A Study Comparing the Effectiveness and Safety of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen With Immediate Release (IR) Tramadol HCl/Acetaminophen in Participants With Moderate to Severe Postoperative Pain

NCT01814878 | Completed Phase 3 Results

• 2 other identifiers: CR016636TRAMAPPAI3005
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen with immediate release (IR) tramadol HCl/acetaminophen in participants with moderate to severe (very serious, life threatening) postoperative pain.

Conditions

Pain, Postoperative

Keywords

Pain, Postoperative; Tramadol Hydrochloride; Acetaminophen; Ultracet

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference (SPID) at Hour 48

  The SPID is time-weighted sum of all observations of pain intensity difference (PID) collected at each measurement time point from Baseline to 48 hours. PID: Baseline pain intensity (PI) minus current PI; PI was assessed using 11-point numeric rating scale (NRS, 0=no pain to 10=worst pain imaginable). PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score \>=1 and \<=3, PI score of 2=NRS score of \>=4 and \<=6 and PI score of 3=NRS score of \>=7 and \<=10. Total score for SPID at 48 hours (SPID48) ranges from -144 (worst) to 144 (best).

  Hour 48

Secondary Outcomes (7)

• Sum of Pain Intensity Difference (SPID) at Hour 6, 12 and 24

  Hour 6, 12, 24

• Total Pain Relief (TOTPAR) Score

  Hour 6, 12, 24, 48

• Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID)

  Hour 6, 12, 24, 48

• Time to the First Rescue Medication Administered Because of Insufficient Pain Relief

  Baseline up to Day 3

• Number of Doses of Rescue Medication Administered Because of Insufficient Pain Relief

  Baseline up to Day 3

Study Arms (2)

Tramadol Hydrochloride/Acetaminophen ER

EXPERIMENTAL

Participants will be administered 2 oral tablets of extended release (ER) tramadol HCl (75 milligram \[mg\])/acetaminophen (650 mg) and 2 tablets of placebo matching to immediate release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matching to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.

Drug: Tramadol HCl/Acetaminophen ER

Tramadol HCl/Acetaminophen IR

ACTIVE COMPARATOR

Participants will be administered 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matching to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.

Drug: Tramadol HCl/Acetaminophen IR

Interventions

Tramadol HCl/Acetaminophen ER DRUG

2 tablets of ER (tramadol HCl \[75 mg\]/acetaminophen \[650 mg\]) will be administered at 0, 12, 24 and 36 hours

Also known as: Ultracet

Tramadol Hydrochloride/Acetaminophen ER

Tramadol HCl/Acetaminophen IR DRUG

2 tablets of IR (tramadol HCl \[37.5 mg\]/acetaminophen \[325 mg\]) at 0, 6, 12, 18, 24, 30, 36 and 42 hours

Also known as: Ultracet

Tramadol HCl/Acetaminophen IR

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are scheduled to have standard primary (non-revision) unilateral (having to do with only 1 side of a structure) total knee replacement arthroplasty (TKRA-surgery to fix a joint) for non-inflammatory (no swelling, redness, and pain in tissues caused by injury or damage) degenerative joint disease (NIDJD)
• Participants who are capable of oral (having to do with the mouth) intake
• Women must be: postmenopausal (for at least 1 year), surgically sterile, abstinent (not having sexual intercourse), or practicing a highly effective method of birth control before participation in the study and who agree to continue to use the same method of birth control throughout the study in cases of women of childbearing potential
• Male participants must practice contraception, and must agree not to donate his sperms for 1 month after the last dose of study drug
• Participants who will complain of baseline pain of intensity of greater than or equal to 4 on 11-point numeric rating scale (NRS) measured within 1 hour prior to randomization (study drug assigned by chance) and a maximum of 6 hours after discontinuation of participant controlled analgesia (PCA) after at least 12 hours of application following TKRA

You may not qualify if:

• Participants with Illness history (severe \[very serious, life threatening\] hepatic \[having to do with the liver\] failure, severe renal \[having to do with the kidney\] failure; severe respiratory depression; risk for mental fog with head injury or brain lesions \[abnormal area of tissue, such as a wound, sore, rash, or boil\]; digestive ulcer \[sore\], severe blood abnormalities; severe cardiac insufficiency; aspirin asthma \[asthmatic attack-breathing disorder in which there is a wheezing and difficulty in breathing; caused by non-steroidal anti-inflammatory drugs\] or history of aspirin asthma; history of epilepsy \[seizure disorder\]; rheumatism, significant psychiatric disorder or taking antipsychotic drugs for psychiatric treatment)
• Administration of disallowed therapy such as: administration of oral, patch, injection or local analgesics (drug used to control pain) acting centrally (the brain and the spinal cord) or peripherally (not central) before study drug administration after completion of PCA application, surgery is conducted simultaneously in addition to TKRA, administration of monoamine oxidase (MAO) inhibitors or discontinuation of the administration within 2 weeks, tricyclic antidepressants that may increase the seizure (sudden, uncontrolled muscle spasms and loss of consciousness resulting from abnormal brain function) risk when concomitantly (given at the same time) administered, neuroleptics, or drugs that may lower the seizure threshold, use of sedatives (a medication to calm or make less anxious) other than that used for general anesthesia (loss of sensation or feeling) during surgery
• Participants who used any study drug or investigational medical device within 30 days before the start of the treatment
• Participants requiring postoperative intensive care unit (ICU) care
• Participants having hypersensitivity to tramadol or acetaminophen

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Related Publications (1)

• Park YB, Ha CW, Cho SD, Lee MC, Lee JH, Seo SS, Kang SB, Kyung HS, Choi CH, Chang N, Rhim HY, Bin SI. A randomized study to compare the efficacy and safety of extended-release and immediate-release tramadol HCl/acetaminophen in patients with acute pain following total knee replacement. Curr Med Res Opin. 2015 Jan;31(1):75-84. doi: 10.1185/03007995.2014.975338. Epub 2014 Oct 31.

  PMID: 25299350 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ultracet

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Research Director
• Organization: Janssen Korea/25F, LS Yongsan Tower, 191 Hankangro 2-Ga, Yongsan-Gu, Seoul 140-702, Korea

82-2-2094-4518

Study Officials

• Janssen Korea Ltd. Clinical Trial

  Janssen Korea Ltd.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: November 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 20, 2013
• Results First Posted: June 20, 2013

Record last verified: 2013-06