Pregabalin Treatment Of Peripheral Neuropathic Pain Associated With Diabetic Peripheral NeP (DPN), Postherpetic Neuralgia (PHN), HIV-related NeP (HIV), and Chemotherapy Induced NeP

Not Applicable

• Conditions: -G632 Diabetic polyneuropathy (E10-E14+ with common fourth character.4)-G630 Polyneuropathy in infectious and parasitic diseases classified elsewhere-G620 Drug-induced polyneuropathy; Drug-induced polyneuropathy; Polyneuropathy in infectious and parasitic diseases classified elsewhere; Diabetic polyneuropathy (E10-E14+ with common fourth character.4); G620; G630; G632

• Registration Number: PER-089-06
• Lead Sponsor: PFIZER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-07
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients who are diagnosed of neuropathic pain associated with DPN, PHN, HIV-PNP or C-PNP.
2. Male or female patients of any ethnic origin aged 18 years or over.
3. Outpatients status.
4. Women of childbearing potential must have a negativo urine B-HCG pregnancy test and be practicing an effective form of contraception.
5. Patients taking pharmacological therapies for neurophatic pain must be stabilized > 30 days prior to screening, and be willing to held them constant and avoid change or initiation of new therapies throughout the course of the trial.
6. Patients undergoing stable non-pharmacological therapies for neuropathic pain, if used in normal routine > 30 days prior to screening, must be willing to held them constant and avoid change or initiation of new therapies throughout the course of the trial.
7. Evidence of a personally signed informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
8. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
9. Score of ≥ 40 mm on the 100-mm Visual Analogue Scale (VAS) at screening.
10. Must have completed at least 4 consecutive daily pain diaries (DPRS) during the 7 days prior to trial drug treatment.
11. Daily diary average pain score of ≥ 4 over the 7 days prior to trial drug treatment based on Daily Pain Rating Scale (DPRS).
12. Score of ≥ 4/10 on the neuropathic pain diagnostic questionnaire (DN4)
Inclusion criteria applied to patients with PHN:
13. Pain present for > 3 months after healing of herpes zoster skin rash.
14. Screening laboratory values must be within normal limits, or abnormalities must be clinically insignificant.
Inclusion criteria applied to patients with HIV-PNP:
15. Patients with confirmed diagnosis of HIV infection.
16. HIV-associated neuropathic pain present for at least 3 months prior to trial start.
17. Patients on stable HIV and pain medications.
Inclusion criteria applied to patients with C-PNP:
18. Chemotherapy induced neuropathic pain present for at least 3 months prior to trial start.
19. Patients must have had their last dose of radiation therapy at least 4 weeks prior to trial entry.
20. Patients must have their last dose of chemotherapy and/or their last dose of any investigational cancer therapy at least 4 weeks prior to trial entry.
21. Patients must have recovered from the toxic effects of all prior therapy before entry onto this trial.
22. Patients with brain tumors must be on a stable or tapering dose of corticosteroids for 7 days prior to the baseline sean performed for the purpose of assessing response to therapy on this trial.

Exclusion Criteria

1. Severe pain associated with conditions other than DPN, PHN, HIV-PNP and C-PNP that may confound assessment or self-evaluation of the neuropathic pain.
2. Skin conditions in the affected dermatome that could alter sensation.
3. Primary pain diagnosis of acute lumbosacral radiculopathy / sciatica, chronic low back pain or cervical radiculopathy.
4. Clinically significant or unstable medical condition.
5. Clinically significant or unstable psychological condition.
6. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the trial and/or evidence of an uncooperative attitude.
7. Any moderate to severe autonomic dysfunction.
8. Clinically significant abnormal 12-lead ECG.
9. Creatinine clearence ≤ 60 mL/min.
10. White Blood Cells < 2500/mm3; neutrophil count <1500/mm3; platelet count <100 x l0-9/mm3.
11. Liver function tests > 3 times the upper limit of normal.
12. A history of illicit drug or alcohol abuse in the past 1 year.
13. Current use of illicit drugs.
14. Likelihood of requiring treatment during the trial period with drugs not permitted by the protocol.
15. Receiving concomitant transcutaneous electrical nerve stimulation or acupuncture.
16. A previous history of intolerance or hypersensitivity to the pregabalin, gabapentin or drugs with similar chemical structure.
17. Donation of blood/blood products during the 30 days prior to initiation of treatment.
18. Participation in a previous pregabalin clinical trial.
19. Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the trial.
20. The patient may require hospitalization for any reason.
21. Illiterate or unable to answer patient administered assessment scales.
22. Any other condition, which increases the risk to the patient or decreasesthe chance of obtaining satisfactory data to achieve the objectives of the trial.
23. Neurologic disorders unrelated to the primary diagnosis that may confuse the assessment of neuropathic pain.
24. History of pernicious anemia, untreated hypothyroidism, active and chronic hepatitis B or C, hepatitis B or C within the past 3 months.
25. Other significant infectious condition diagnosed within the past 3 months.
26. Amputations other than toes resulting from a primary clinical condition being investigated.
Exclusion criteria applied to DPN patients:
27. Neurological disorders unrelated to diabetic neuropathy.
28. Presence of severe pain associated with conditions other than diabetic peripheral neuropathy.
Exclusion criteria applied to PHN patients:
29. History of neurolytic or neurosurgical therapy for PHN.
30. Presence of any severe pain associated with conditions other than PHN.
31. Known coexistent source of painful peripheral neuropathy or other systemic disease associated with a secondary painful neuropathy.
Exclusion criteria applied to HIV-PNP patients:
32. Patients on anti-diabetic medications.
33. Use of neuroregenerative agents or neurotoxic chemotherapeutic agents by 3 months prior to trial start.
34. Use of neurotoxic drugs within 1 month prior to trial start.
35. Pulmonary disease of sufficient severity to require the use of supplemental oxygen.
36. Life expectancy less than 6 weeks or an active, acute illness likely to interfere with completion o

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Daily Pain Rating Scale (DPRS): The measurement will be made using a scale of 11 Likert points (0, no pain and 10, worst pain possible).<br>Measure:Change in the mean of the weekly pain index from baseline to week 12.<br>Timepoints:Week 12.<br>