Pain Clinical Trial
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
Verified date | November 2011 |
Source | Grünenthal GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 291 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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; |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Site 101 | Austin | Texas |
United States | Site 102 | Houston | Texas |
United States | Site 104 | Pasadena | Maryland |
United States | Site 106 | Salt Lake City | Utah |
United States | Site 105 | San Antonio | Texas |
United States | Site 103 | San Marcos | Texas |
Lead Sponsor | Collaborator |
---|---|
Grünenthal GmbH | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Secondary | Number of Participants Using Rescue Medication | Number of participants who used at least one dose of rescue medication during the 72 hour double blind period. | Baseline up to 72 hours after first study drug intake | No |
Secondary | Total Pain Relief (TOTPAR) | Total pain relief (TOTPAR) in the 48 hour period from the first dose of study drug. The subject was to indicate pain relief at rest in response to the following question: How much relief have you had from your starting pain? None = 0, A little = 1, Some = 2, A lot = 3 and Complete = 4. The theoretical maximum range of Total pain relief (TOTPAR)48 is from 0 (indicative of no pain relief) to 192. The higher the value the better the pain relief. | Baseline to 48 hours after first study drug intake | No |
Secondary | Sum of Pain Intensity Differences Over 6 Hours (SPID6) Relative to the Baseline Pain Intensity | Pain Intensity assessed at predefined time points over a 6 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 (SPID6) is from -60 (indicative of an increase in pain) to 60 (indicative of a decrease in pain). | Baseline to 6 hours after intake of first study drug | No |
Secondary | Sum of Pain Intensity Differences Over 12 Hours (SPID12) Relative to the Baseline Pain Intensity | Pain Intensity assessed at predefined time points over a 12 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 (SPID12) is from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). | Baseline to 12 hours after first study drug intake | No |
Secondary | Sum of Pain Intensity Differences Over 24 Hours (SPID24) Relative to the Baseline Pain Intensity | Pain Intensity assessed at predefined time points over a 24 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 (SPID24) is from -240 (indicative of an increase in pain) to 240 (indicative of a decrease in pain). | Baseline to 24 hours after first study drug intake | No |
Secondary | Sum of Pain Intensity Differences Over 72 Hours (SPID72) Relative to the Baseline Pain Intensity | Pain Intensity assessed at predefined time points over a 72 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 (SPID72) is from -720 (indicative of an increase in pain) to 720 (indicative of a decrease in pain). | Baseline to 72 hours after first intake of study drug | No |
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