

Placebo SABER-Bupivacaine Treatment 1b

Bupivacaine HCl Treatment 1c DRUG

40 ml

Bupivacaine HCl Treatment 1c

SABER-Bupivacaine Treatment 2a DRUG

7.5 ml

SABER-Bupivacaine Treatment 2a

Placebo SABER-Bupivacaine Treatment 2b DRUG

7.5 ml

Placebo SABER-Bupivacaine Treatment 2b

Bupivacaine HCl Treatment 2c DRUG

40 ml

Bupivacaine HCl Treatment 2c

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A planned elective, abdominal hysterectomy
• Patients suitable for general anaesthesia

You may not qualify if:

• Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
• Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances. History of cured localised malignancies is allowed (i.e. basal or squamous cell skin carcinoma, breast carcinoma or cervical carcinoma)
• Abnormal ECG
• Prolonged QT syndrome
• Current or regular use of analgesic medication for other indication(s)

Sponsors & Collaborators

• Durect: lead
• Nycomed: collaborator

Study Sites (14)

Nycomed

Paris, France

Location

Nycomed

Bayreuth, Germany

Location

Nycomed

Dresden, Germany

Location

Nycomed

Békéscsaba, Hungary

Location

Nycomed

Budapest, Hungary

Location

Nycomed

Debrecen, Hungary

Location

Nycomed

Győr, Hungary

Location

Nycomed

Nyíregyháza, Hungary

Location

Nycomed

Székesfehérvár, Hungary

Location

Nycomed

Szolnok, Hungary

Location

Nycomed

Tatabánya, Hungary

Location

Nycomed

Riga, Latvia

Location

Nycomed

Stockholm, Sweden

Location

Nycomed

London, United Kingdom

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Deborah Scott
• Organization: Durect Corporation

deborah.scott@durect.com

408-777-1417

Study Officials

• Nycomed Clinical Trial Operations

  Headquarters

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2009
• First Posted: October 12, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: June 1, 2021
• Results First Posted: June 1, 2021

Record last verified: 2021-05

Locations

HU (8); DE (2); SE (1); FR (1); LA (1); GB (1)