A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy

NCT ID: NCT00609466

Last Updated: 2011-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 291 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-02-29

Brief Summary

The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy.

This trial was performed based on a previously performed double-blind, placebo-controlled, multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75 and 100 mg) published under PMID: 18851776.

Detailed Description

Subjects undergoing bunionectomy often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when subjects receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. CG5503, a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this trial is to investigate the effectiveness (level of pain control) and safety (side effects) of CG5503 IR 75mg compared with no drug (placebo) or one dose of morphine (an opioid commonly used to treat post-surgical pain). This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter trial to evaluate the treatment of acute pain after bunionectomy. The trial will include a blinded 72 hour inpatient phase immediately following bunionectomy, during which subjects will be treated with either 75-mg CG5503 IR, a placebo, or 30-mg morphine, and pain relief will be periodically assessed. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR), and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and morphine. The alternative trial hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 48 hours.

Conditions

Bunionectomy; Pain; Postoperative Pain; Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

CG5503 IR 75mg 4 to 6 hourly for 72 hours

Group Type: EXPERIMENTAL

CG5503 IR

Intervention Type: DRUG

75mg IR 4 - 6 hourly Total: 72 hours

2

Morphine IR 30 mg 4 to 6 hourly for 72 hours

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

Morphine 30 mg IR 4 - 6 hourly Total: 72 hours

3

Matching placebo 4 to 6 hourly for 72 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo; 4 - 6 hourly; Total: 72 hours

Interventions

CG5503 IR

75mg IR 4 - 6 hourly Total: 72 hours

Intervention Type: DRUG

Morphine

Morphine 30 mg IR 4 - 6 hourly Total: 72 hours

Intervention Type: DRUG

Placebo

Placebo; 4 - 6 hourly; Total: 72 hours

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female subjects between 18 and 80 years of age;
• Scheduled to undergo primary unilateral first metatarsal bunionectomy;
• Anesthesiological and surgical procedures performed according to protocol;
• Moderate or severe baseline pain following bunionectomy on a VRS within 9 hours of termination of the continuous popliteal sciatic block or systemic analgesia;
• Pain following bunionectomy of at least 4 on an 11-point NRS within 9 hours of termination of the continuous popliteal sciatic block or systemic analgesia; American Society of Anesthesiologists (ASA) classification I-III.

Exclusion Criteria

• History of seizure disorder;
• History of alcohol, medication or drug dependency, unstable psychological personality requiring intermittent or permanent treatment; severely impaired renal function, moderately or severely impaired hepatic function;
• Contraindications to, or history of allergy or hypersensitivity to CG5503, oxycodone, morphine, fentanyl hydrocodone, acetaminophen, heparin, or any compound planned to be used during the anesthesia, or their excipients;
• Pre-operative use within 12h prior to surgery or peri-operative use of non- steroidal anti-inflammatory drugs (NSAIDs);
• Treated regularly with opioid analgesic or NSAIDs within 30 days prior to screening;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: collaborator

Grünenthal GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen E Daniels, DO

Role: PRINCIPAL_INVESTIGATOR

Premier Research Group (formerly SCIREX Corporation)

Locations

Site 104

Pasadena, Maryland, United States

Site 101

Austin, Texas, United States

Site 102

Houston, Texas, United States

Site 105

San Antonio, Texas, United States

Site 103

San Marcos, Texas, United States

Site 106

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

574139

Identifier Type: -

Identifier Source: org_study_id