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

NCT00609466 | Completed Phase 3 Results

• 1 other identifier: 574139
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 6

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.

Conditions

Bunionectomy; Pain; Postoperative Pain; Acute Pain

Keywords

Opioid; Central acting analgesic; CG5503 IR; Postoperative pain; Bunionectomy; Morphine; Placebo

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.

  Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \[baseline-post baseline\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain).

  Baseline value to 48 hours after first study drug intake.

Secondary Outcomes (6)

• Number of Participants Using Rescue Medication

  Baseline up to 72 hours after first study drug intake

• Total Pain Relief (TOTPAR)

  Baseline to 48 hours after first study drug intake

• Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity

  Baseline to 6 hours after intake of first study drug

• Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity

  Baseline to 12 hours after first study drug intake

• Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity

  Baseline to 24 hours after first study drug intake

Study Arms (3)

1

EXPERIMENTAL

CG5503 IR 75mg 4 to 6 hourly for 72 hours

Drug: CG5503 IR

2

ACTIVE COMPARATOR

Morphine IR 30 mg 4 to 6 hourly for 72 hours

Drug: Morphine

3

PLACEBO COMPARATOR

Matching placebo 4 to 6 hourly for 72 hours

Drug: Placebo

Interventions

CG5503 IR DRUG

75mg IR 4 - 6 hourly Total: 72 hours

1

Morphine DRUG

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

2

Placebo DRUG

Placebo; 4 - 6 hourly; Total: 72 hours

3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Grünenthal GmbH: lead
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

Study Sites (6)

Site 104

Pasadena, Maryland, 21122, United States

Location

Site 101

Austin, Texas, 78705, United States

Location

Site 102

Houston, Texas, 77081, United States

Location

Site 105

San Antonio, Texas, 78229, United States

Location

Site 103

San Marcos, Texas, 78666, United States

Location

Site 106

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative; Acute Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Lortab (hydrocodone/acetaminophen) was allowed as rescue medication.

Results Point of Contact

• Title: René Allard
• Organization: Grunenthal

Clinical-Trials@grunenthal.com

49 241 569 3223

Study Officials

• Stephen E Daniels, DO

  Premier Research Group (formerly SCIREX Corporation)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 7, 2008
• Study Start: September 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: November 16, 2011
• Results First Posted: November 25, 2009

Record last verified: 2011-11

Locations

US (6)