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

Durect

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Bupivacaine HCl Treatment 1c; Drug: SABER-Bupivacaine Treatment 1a; Drug: SABER-Bupivacaine Treatment 2a; Drug: Placebo SABER-Bupivacaine Treatment 1b; Drug: Placebo SABER-Bupivacaine Treatment 2b; Drug: Bupivacaine HCl Treatment 2c

Study type: Interventional

Funder types: Industry

Identifiers

NCT00993226

BU-001-IM

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 6 patient groups, including a placebo group

SABER-Bupivacaine Treatment 1a

Experimental group

Description:

double-blind

Treatment:

Drug: SABER-Bupivacaine Treatment 1a

Placebo SABER-Bupivacaine Treatment 1b

Placebo Comparator group

Description:

double-blind

Treatment:

Drug: Placebo SABER-Bupivacaine Treatment 1b

Bupivacaine HCl Treatment 1c

Active Comparator group

Description:

double-blind

Treatment:

Drug: Bupivacaine HCl Treatment 1c

SABER-Bupivacaine Treatment 2a

Experimental group

Description:

double-blind

Treatment:

Drug: SABER-Bupivacaine Treatment 2a

Placebo SABER-Bupivacaine Treatment 2b

Placebo Comparator group

Description:

double-blind

Treatment:

Drug: Placebo SABER-Bupivacaine Treatment 2b

Bupivacaine HCl Treatment 2c

Active Comparator group

Description:

double-blind

Treatment:

Drug: Bupivacaine HCl Treatment 2c