Non-cancer PainPhase 3OICNCT01117051
Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
A Phase 3 study testing prucalopride in people with Non-cancer Pain and Opioid Induced Constipation, run by Shire at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-cancer Pain, Opioid Induced Constipation
- What is being tested?
- prucalopride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteBelgium
- Study dates
- 19 May 2010to 13 Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant, non-breast-feeding female outpatient ≥18 years.
- Has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids;has been on stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on stable daily dose of opioids for at least 15 weeks after Visit 1.
- Subject is suffering from OIC (i.e. secondary to chronic opioid use).
- Subject agrees to stop his/her laxative treatment and is willing to use rescue medication.
- Main exclusion criteria to be assessed at screening:
- Constipation is thought to be drug-induced (except for opioids)
Show all 9Show fewer
- Disallowed medication is being used
- Subject was on chronic therapy for chronic constipation prior to start of opioid therapy
- Subject is suffering from secondary causes of chronic constipation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride in Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
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.
- Conditions
- Non-cancer Pain, Opioid Induced Constipation
- Being tested
- placebo, prucalopride
- Keywords
- Opioid induced constipation/prucalopride chronic non-cancer pain, Subjects with chronic non-cancer pain suffering from OIC
- Medical subject headings
- Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
placebo
prucaloprideDrug
1 or 2 mg prucalopride once daily before breakfast
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
| Resolor | Active comparator | prucalopride Receives: Drug: prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
Plasma Concentration of Prucalopride at Week 2
Measured: Week 2
Plasma Concentration of Prucalopride at Week 8
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study start19 May 2010
- Primary completion13 Aug 2012
- Study completion13 Aug 2012
Why it stopped: The study was stopped by the sponsor based on a non-safety related business priority decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117051
- Sponsor's protocol ID
- M0001-C301
- Other IDs
- SPD555-301, 2009-015652-20, 2009
- Acronym
- OIC
- Status last verified
- May 2021
- First submitted
- 29 Apr 2010
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Prucalopride in Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
- ClinicalTrials.gov ID
- NCT01117051
- Acronym / sponsor ID
- OIC / M0001-C301
- Conditions
- Non-cancer Pain, Opioid Induced Constipation
- Keywords
- Opioid induced constipation/prucalopride chronic non-cancer pain, Subjects with chronic non-cancer pain suffering from OIC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped by the sponsor based on a non-safety related business priority decision
- Enrolment
- 174 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 19 May 2010 (actual)
- Primary completion
- 13 Aug 2012 (actual)
- Study completion
- 13 Aug 2012 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Posted 26 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboplacebo |
| Resolor | Active comparator | Drug: prucaloprideprucalopride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or non-pregnant, non-breast-feeding female outpatient ≥18 years.
- Has chronic pain of any aetiology (except cancer pain) requiring daily maintenance treatment with opioids;has been on stable daily opioid dose during at least the previous 2 weeks; and is expected to remain on stable daily dose of opioids for at least 15 weeks after Visit 1.
- Subject is suffering from OIC (i.e. secondary to chronic opioid use).
- Subject agrees to stop his/her laxative treatment and is willing to use rescue medication.
- Constipation is thought to be drug-induced (except for opioids)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboplacebo | Drug | placebo |
| prucalopride1 or 2 mg prucalopride once daily before breakfast | Drug | Resolor |
Primary outcome
Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week
Time frame: 12 weeks
A bowel movement (BM) was defined as spontaneous if no laxatives were taken in the 24 hours preceding that BM.
2 secondary outcomes
Plasma Concentration of Prucalopride at Week 2
Time frame: Week 2
Plasma Concentration of Prucalopride at Week 8
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing prucalopride in people with Non-cancer Pain and Opioid Induced Constipation, run by Shire at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Subjects With an Average Frequency of >=3 Spontaneous Bowel Movements Per Week (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.