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NCT01323790 Clinical Trial

Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

Opioid-Induced Constipation (OIC) Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01323790
Other study ID # D3820C00005
Secondary ID 2011-001986-41
Status Completed
Phase Phase 3
First received March 24, 2011
Last updated June 1, 2015
Start date March 2011
Est. completion date September 2012

Study information
Verified date May 2015
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsCroatia: Agency for Medicinal Product and Medical DevicesHungary: National Institute of PharmacySpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• NKTR-118
12.5 mg oral tablet once daily
• NKTR-118
25 mg oral tablet once daily
• Placebo
Placebo to NKTR-118
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Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Belgium,  Croatia,  Czech Republic,  Hungary,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response (Responder/Non-responder) to Study Drug During Weeks 1 to 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. Baseline (Week 1) to end of treatment (Week 12) No
Secondary Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12 Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks. Baseline (Week 1) to end of treatment (Week 12) No
Secondary Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours 12 weeks No
Secondary Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12 12 weeks No
Secondary Change From Baseline in Degree of Straining A single-item straining question was asked via the eDiary: "How much did you strain during your bowel movement?" Patients responded on a 5 point Likert scale: 1=Not at all; 2=A little bit; 3=A moderate amount; 4=A great deal; 5=An extreme amount. A negative change from baseline indicates improvement. Baseline (Week 1) to end of treatment (Week 12) No
Secondary Change From Baseline in Stool Consistency (Bristol Stool Scale) Patients rated stool consistency through completion of the BSS after each BM. The 7 stool types are: 1. Separate hard lumps, like nuts (hard to pass); 2. Sausage-shaped, but lumpy; 3. Like sausage, but with cracks on its surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces. A positive change from baseline indicates improvement. Baseline (Week 1) to end of treatment (Week 12) No
Secondary Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement) A single-item question on the completeness of evacuation, developed and validated through 1:1 interviews with OIC patients, was asked via the eDiary: "Did you feel like your bowels were completely empty after the bowel movement?" Patients provided a yes or a no response. A positive change from baseline indicates improvement. Baseline (Week 1) to end of treatment (Week 12) No
Secondary Change From Baseline in Mean Spontaneous Bowel Movements/Week The number of spontaneous bowel movements/week was determined from the patient's eDiary. Baseline (Week 1) to end of treatment (Week 12) No
Secondary Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours in the Laxative Inadequate Response (LIR) Subgroup Time to first post-dose laxation without the use of rescue laxatives within the last 24 hours was calculated in hours as: Date/Time of first post-dose laxation without rescue - First dose date/time. Baseline (Week 1) to end of treatment (Week 12) No
Secondary Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement. Baseline (Week 1) to end of treatment (Week 12) No
Secondary Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement. Baseline (Week 1) to end of treatment (Week 12) No
See also
  Status Clinical Trial Phase
Completed NCT01333540 - A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation Phase 2
Completed NCT01309841 - Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation Phase 3
Completed NCT01395524 - A 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 Constipation Phase 3
Recruiting NCT05588323 - Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids Phase 1/Phase 2
Completed NCT01336205 - Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation Phase 3

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