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This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label 6-11 years of age: Eluxadoline 50mg | Experimental | Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day. |
|
| Open Label 12-17 years of age: Eluxadoline 100 mg | Experimental | Eluxadoline one 100mg tablet, oral administration, twice daily with food. May use 25mg tablets to administer 100mg dose. Take at approximately the same time each day. |
|
| Double Blind 6-11 years of age: Eluxadoline 25mg | Experimental | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
|
| Double Blind 6-11 years of age: Eluxadoline 50mg | Experimental | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25mg Eluxadoline | Drug | Oral Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | 52 weeks | |
| Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator | 52 weeks | |
| Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator | 52 weeks | |
| Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator | 52 weeks | |
| Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline | 52 weeks | |
| Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline | 52 weeks |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kindred Medical Institute, LLC /ID# 227595 | Corona | California | 92879 | United States | ||
| Valencia Medical & Research Center /ID# 246221 |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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|
| Double Blind 12-17 years of age: Eluxadoline 25mg | Experimental | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
|
| Double Blind 12-17 years of age: Eluxadoline 50mg | Experimental | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
|
| Double Blind 12-17 years of age: Eluxadoline 100mg | Experimental | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
|
| 100mg Eluxadoline | Drug | Oral Tablets |
|
| Miami |
| Florida |
| 33165 |
| United States |
| Florida Research Center, Inc. /ID# 227597 | Miami | Florida | 33174 | United States |
| Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600 | Stockbridge | Georgia | 30281 | United States |
| IPS Research Company /ID# 227594 | Oklahoma City | Oklahoma | 73106 | United States |
| Preferred Primary Care Physicians, Inc. /ID# 227596 | Pittsburgh | Pennsylvania | 15236 | United States |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C583636 | eluxadoline |
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