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NKTR-118

Phase 3

Opioid-Induced Constipation (OIC) | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: Feb 23, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment2,498
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01395524A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced ConstipationPHASE3 COMPLETED 302 — — Jul 1, 2011Sep 1, 2012Feb 23, 2017116 United States, Australia +2
NCT01336205Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced ConstipationPHASE3 COMPLETED 844 — — Apr 1, 2011Dec 1, 2012Oct 20, 2014169 United States
NCT01309841Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced ConstipationPHASE3 COMPLETED 652 — — Mar 1, 2011Aug 1, 2012Jun 1, 2015117 United States, Australia +2
NCT01323790Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced ConstipationPHASE3 COMPLETED 700 — — Mar 1, 2011Sep 1, 2012Jun 2, 2015120 United States, Belgium +6
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Study Endpoints
Primary Endpoints
Incidence of Patients Experiencing at Least One Adverse Event (AE)
Baseline (Week 0) to end of the follow-up period (Week 14)

The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.

Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
Baseline (Week 0) to end of the follow-up period (Week 14)

The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.

Incidence of Patients Experiencing Severe Adverse Events (SAEs)
Baseline (Week 0) to end of the follow-up period (Week 14)

The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.

Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12
Baseline (Week 1) to end of treatment (Week 12)

Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.

Secondary Endpoints
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)
Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)
Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12
Baseline (Week 1) to end of treatment (Week 12)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NKTR-118 12.5mgEXPERIMENTAL -
NKTR-118 25mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
1EXPERIMENTALOral Treatment
2ACTIVE_COMPARATOROral treatment
3PLACEBO_COMPARATOROral treatment
Interventions
NameTypeDescription
NKTR-118DRUG12.5 mg oral tablet once daily
PlaceboDRUGOral tablet intake once daily
Usual careDRUGAs prescribed by the investigator
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Eligibility Criteria
Age Range18 Years — 84 Years
SexALL
Healthy VolunteersNo
Study Sites116

Inclusion Criteria: * Must have completed the 12-week study D3820C00004 through Visit 8. * Provision of written informed consent prior to any study-specific procedures. * Men and women who were between the ages of \>18 and \<85 years at the time of the screening visit for study D3820C00004. * Conti...

Countries:United StatesAustraliaGermanySlovakiaBelgiumCroatiaCzechiaHungarySpainSwedenUnited Kingdom
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