Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| LX9211.204-DPN | Other Identifier | Lexicon Pharmaceuticals, Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LX9211 Low Dose | Experimental | LX9211 low dose, orally, once daily during a blinded treatment period. |
|
| LX9211 High Dose | Experimental | LX9211 high dose, orally, once daily during a blinded treatment period. |
|
| LX9211 High Dose Followed by Low Dose | Experimental | LX9211 high dose followed by LX9211 low dose, orally, once daily during a blinded treatment period. |
|
| LX9211 Placebo | Placebo Comparator | LX9211 matching placebo, orally, once daily during a blinded treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (blinded) | Drug | LX9211 matching placebo tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Week 8 in Average Daily Pain Score (ADPS) | ADPS is based on the 11-point numerical rating scale (NRS) [0 (no pain) to 10 (worst imaginable pain)]. | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline to Week 8 in Burning Pain | Burning pain is based on the 11-point NRS (0 [no burning] to 10 [worst burning imaginable]). | Baseline, Week 8 |
| Change from Baseline to Week 8 in Pain Interference on Sleep |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site (128) | Anniston | Alabama | 36207 | United States | ||
| Lexicon Investigational Site (222) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LX9211 (blinded) |
| Drug |
LX9211 (blinded) tablets |
|
Pain interference on sleep is based on the 11-point NRS (0 [does not interfere] to 10 [completely interferes]).
| Baseline, Week 8 |
| Patient Global Impression of Change (PGIC) Score at Week 8 | The PGIC is a 7-point rating scale that assesses a participant's belief about the overall improvement experienced by the participant where 1=very much improved and 7=very much worse. | Week 8 |
| Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score | NPSI total score is based on 5 subscales evaluating different symptoms of neuropathic pain, each evaluated on a scale of 0 (no pain) to 10 (worst pain). The total score ranges from 0 to 100. A higher score indicates a worse outcome. | Baseline, Week 8 |
| Birmingham |
| Alabama |
| 35216 |
| United States |
| Lexicon Investigational Site (189) | Daphne | Alabama | 36526 | United States |
| Lexicon Investigational Site (215) | Guntersville | Alabama | 35976 | United States |
| Lexicon Investigational Site (115) | Chandler | Arizona | 85286 | United States |
| Lexicon Investigational Site (195) | Phoenix | Arizona | 85028 | United States |
| Lexicon Investigational Site (206) | Scottsdale | Arizona | 85258 | United States |
| Lexicon Investigational Site (102) | Tucson | Arizona | 85741 | United States |
| Lexicon Investigational Site (107) | Anaheim | California | 92801 | United States |
| Lexicon Investigational Site (173) | Canoga Park | California | 91303 | United States |
| Lexicon Investigational Site (179) | Escondido | California | 92025 | United States |
| Lexicon Investigational Site (161) | Fresno | California | 93710 | United States |
| Lexicon Investigational Site (112) | Greenbrae | California | 94904 | United States |
| Lexicon Investigational Site (204) | Huntington Beach | California | 92647 | United States |
| Lexicon Investigational Site (191) | Inglewood | California | 90301 | United States |
| Lexicon Investigational Site (163) | Lomita | California | 90717 | United States |
| Lexicon Investigational Site (169) | Long Beach | California | 90806 | United States |
| Lexicon Investigational Site (111) | Sacramento | California | 95821 | United States |
| Lexicon Investigational Site (126) | Sacramento | California | 95821 | United States |
| Lexicon Investigational Site (129) | San Diego | California | 92103 | United States |
| Lexicon Investigational Site (154) | San Diego | California | 92120 | United States |
| Lexicon Investigational Site (124) | Tustin | California | 92780 | United States |
| Lexicon Investigational Site (211) | Vista | California | 92081 | United States |
| Lexicon Investigational Site (171) | Walnut Creek | California | 94596 | United States |
| Lexicon Investigational Site (181) | Walnut Creek | California | 94598 | United States |
| Lexicon Investigational Site (119) | Brandon | Florida | 33511 | United States |
| Lexicon Investigational Site (194) | Brandon | Florida | 33511 | United States |
| Lexicon Investigational Site (177) | Daytona Beach | Florida | 32117 | United States |
| Lexicon Investigational Site (198) | Fleming Island | Florida | 32003 | United States |
| Lexicon Investigational Site (109) | Fort Myers | Florida | 33912 | United States |
| Lexicon Investigational Site (180) | Hollywood | Florida | 33024 | United States |
| Lexicon Investigational Site (188) | Jacksonville | Florida | 32256 | United States |
| Lexicon Investigational Site (164) | Miami | Florida | 33176 | United States |
| Lexicon Investigational Site (105) | New Port Richey | Florida | 34652 | United States |
| Lexicon Investigational Site (146) | Orlando | Florida | 32801 | United States |
| Lexicon Investigational Site (144) | Orlando | Florida | 32806 | United States |
| Lexicon Investigational Site (123) | Ormond Beach | Florida | 32174 | United States |
| Lexicon Investigational Site (182) | Plantation | Florida | 33317 | United States |
| Lexicon Investigational Site (133) | The Villages | Florida | 32159 | United States |
| Lexicon Investigational Site (138) | The Villages | Florida | 32162 | United States |
| Lexicon Investigational Site (131) | Winter Haven | Florida | 33880 | United States |
| Lexicon Investigational Site (103) | Winter Park | Florida | 32789 | United States |
| Lexicon Investigational Site (150) | Atlanta | Georgia | 30303 | United States |
| Lexicon Investigational Site (151) | Marietta | Georgia | 30060 | United States |
| Lexicon Investigational Site (172) | Chicago | Illinois | 60623 | United States |
| Lexicon Investigational Site (132) | Flossmoor | Illinois | 60422 | United States |
| Lexicon Investigational Site (185) | El Dorado | Kansas | 67042 | United States |
| Lexicon Investigational Site (178) | Newton | Kansas | 67114 | United States |
| Lexicon Investigational Site (186) | Wichita | Kansas | 67207 | United States |
| Lexicon Investigational Site (213) | Owensboro | Kentucky | 42303 | United States |
| Lexicon Investigational Site (170) | New Orleans | Louisiana | 70115 | United States |
| Lexicon Investigational Site (190) | New Orleans | Louisiana | 70119 | United States |
| Lexicon Investigational Site (121) | Boston | Massachusetts | 02115 | United States |
| Lexicon Investigational Site (140) | New Bedford | Massachusetts | 02740 | United States |
| Lexicon Investigational Site (225) | Waltham | Massachusetts | 02451 | United States |
| Lexicon Investigational Site (125) | Ann Arbor | Michigan | 48109 | United States |
| Lexicon Investigational Site (108) | Dearborn | Michigan | 48126 | United States |
| Lexicon Investigational Site (139) | Olive Branch | Mississippi | 38654 | United States |
| Lexicon Investigational Site (104) | Hazelwood | Missouri | 63042 | United States |
| Lexicon Investigational Site (174) | Kansas City | Missouri | 64114 | United States |
| Lexicon Investigational Site (184) | Springfield | Missouri | 65807 | United States |
| Lexicon Investigational Site (156) | St Louis | Missouri | 63110 | United States |
| Lexicon Investigational Site (116) | Papillion | Nebraska | 68046 | United States |
| Lexicon Investigational Site (216) | Las Vegas | Nevada | 89106 | United States |
| Lexicon Investigational Site (162) | Las Vegas | Nevada | 89123 | United States |
| Lexicon Investigational Site (142) | New York | New York | 100029 | United States |
| Lexicon Investigational Site (227) | Rochester | New York | 14609 | United States |
| Lexicon Investigational Site (167) | Schenectady | New York | 12304 | United States |
| Lexicon Investigational Site (122) | Westfield | New York | 14787 | United States |
| Lexicon Investigational Site (110) | Williamsville | New York | 14221 | United States |
| Lexicon Investigational Site (200) | Asheville | North Carolina | 28803 | United States |
| Lexicon Investigational Site (209) | Greensboro | North Carolina | 27410 | United States |
| Lexicon Investigational Site (212) | Monroe | North Carolina | 28112 | United States |
| Lexicon Investigational Site (106) | Morehead City | North Carolina | 28557 | United States |
| Lexicon Investigational Site (145) | Winston-Salem | North Carolina | 27103 | United States |
| Lexicon Investigational Site (220) | Beavercreek | Ohio | 45432 | United States |
| Lexicon Investigational Site (168) | Dayton | Ohio | 45424 | United States |
| Lexicon Investigational Site (148) | Norman | Oklahoma | 73069 | United States |
| Lexicon Investigational Site (210) | Oklahoma City | Oklahoma | 73102 | United States |
| Lexicon Investigational Site (187) | Eugene | Oregon | 97404 | United States |
| Lexicon Investigational Site (183) | Charleston | South Carolina | 29406 | United States |
| Lexicon Investigational Site (201) | Columbia | South Carolina | 29205 | United States |
| Lexicon Investigational Site (113) | Greenville | South Carolina | 29607 | United States |
| Lexicon Investigational Site (205) | North Charleston | South Carolina | 29405 | United States |
| Lexicon Investigational Site (202) | Rock Hill | South Carolina | 29730 | United States |
| Lexicon Investigational Site (157) | Summerville | South Carolina | 29486 | United States |
| Lexicon Investigational Site (160) | Memphis | Tennessee | 38119 | United States |
| Lexicon Investigational Site (192) | Austin | Texas | 78759 | United States |
| Lexicon Investigational Site (199) | Baytown | Texas | 77521 | United States |
| Lexicon Investigational Site (193) | Dallas | Texas | 75230 | United States |
| Lexicon Investigational Site (158) | Dallas | Texas | 75231 | United States |
| Lexicon Investigational Site (153) | Euless | Texas | 76040 | United States |
| Lexicon Investigational Site (114) | Flower Mound | Texas | 75028 | United States |
| Lexicon Investigational Site (196) | Harlingen | Texas | 78550 | United States |
| Lexicon Investigational Site (120) | Houston | Texas | 77030 | United States |
| Lexicon Investigational Site (197) | Houston | Texas | 77065 | United States |
| Lexicon Investigational Site (152) | Houston | Texas | 77074 | United States |
| Lexicon Investigational Site (214) | Katy | Texas | 77494 | United States |
| Lexicon Investigational Site (155) | Lewisville | Texas | 75057 | United States |
| Lexicon Investigational Site (223) | Mesquite | Texas | 75150 | United States |
| Lexicon Investigational Site (203) | San Antonio | Texas | 78229 | United States |
| Lexicon Investigational Site (159) | San Antonio | Texas | 78233 | United States |
| Lexicon Investigational Site (221) | San Antonio | Texas | 78240 | United States |
| Lexicon Investigational Site (101) | Salt Lake City | Utah | 84102 | United States |
| Lexicon Investigational Site (219) | Salt Lake City | Utah | 84107 | United States |
| Lexicon Investigational Site (224) | St. George | Utah | 84790 | United States |
| Lexicon Investigational Site (130) | Manassas | Virginia | 20110 | United States |
| Lexicon Investigational Site (165) | Norfolk | Virginia | 23510 | United States |