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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04662281
Other study ID # LX9211.1-202-PHN
Secondary ID 2020-004639-26
Status Completed
Phase Phase 2
First received
Last updated
Start date December 29, 2020
Est. completion date December 21, 2022

Study information

Verified date November 2023
Source Lexicon Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of the efficacy of LX9211 compared to placebo in reducing pain related to postherpetic neuralgia over an 11 week assessment period.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date December 21, 2022
Est. primary completion date November 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participant has given written informed consent to participate in the study in accordance with local regulations - Adult male and female participants =18 years of age at the time of screening - PHN pain that is present for =3 months after healing of herpes zoster skin rash affecting a single dermatome (Participants with more than 1 involved dermatome may also be included, provided the affected dermatomes are contiguous) - Moderate to severe pain as confirmed by average pain score using scores recorded in the pain diary in the 14 days prior to randomization Exclusion Criteria: - Presence of other painful conditions that may confound assessment or self-evaluation of PHN - History of major depressive episode, active, significant psychiatric disorders - History of clinically significant drug or alcohol use disorder - PHN affecting the face - Use of opioid medications for management of PHN within the 2 months prior to Screening Visit - Use of Non-steroidal anti-inflammatory drugs (NSAIDs) for the specific treatment of PHN pain

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
LX9211 matching-placebo, tablets will be administered orally.
LX9211
LX9211, 200 mg, tablets will be administered orally.

Locations

Country Name City State
Czechia Lexicon Investigational Site (138) Chocen
Czechia Lexicon Investigational Site (140) Pardubice
Czechia Lexicon Investigational Site (135) Praha
Czechia Lexicon Investigational Site (136) Praha
Czechia Lexicon Investigational Site (137) Praha
Czechia Lexicon Investigational Site (141) Praha
Poland Lexicon Investigational Site (128) Katowice
Poland Lexicon Investigational Site (130) Katowice
Poland Lexicon Investigational Site (134) Lublin
Poland Lexicon Investigational Site (133) Warsaw
United States Lexicon Investigational Site Albuquerque New Mexico
United States Lexicon Investigational Site Baytown Texas
United States Lexicon Investigational Site Boston Massachusetts
United States Lexicon Investigational Site Brandon Florida
United States Lexicon Investigational Site Canton Michigan
United States Lexicon Investigational Site (148) Cary North Carolina
United States Lexicon Investigational Site Flossmoor Illinois
United States Lexicon Investigational Site Greenbrae California
United States Lexicon Investigational Site Hazelwood Missouri
United States Lexicon Investigational Site Jenkintown Pennsylvania
United States Lexicon Investigational Site Kenosha Wisconsin
United States Lexicon Investigational Site (147) Marietta Georgia
United States Lexicon Investigational Site Miami Florida
United States Lexicon Investigational Site Miami Florida
United States Lexicon Investigational Site (113) Miami Florida
United States Lexicon Investigational Site Ormond Beach Florida
United States Lexicon Investigational Site Salt Lake City Utah
United States Lexicon Investigational Site Scottsdale Arizona
United States Lexicon Investigational Site Tucson Arizona
United States Lexicon Investigational Site Victoria Texas
United States Lexicon Investigational Site Wauconda Illinois
United States Lexicon Investigational Site Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Lexicon Pharmaceuticals

Countries where clinical trial is conducted

United States,  Czechia,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Average Daily Pain Score (ADPS) The change from Baseline (Week 2) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (0 [No Pain] to 10 [Pain as bad as you can imagine]) Day 1 to Week 6
Secondary =30 percent reduction in pain intensity Proportion of patients with =30% reduction in pain intensity Day 1 to Week 6
Secondary =50 percent reduction in pain intensity Proportion of patients with =50% reduction in pain intensity Day 1 to Week 6
Secondary Safety: number of AEs reported Number of Adverse Events Day 1 to Week 6
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