Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT01869569
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have received radiation therapy for histologically confirmed head and neck cancer.
2. Clinical evidence support the diagnosis of radiation-related neuropathic pain (confirmed by the Michigan Neuropathy Screening Instrument) and had a daily pain score of 4 or higher based on a numerical rating scale (0-10 points).
3. Neuropathic pain defined according to clinical history, symptoms, physical signs, and a score\>= 12 in Chinese version of Leeds Assessment of Neuropathic Symptoms and Signs questionnaire by two neurology specialists.
4. The mean duration of pain is more than 4 weeks.
5. Fertile women who are willing to take contraception during the trial.
6. Routine laboratory studies with bilirubin \</=2 \* upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) \< 2 \* ULN, creatinine \<1.0 \* ULN, red-cell count \>/= 4,000 per cubic millimeter; white-cell count \>/=1500 per cubic millimeter, platelets \>/= 75,000 per cubic millimeter; Hb \>/=9.0.
7. Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
1. Current diagnosis of tumor recurrence or metastasis and evidence of tumor associated pain.
2. Evidence of secondary neuropathic pain other than radiation.
3. Treatment with carbamazepine, gabapentin or pregabalin within 30 days before study enrollment.
4. Ongoing treatment for neuropathic pain.
5. History of anaphylactic response to pregabalin.
6. Evidence of sever systematic diseases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01869569
Study Brief:
Protocol Section:
NCT01869569