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Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
Phase 3 trial testing placebo in Non-cancer Pain in 174 participants. Terminated before completion.
| Lead sponsor | Shire |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 174 |
| Start date | 19 May 2010 |
| Primary completion | 13 August 2012 |
| Estimated completion | 13 August 2012 |
| Sites | 1 location across Belgium |
Shire — full company profile →
18 and older, any sex, with Non-cancer Pain or Opioid Induced Constipation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 39.8 | |
| Prucalopride | 48.8 |
| Group | Value | 95% CI |
|---|---|---|
| Prucalopride | 2.827 | ± 1.5989 |
| Group | Value | 95% CI |
|---|---|---|
| Prucalopride | 6.107 | ± 2.8839 |
| Group | Value | 95% CI |
|---|---|---|
| Prucalopride | 3.179 | ± 1.9066 |
| Group | Value | 95% CI |
|---|---|---|
| Prucalopride | 6.615 | ± 2.5758 |
Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Prucalopride |
|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Hepatitis A | Infections and infestations | — | — |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Placebo | Prucalopride |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Flatulence | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Influenza | Infections and infestations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Rectal hemorrhage | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Intestinal obstruction, Hepatitis A, Breast cancer, Pulmonary embolism.
Data from ClinicalTrials.gov NCT01117051 adverse events section.
The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from opioid induced constipation.
No peer-reviewed publications indexed yet for this trial.
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