Phase 3 N=439 Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
Opioid-induced Bowel Dysfunction
Primary: Number of Participants Classified as Treatment Responders Within 12 Weeks — 59; 41 Participants
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Phase 3 N=437 Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
Opioid-Induced Bowel Dysfunction
Primary: Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8 — 2.4; 2.6 Spontaneous Bowel…
Phase 3 N=439 Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone
Opioid-Induced Bowel Dysfunction
Primary: Mean Weekly Spontaneous Bowel Movements at Week 8 — 2.4; 3.2 SBMs/Week
Phase 3 N=439 Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
Opioid-Induced Bowel Dysfunction
Primary: Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month — 1.4; 4.9; 4.9; 5.0 Weekly SBMs
Phase 2 N=131 Evaluation of the Efficacy and Safety of ADL5945 for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain
Opioid Induced Constipation
Primary: Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment — 1.96; 3.42; 1.44 Number of SBMs/week
Phase 2 N=81 Evaluation of the Efficacy and Safety of ADL5945 Once Daily for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain
Constipation
Primary: Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment — 1.40; 2.58 Number of SBMs/week
Phase 2 N=72 Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain
Opioid Induced Bowel Dysfunction
Primary: Number of Participants With Adverse Events — 9; 6; 6; 5 participants
Phase 2 N=254 Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain
Opioid-Induced Constipation
Primary: Change From Baseline in 8-Week SBM Frequency Rate (SBMs/Week) — 1.474; 2.799; 3.382 Number of SBMs per week — p=0.0035
Phase 2 N=122 Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain
Constipation
Primary: Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment — 0; 0; 0; 7 Participants
Phase 2 N=128 Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain
Constipation
Primary: Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment — 2; 3; 2; 5 Participants
N/A N=64 Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation
Constipation
Primary: Change in Patient Assessment of Constipation (PAC) - Symptoms (Sym) — -0.22; -0.29 units on a scale — p=<0.05
Phase 3 N=547 Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
Opioid-induced Constipation
Primary: Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response — 47.6; 34.6 percentage of participants — p=0.0020
Phase 2 N=40 Naloxone SR Capsules in Patients With Opioid Induced Constipation
Chronic Pain · Opioid Induced Constipation
Primary: Incidence and Severity of Treatment Emergent Adverse Events on Single Dosing. — 8; 5; 4; 6 participants
Phase 3 N=553 Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
Opioid-induced Constipation
Primary: Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response — 52.5; 33.6 percentage of participants — p=<0.0001
Phase 3 N=596 A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease
Joint Diseases · Arthritis · Osteoarthritis
Primary: 5-Day Sum of Pain Intensity Difference (SPID5) — 98.6; 153.1; 161.8; 218.4 Units on a scale — p=0.007
Phase 3 N=460 Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain
Constipation
Primary: Percentage of Patients Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours of the First Dose — 34.2; 9.9 percentage of participants — p=<0.001
Phase 4 N=80 Intrathecal Opioids for Colorectal Resection
Colorectal Surgery · Pain, Postoperative · Analgesic, Opioid
Primary: Postoperative Pain Control — 4.5; 1.6; 1.75; 2.75 score on a scale
Phase 4 N=12 Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation
Constipation Drug Induced
Primary: Occurrence of Bowl Movement — 2; 2; 5 Participants
Phase 3 N=50 A Comparison of Targinact vs. Oxycodone on Gut Function After Colorectal Surgery
Postoperative Pain · Postoperative Nausea and Vomiting
Primary: Prevalence of Postoperative Gut Dysfunction — 13; 15 Participants — p=0.264
Phase 3 N=5,521 Opioid Prescription After Cesarean Trial
Pregnancy Related · Opioid Use · Pain
Primary: Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory — 1497; 1535 Participants
Phase 2 N=244 A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
Opioid-induced Constipation
Primary: Change From Baseline to Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week — 1.42; 1.98; 3.37; 3.64 spontaneous bowel movements…
Phase 4 N=276 To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation
Opioid Induced Constipation
Primary: Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment — 124; 118; 4 Participants
N/A N=29 Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults
Substance Withdrawal Syndrome
Primary: Description of Signs and Symptoms of OIWS in Patients Who Scored Positive for Withdrawal Syndrome (OIWS) According to Diagnostic and Statistical Manual of Mental…
Phase 2 N=12 Methylnaltrexone for Opioid-induced Constipation in Cancer Patients
Neoplasms · Constipation · Opioid-Related Disorders
Primary: Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone — 33 percentage of participants
Phase 2 N=207 A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
Opioid Induced Constipation (OIC)
Primary: Change From Baseline in Spontaneous Bowel Movements (SBMs) Per Week During Week 1 — 1.8; 2.6; 1.9; 3.6 Number of SBMs/week — p=0.7781
N/A N=100 Effect of Electroacupuncture on Opioid-induced Constipation in Patients With Cancer
Opioid-induced Constipation in Patients With Cancer
Primary: Number of Participants With Response — 19; 4 participants
Phase 2 N=565 Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)
Irritable Bowel Syndrome With Diarrhea
Primary: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With…
Phase 3 N=844 Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Opioid-Induced Constipation (OIC)
Primary: Incidence of Patients Experiencing at Least One Adverse Event (AE) — 437; 195 Participants
Phase 3 N=700 Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Opioid-Induced Constipation (OIC)
Primary: Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12 — 81; 92; 68 Number of patients — p=0.202
Phase 3 N=652 Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Opioid-Induced Constipation (OIC)
Primary: Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12 — 87; 95; 63 Number of patients — p=0.015