Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01968018
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.
Detailed Description:
This is an open-label (all people know the identity of the intervention) study. A total of 35 participants will be enrolled in this study. Participants will receive tablet of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) on Day 1. Participants may increase their daily dosage of study medication as 1 to 2 tablets every 4 to 6 hours as needed for pain relief, up to maximum of 8 tablets per day. Rescue medication consisting of Extra Strength Tylenol (500 mg) 2 tablets daily for the first six days of the Open-label Phase will be allowed so that the total daily dose of acetaminophen will not exceed 4,000 mg. The total duration of the study treatment for each participant will be approximately 6 weeks. Safety will be evaluated by assessment of adverse events, clinical laboratory tests, skin site assessments, vital signs, and physical examination which will be monitored throughout the study.
Study:
NCT01968018
Study Brief:
Protocol Section:
NCT01968018