A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain

NCT01968018 | Completed Phase 4

• 2 other identifiers: CR013510TRAMAPANA4001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the analgesic (painkiller) effectiveness and safety of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) in the treatment of chronic cancer pain.

Conditions

Cancer

Keywords

Cancer; Chronic Cancer Pain; Tramadol HCI; Acetaminophen; Analgesics; Pain assessment

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Brief Pain Inventory (BPI) Pain Severity "Pain at Its Worst" (BPI Item 3) at Day 42

  Change from baseline in pain severity was assessed using the Brief Pain Inventory (BPI) questionnaire, specifically "pain at its worst" (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its worst".

  Baseline (Day 1) to Day 42

• Change from Baseline in Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score

  The analgesic effect was assessed by the Brief Pain Inventory (BPI) item 5 "pain on average" using a 0 to 10 numeric rating scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine". Higher scores indicate worsening.

  Baseline (Day 1) to Day 42

• Number of Participants With Adverse Events

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Up to Day 42

• Number of Doses of Rescue Medication Over Time

  Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study medication is not satisfactory, or the effect of the study medication is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (medication used to control pain) were used as rescue medication.

  Days 7, 14, 28, 35 and 42

Secondary Outcomes (3)

• Number of Participants With Patient Global Assessment (PGA)

  Day 42

• Number of Participants With Investigator Global Assessment

  Day 42

• Change From Baseline in Quality of Life (QOL) by Using Functional Assessment of Cancer Therapy General Scale (FACT-G) Total Score at Day 42

  Baseline (Day 1) and Day 42

Study Arms (1)

Tramadol HCI + acetaminophen

EXPERIMENTAL

Drug: Tramadol HCI/acetaminophen

Interventions

Tramadol HCI/acetaminophen DRUG

Participants will receive tablet of tramadol HCI (37.5 mg)/acetaminophen (325 mg) on Day 1. Participants may increase their daily dosage of study medication is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to maximum of 8 tablets per day.

Also known as: Ultracet

Tramadol HCI + acetaminophen

Eligibility Criteria

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

You may qualify if:

• Participants whose pain has reached a stage now requiring treatment with a weak opioid, according to the opinion of treating physician
• Participants who have received a regular weak opioid, for at least 48 hours and at a dosage appropriate for their pain at that time
• Participants with a histologically, radiologically or hematologically confirmed malignancy; whose pain is judged by the investigator to be caused by the malignancy

You may not qualify if:

• Participants who have already received regular treatment with a strong opioid for their cancer pain. This should not exceed more than 3 doses of a strong immediate release opiod in last 7 days, and none in last 24 hours
• Participants with significant abnormalities in hepatic or renal function which would in the opinion of the investigator, prevent the participants involvement in the study
• Participants with a history of allergy or hypersensitivity to tramadol or acetaminophen
• Participants who, at entry have treatments planned which may alter abruptly, the degree or nature of pain experienced (eg radiotherapy, neurological techniques surgery)
• Participants with a history of abuse of opioid analgesics prior to their diagnosis of cancer

Sponsors & Collaborators

• Janssen-Cilag Ltd.,Thailand: lead

Study Sites (1)

Unknown Facility

Bangkok, Thailand

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Ultracet

Study Officials

• Janssen-Cilag Ltd.,Thailand Clinical Trial

  Janssen-Cilag Ltd.,Thailand

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: July 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: October 23, 2013

Record last verified: 2013-10

Locations

TH (1)