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:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT00160667
Eligibility Criteria:
Inclusion Criteria:
Inclusion Criteria:
* Male/female subject aged 18 years or older.
* Pain present for at least 6 months after healing of the acute herpes zoster skin rash.
* Pain intensity score assessed on an 11-point numerical pain rating scale with a score of at least 4 at the screening visit and with an average weekly score of at least 4 on an 11-point numerical pain rating scale during baseline period.
Exclusion Criteria:
* Subject getting any kind of psychological support to help cope with pain such as biofeedback or behavioral cognitive therapy.
* Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy for post-herpetic neuralgia (PHN) or who receives trans-electrical neural stimulation (TENS.
* Tricyclic antidepressants (TCAs) or non-steroidal anti-inflammatory drug (NSAIDs) or permitted opioid analgesics ('strong' opioids are forbidden) that started less than 30 days and/or are not stabilized prior to screening and/or are not expected to be kept stable during the study.
* Intake of more than two pain treatments at trial entry (screening visit) including Tricyclic antidepressants (TCAs), non-steroidal anti-inflammatory drugs (NSAIDs) or permitted opioid analgesics.
* Subject being treated with Carbamazepine for any indication.
* Known coexistent source of painful peripheral neuropathy or other systemic disease associated with a secondary painful neuropathy.
* Subject being treated in the four weeks prior to screening visit with 'strong' opioid analgesics.
Exclusion Criteria:
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00160667
Study Brief:
Protocol Section:
NCT00160667