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DSIP

Emideltide, DSIP nonapeptide, Delta sleep-inducing peptide

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Studies 458
Trials 82
Completed NA INTERVENTIONAL NCT02394951

Pregabalin in CIPN

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The investigators seek to investigate certain patient characteristics that would predict the response to a currently approved analgesic, pregabalin, in patients with chronic pain due to nerve damage caused by chemotherapy. Patients with this painful condition, called chemotherapy-induced peripheral neuropathy (CIPN) have a current or recent history of chemotherapy with particular chemotherapy agents called taxanes or oxaliplatin. The investigators will recruit potential subjects from both the Siteman Cancer Center and the Washington University Pain Management Center. Those patients who meet the inclusion and satisfy the exclusion criteria will be enrolled. Subjects will undergo mechanical and thermal sensitivity testing on their extremities, will provide quality of life information by completing questionnaires and will receive pregabalin followed by placebo, or placebo followed by pregabalin \[crossover design\] in order to assess how well the sensory tests predict the analgesic effect of pregabalin (compared to placebo).

Interventions

Name: Pregabalin
Type: DRUG
Description: Anticonvulsant
Name: Placebo
Type: DRUG
Description: Identical, matching inactive substance

Primary Outcomes

Measure: Change in Spontaneous Pain Intensity as a Function of Baseline MPT
TimeFrame: Baseline to week 4
Description: Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment. The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared.

Trial Information

NCT ID

NCT02394951

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Washington University School of Medicine

Last Updated

December 15, 2025