Clinical Study for Assessment of the Efficacy of Gabapentin (Carbatin and Neurontin) in Patients With Neuropathy Pain

NCT02074267 | Completed Phase 4

• 1 other identifier: S08174
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy of Gabapentin (Carbatin \& Neurontin) in patients with neuropathy pain.

Conditions

Neuropathy; Pain

Outcome Measures

Primary Outcomes (1)

• Evaluation of pain intensity using the visual analog scale (VAS)

  up to six weeks

Study Arms (2)

Carbatin

EXPERIMENTAL

Carbatin is initiated at 100 mg at night and slowly titrated to 300\~800 mg three times/day over 4 to 25 days

Drug: Carbatin

Neurontin

ACTIVE COMPARATOR

Neurontin is initiated at 100 mg at night and slowly titrated to 300\~800 mg three times/day over 4 to 25 days

Drug: Neurontin

Interventions

Carbatin DRUG

Carbatin® or Neurontin® is initiated at 100 mg at night and slowly titrated to 300\~800 mg three times/day over 4 to 25 days. The dose of Carbatin® or Neurontin® taken by each patient will amount to 100 to 2400 mg /day oral if the pain intensity reaches a VAS score ≧4. The maintenance dose of Carbatin® or Neurontin® will throughout for at least 14 days of the treatment period.

Carbatin

Neurontin DRUG

Carbatin® or Neurontin® is initiated at 100 mg at night and slowly titrated to 300\~800 mg three times/day over 4 to 25 days. The dose of Carbatin® or Neurontin® taken by each patient will amount to 100 to 2400 mg /day oral if the pain intensity reaches a VAS score ≧4. The maintenance dose of Carbatin® or Neurontin® will throughout for at least 14 days of the treatment period.

Neurontin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be 20 years of age or older.

You may not qualify if:

• Subjects who are pregnant, lactating or of childbearing potential not using effective contraceptives.
• Subjects who have a clinically significant or unstable medical or psychiatric condition.
• Subjects who are known of hypersensitivity to Gabapentin.
• Serum creatinine \> 1.5 times the upper limit of normal
• Subjects who have received nerve blocks or acupuncture for pain relief within four weeks before a screening / baseline period.
• Subjects who have the presence of chronic pain other than the target pain being studied (unless the chronic pain is in a different body region than the target pain and its intensity is not greater than that of the target pain).
• Subjects who have received nondrug therapies or any special procedures for the relief of the target pain within two weeks before a baseline visit.
• Subjects who are using the following agents within 30 days prior to screening: antidepressants, opioids, other anticonvulsants, local anaesthetic injections or any investigational drug.

Sponsors & Collaborators

• Nang Kuang Pharmaceutical Co., Ltd.: lead
• Taichung Veterans General Hospital: collaborator

Study Sites (1)

Nang Kuang Pharmaceutical Co., LTD

Tainan, 712, Taiwan

Location

MeSH Terms

Conditions

Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: February 28, 2014
• Study Start: March 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 9, 2023

Record last verified: 2020-07

Locations

TW (1)