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XP19986

Phase 2

GERD | Small molecule | Gastrointestinal |Indivior Pharmaceuticals, Inc.|Trials Updated: Sep 14, 2016

XP19986 target and mechanism

ModalitySmall molecule

Also known as XP19986 CR

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment58

FDA Designations

No designations recorded

XP19986 clinical trials

XP19986 · 1 trial · 1 indication

Phase 2 1
NCT00838396A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux DiseaseGERD
COMPLETED58 Analytics
PHASE2COMPLETED
A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease
GERDUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary efficacy assessment endpoint of this study was the total number of reflux episodes (acid and non-acid) comparing study drug to placebo
12 hours

Secondary Endpoints

Reflux episodes (acid and non-acid) during each treatment period at various time intervals, dose/exposure to reflux rate relationship, acid reflux events, non-acid reflux events, and GERD symptoms.
12 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
XP19986 CREXPERIMENTALOn either study Day 1 or study Day 5 (after completion of the minimum 3-day washout period), participants received a single dose of XP19986 10, 20, 40 or 60 mg.
Placebo for XP19986 CRPLACEBO_COMPARATOROn either study Day 1 or study Day 5 (after completion of the minimum 3-day washout period), participants received a single dose of placebo.

Interventions

NameTypeDescription
XP19986 CRDRUG -
Placebo for XP19986 CRDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. History of GERD symptoms (e.g. heartburn episodes) at least 3 times per week 2. Discontinuation of drugs used to treat GERD (PPIs, H2-blockers) and/or drugs known to cause GERD symptoms (e.g. nonsteroidal anti-inflammatory drugs \[NSAIDs\]) for 7 days prior to baseline (Visit...

Countries:United States
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Competitive Landscape -GERD 10 trials

Top 1 of 5 competitors

CompanyTickerTrialsLead PhaseDrugs
Phathom Pharmaceuticals, Inc.PHAT2PHASE3Vonoprazan
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Frequently asked questions about XP19986

What is XP19986?

XP19986 is an investigational small molecule developed by Indivior Pharmaceuticals, Inc. (ticker INDV) for gastroesophageal reflux disease, or GERD. It is a controlled release formulation and has been studied in a Phase 2 clinical trial. XP19986 is not approved and remains in clinical development.

What is XP19986 used for?

XP19986 is being developed for the treatment of gastroesophageal reflux disease, commonly known as GERD. It is an investigational therapy and has not been approved for any indication. The clinical program has focused on evaluating its efficacy and safety in patients with GERD.

Who makes XP19986?

XP19986 is developed by Indivior Pharmaceuticals, Inc., which trades under the ticker INDV. Indivior is the sponsor of the clinical program for XP19986 in gastroesophageal reflux disease.

What phase is XP19986 in?

XP19986 is in Phase 2 clinical development. It has completed one Phase 2 trial in patients with gastroesophageal reflux disease. The drug is investigational and has not been approved by the FDA or any regulatory authority.

What clinical trials is XP19986 in?

XP19986 has been evaluated in one completed Phase 2 trial, NCT00838396, titled a study to evaluate the efficacy and safety of controlled release arbaclofen placarbil (XP19986) in patients with gastroesophageal reflux disease. The trial enrolled 58 patients in the United States and was randomized, double-blind, and placebo-controlled.

Is XP19986 the same as XP19986 CR?

Yes, XP19986 CR is another name for XP19986. The CR stands for controlled release, referring to the formulation used in the clinical trial. Both names refer to the same investigational small molecule being developed by Indivior Pharmaceuticals for gastroesophageal reflux disease.