Recent Updates
Recently added Catalysts

CG5503 IR

Phase 3

Bunionectomy | Small molecule | Pain |Johnson & Johnson|Last Updated: Oct 28, 2019

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment291

FDA Designations

No designations recorded

Clinical trial landscape

CG5503 IR · 2 trials · 6 indications

Phase 3 2
NCT00478023A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal HysterectomyHysterectomy
COMPLETED854 Analytics
NCT00609466A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After BunionectomyBunionectomy
COMPLETED291 Analytics
PHASE3COMPLETED
A Study to Evaluate the Efficacy and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain After Abdominal Hysterectomy
Hysterectomy
NCT00478023854
Unlock trial analytics
PHASE3COMPLETED
A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
Bunionectomy
NCT00609466291
Unlock trial analytics

Study Endpoints

Primary Endpoints

Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity.
Baseline to 24 hours after first intake of study drug

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, assuming patients start with a baseline value of 10 and all subsequent values will be 0).

Secondary Endpoints

Sum of Pain Intensity Differences Relative to the Baseline Pain Intensity
Baseline value to 48 hours after first study drug intake.
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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MorphineACTIVE_COMPARATOR -
Tapentadol 50 mg immediate releaseEXPERIMENTAL -
Tapentadol 75 mg immediate releaseEXPERIMENTAL -
Tapentadol 100 mg immediate releaseEXPERIMENTAL -
Matched placeboPLACEBO_COMPARATOR -
1EXPERIMENTALCG5503 IR 75mg 4 to 6 hourly for 72 hours
2ACTIVE_COMPARATORMorphine IR 30 mg 4 to 6 hourly for 72 hours
3PLACEBO_COMPARATORMatching placebo 4 to 6 hourly for 72 hours

Interventions

NameTypeDescription
MorphineDRUG20 mg IR; 4 - 6 hourly; Total 72 hours
CG5503 IRDRUG50mg; 4 - 6 hourly; Total 72 hours
PlaceboDRUG4 - 6 hourly; Total 72 hours
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 80 Years
SexFEMALE
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: * Female between 18 and 80 years of age; * Scheduled to undergo an abdominal hysterectomy with or without bilateral salpingo-oophorectomy due to uterine leiomyomas, or dysfunctional uterine bleeding or endometrial hyperplasia; * Anesthesiological and surgical procedures performe...

Countries:HungaryLatviaPolandRomaniaRussiaSerbiaSlovakiaSloveniaUkraineUnited States
Unlock Eligibility Criteria

Frequently asked questions about CG5503 IR

What is CG5503 IR used for?

CG5503 IR is an investigational small molecule being studied for the treatment of acute pain following bunionectomy and abdominal hysterectomy. It is in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its efficacy and safety in managing postoperative pain.

What does CG5503 IR target?

CG5503 IR is a small molecule being developed for pain management. Its specific molecular target has not been disclosed in available information. The drug is being studied in Phase 3 clinical trials for acute pain after surgical procedures, including bunionectomy and hysterectomy.

Who makes CG5503 IR?

CG5503 IR is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 3 clinical trials for the treatment of acute pain following bunionectomy and hysterectomy.

What phase is CG5503 IR in?

CG5503 IR is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for the management of acute pain after bunionectomy and hysterectomy procedures.

What clinical trials is CG5503 IR in?

CG5503 IR has completed two Phase 3 clinical trials. NCT00478023 evaluated the drug in 854 female patients with postoperative pain after abdominal hysterectomy across multiple countries. NCT00609466 studied 291 patients with acute pain after bunionectomy in the United States. Both trials were randomized, double-blind, and placebo-controlled.

Is CG5503 IR the same as tapentadol?

CG5503 IR is also known as tapentadol. Clinical trial records refer to the drug as CG5503, and its mechanism involves pain relief. The drug is being developed by Johnson & Johnson for acute pain management following surgical procedures.