NCT01275755

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

Completed Phase 2 Results posted Last updated 15 November 2018

What this trial tests

Phase 2 trial testing Placebo in Constipation in 81 participants. Completed in 15 July 2011.

Timeline

19 January 2011

Primary endpoint
15 July 2011

15 July 2011

Quick facts

Lead sponsor	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	81
Start date	19 January 2011
Primary completion	15 July 2011
Estimated completion	15 July 2011

Drugs / interventions tested

• Placebo
• ADL5945 0.25 mg — full drug profile →

Conditions studied

• Constipation — all drugs for Constipation →

Sponsor

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →

Who can join

Adults 18 to 75, any sex, with Constipation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in the Weekly Average of Spontaneous Bowel Movements (SBMs) During Treatment Primary · Baseline, Weeks 1 through 4 of treatment

An SBM was defined as a bowel movement (BM) with no laxative use in the previous 24 hours. Each weekly SBM average was calculated as follows: (7 × number of SBMs) / (number of days with nonmissing data). The overall SBM rate for the 4-week double-blind treatment period was calculated as follows: (the average of the first week + the average of the second week + the average of the third week + the average of the fourth week) / 4.

Group	Value	95% CI
Placebo	1.40	± 0.26
ADL5945 0.25 mg	2.58	± 0.34

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 2.5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/41 (0%)

Deaths: —

ADL5945 0.25 mg

Serious: 1/40 (3%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Placebo	ADL5945 0.25 mg
Cardiac Arrest	Cardiac disorders	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Placebo	ADL5945 0.25 mg
Abdominal Pain Upper	Gastrointestinal disorders	—	—
Abdominal Pain	Gastrointestinal disorders	—	—
Bronchitis	Respiratory, thoracic and mediastinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—

Most-reported serious reactions: Cardiac Arrest.

Data from ClinicalTrials.gov NCT01275755 adverse events section.

Sponsor's own description

Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI tract. The most common symptoms associated with the effects of opioids are constipation and nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of long-term opioid therapy.

The primary objective of this study was to compare ADL5945 once daily, a MOR antagonist, with placebo in the treatment of opioid-induced constipation (OIC) in adults taking long-term opioid therapy for chronic noncancer pain.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.