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| ID | Type | Description | Link |
|---|---|---|---|
| SPD555-301 | Other Identifier | Shire Development LLC | |
| 2009-015652-20 | EudraCT Number |
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The study was stopped by the sponsor based on a non-safety related business priority decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo |
|
| Resolor | Active Comparator | prucalopride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | placebo |
| |
| prucalopride |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week | A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Prucalopride at Week 2 | Week 2 | |
| Plasma Concentration of Prucalopride at Week 8 | Week 8 |
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Inclusion criteria to be assessed at screening:
Main exclusion criteria to be assessed at screening:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leuven | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo once daily before breakfast for up to 12 weeks |
| FG001 | Prucalopride | 1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population was used which includes all subjects who were randomized into the study and who had received at least 1 dose of investigational product. 174 subjects were randomized but 5 were not treated (n = 169).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo once daily before breakfast for up to 12 weeks |
| BG001 | Prucalopride | 1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week | A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM. | Intent-to-Treat (ITT) population includes all subjects who were randomized into the study and who had received at least 1 dose of investigational medication. | Posted | Number | percentage of subjects | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | once daily before breakfast for up to 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
Due to the early termination of the study, results should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C406662 | prucalopride |
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| Drug |
1 or 2 mg prucalopride once daily before breakfast |
|
| Lost to Follow-up |
|
| Did not meet in-/exclusion criteria |
|
| Sponsor's decision |
|
| Surgical procedure |
|
| Randomized by mistake |
|
| Convenience issue |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | All randomized subjects (n = 174) | Count of Participants | Participants |
|
|
|
|
| Secondary | Plasma Concentration of Prucalopride at Week 2 | ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation) | Posted | Mean | Standard Deviation | ng/ml | Week 2 |
|
|
|
| Secondary | Plasma Concentration of Prucalopride at Week 8 | ITT (subjects in the ITT whose post-dose samples were collected outside the 5-hour sampling window were not used in the plasma concentration calculation) | Posted | Mean | Standard Deviation | ng/ml | Week 8 |
|
|
|
| 2 |
| 83 |
| 30 |
| 83 |
| EG001 | Prucalopride | 1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks | 2 | 86 | 30 | 86 |
| Hepatitis A | Infections and infestations |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
|
| Flatulence | Gastrointestinal disorders |
|
| Abdominal pain upper | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Abdominal pain | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Influenza | Infections and infestations |
|
| Headache | Nervous system disorders |
|
| 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 |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |