Clinical trial NCT00609466: A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
Official title: A Randomized, Double-blind, Parallel-group, Multi-center, Active- and Placebo-controlled Trial to Evaluate the Analgesic Efficacy and Safety of Multiple Doses of CG5503 IR for Postoperative Pain Following Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bunionectomy
Pain
Postoperative Pain
Acute Pain
Keywords: Opioid
Central acting analgesic
CG5503 IR
Postoperative pain
Bunionectomy
Morphine
Placebo
Lead sponsor: Grünenthal GmbH
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First posted: 2008-02-07
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.
timeFrame: Baseline value to 48 hours after first study drug intake.
Secondary outcomes:
measure: Number of Participants Using Rescue Medication
timeFrame: Baseline up to 72 hours after first study drug intake
measure: Total Pain Relief (TOTPAR)
timeFrame: Baseline to 48 hours after first study drug intake
measure: Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity
timeFrame: Baseline to 6 hours after intake of first study drug
measure: Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity
timeFrame: Baseline to 12 hours after first study drug intake
measure: Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity
timeFrame: Baseline to 24 hours after first study drug intake
measure: Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity
timeFrame: Baseline to 72 hours after first intake of study drug
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Site 104
state: Maryland
city: Austin
country: United States
facility: Site 101
state: Texas
city: Houston
country: United States
facility: Site 102
state: Texas
city: San Antonio
country: United States
facility: Site 105
state: Texas
city: San Marcos
country: United States
facility: Site 103
state: Texas
city: Salt Lake City
country: United States
facility: Site 106
state: Utah
Study officials:
affiliation: Premier Research Group (formerly SCIREX Corporation)
name: Stephen E Daniels, DO
role: PRINCIPAL_INVESTIGATOR
References: