Sickle Cell DiseasePhase 4SWIMNCT00880373
Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease - Sickle With Ibuprofen & Morphine
A Phase 4 study testing Ibuprofen and Diamorphine or Morphine in people with Sickle Cell Disease, run by London North West Healthcare NHS Trust at 2 sites in United Kingdom.
Trial summary
The use of oral ibuprofen combined with Opioid (Morphine or Diamorphine) administered through patient controlled analgesia (PCA) will be clinically effective for acute pain crisis in adults with sickle cell disease (SCD). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Ibuprofen and Diamorphine or Morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2011to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients with SCD of any phenotype
Who cannot join
- Patient has a history of allergic reaction to either diamorphine/morphine or ibuprofen
- Patient has contraindications to diamorphine/morphine or ibuprofen, e.g. peptic ulcer disease, non-steroidal anti-inflammatory drug (NSAID)-induced asthma
- Patient in a drug dependency programme
- Patient is on renal dialysis
- Stroke within the last 6 weeks
- Platelet count less than 50 x 10^9/l
Show all 13Show fewer
- Patient is pregnant or breastfeeding
- Doctor unwilling to randomise the patient for other reasons
- Previous participation in the trial
- Patient receiving drug treatment with which opioids or NSAIDs are likely to interact significantly
- Stage 1 - 5 chronic kidney disease (ref Appendix 2), including urine protein: creatinine ratio of >50 (Because the ibuprofen dose is substantial it is felt that precautions should be taken to exclude those who have any signs of chronic kidney disease. One of the signs of kidney disease is "persistent proteinuria". Therefore, the patient who intermittently has proteinuria(which could be due to other reasons) could still participate.)
- Oxygen saturation by pulse oximetry <94%
- Participation in another clinical trial within the last month
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
North West London Hospitals NHS Trust
London, NW10 7NS
Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: An Evaluation of the Effectiveness of Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease: a Double-blind, Placebo-controlled Randomised Trial
The use of oral ibuprofen combined with Opioid (Morphine or Diamorphine) administered through patient controlled analgesia (PCA) will be clinically effective for acute pain crisis in adults with sickle cell disease (SCD).
Read the detailed description
Pain from vaso-occlusion in sickle cell disease (SCD) is persistent, and its management continues to pose a challenge to practitioners. Opioids are recommended for the treatment of severe acute SCD pain, and have been used successfully within the hospital setting. Non-steroidal Anti-Inflammatory Drugs (NSAIDs) are recommended for acute SCD pain, however there is no clear evidence for the effectiveness of oral NSAIDs in combination with parenteral opioids in adults with SCD.Data from acute pain research suggests that oral ibuprofen is one of the best NSAIDs for combination treatment with morphine via PCA.
This is a randomised controlled trail to evaluate the effectiveness of oral ibuprofen plus intravenous Diamorphine or morphine via PCA. The results will provide the evidence needed to recommend whether or not ibuprofen should be used in acute SCD pain.
- Conditions
- Sickle Cell Disease
- Being tested
- Ibuprofen, Placebo, Diamorphine or Morphine
- Keywords
- Sickle Cell Disease, Pain, Ibuprofen, Morphine, Diamorphine, Patient Controlled Analgesia
- Medical subject headings
- Anemia, Sickle Cell, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Oral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days
PlaceboDrug
Matching placebo three times daily for 4 days
Diamorphine or MorphineDrug
Diamorphine or Morphine by PCA
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Diamorphine or Morphine by PCA and oral ibuprofen Receives: Drug: Ibuprofen; Drug: Diamorphine or Morphine |
| 2 | Placebo comparator | Diamorphine or Morphine by PCA and oral placebo Receives: Drug: Placebo; Drug: Diamorphine or Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient controlled analgesia (PCA)diamorphine or morphine consumption
Measured: 4 days
Secondary outcomes (1)
Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
- Study startMar 2011
- Primary completionMar 2014 (estimated)
- Study completionAug 2014 (estimated)
Why it stopped: The funding withdrawal and early termination of the trial is based upon lack of suitable recruitment figures in order to reach the required trial endpoints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Investigators
- Kofi A Anie, PhD, Principal investigator, London North West Healthcare NHS TrustGavin Cho, MD, Study chair, London North West Healthcare NHS TrustMark Layton, MD, Principal investigator, Imperial College LondonSarah Meredith, MD, Study director, MRC Clinical Trials UnitCaroline Dore, BSc, Study director, MRC Clinical Trials Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880373
- Sponsor's protocol ID
- HTA 07/48/01
- Other IDs
- ISRCTN97241637
- Acronym
- SWIM
- Status last verified
- Dec 2012
- First submitted
- 9 Apr 2009
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cho G, Anie KA, Buckton J, Kiilu P, Layton M, Alexander L, Hemmaway C, Sutton D, Amos C, Dore CJ, Kahan B, Meredith S. SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt. BMJ Open. 2016 Jun 9;6(6):e011276. doi: 10.1136/bmjopen-2016-011276.
PubMed 27288381
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effectiveness of Ibuprofen and Opioid (Morphine or Diamorphine) for Acute Pain in Sickle Cell Disease: a Double-blind, Placebo-controlled Randomised Trial
- ClinicalTrials.gov ID
- NCT00880373
- Acronym / sponsor ID
- SWIM / HTA 07/48/01
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Pain, Ibuprofen, Morphine, Diamorphine, Patient Controlled Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The funding withdrawal and early termination of the trial is based upon lack of suitable recruitment figures in order to reach the required trial endpoints.
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 13 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of oral ibuprofen combined with Opioid (Morphine or Diamorphine) administered through patient controlled analgesia (PCA) will be clinically effective for acute pain crisis in adults with sickle cell disease (SCD).
Detailed description
Pain from vaso-occlusion in sickle cell disease (SCD) is persistent, and its management continues to pose a challenge to practitioners. Opioids are recommended for the treatment of severe acute SCD pain, and have been used successfully within the hospital setting. Non-steroidal Anti-Inflammatory Drugs (NSAIDs) are recommended for acute SCD pain, however there is no clear evidence for the effectiveness of oral NSAIDs in combination with parenteral opioids in adults with SCD.Data from acute pain research suggests that oral ibuprofen is one of the best NSAIDs for combination treatment with morphine via PCA.
This is a randomised controlled trail to evaluate the effectiveness of oral ibuprofen plus intravenous Diamorphine or morphine via PCA. The results will provide the evidence needed to recommend whether or not ibuprofen should be used in acute SCD pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Ibuprofen, Drug: Diamorphine or MorphineDiamorphine or Morphine by PCA and oral ibuprofen |
| 2 | Placebo comparator | Drug: Placebo, Drug: Diamorphine or MorphineDiamorphine or Morphine by PCA and oral placebo |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with SCD of any phenotype
Key exclusion criteria (13 listed)
- Patient has a history of allergic reaction to either diamorphine/morphine or ibuprofen
- Patient has contraindications to diamorphine/morphine or ibuprofen, e.g. peptic ulcer disease, non-steroidal anti-inflammatory drug (NSAID)-induced asthma
- Patient in a drug dependency programme
- Patient is on renal dialysis
- Stroke within the last 6 weeks
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 |
|---|---|---|
| IbuprofenOral ibuprofen 800 mg three times daily for a total of 2400 mg per day for 4 days | Drug | 1 |
| PlaceboMatching placebo three times daily for 4 days | Drug | 2 |
| Diamorphine or MorphineDiamorphine or Morphine by PCA | Drug | 1, 2 |
Primary outcome
Patient controlled analgesia (PCA)diamorphine or morphine consumption
Time frame: 4 days
1 secondary outcome
Rapidity of pain control - time to achieve a pain score of 4 on a standard 10-point numeric rating scale
Time frame: 4 days
Results and safety
The study was stopped early (reason given: The funding withdrawal and early termination of the trial is based upon lack of suitable recruitment figures in order to reach the required trial endpoints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Derived from this study: PubMed 27288381Cho G, Anie KA, Buckton J, Kiilu P, Layton M, Alexander L, Hemmaway C, Sutton D, Amos C, Dore CJ, Kahan B, Meredith S. SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt. BMJ Open. 2016 Jun 9;6(6):e011276. doi: 10.1136/bmjopen-2016-011276.
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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.
Kofi A Anie, PhD principal investigator
London North West Healthcare NHS Trust
Gavin Cho, MD study chair
London North West Healthcare NHS Trust
Mark Layton, MD principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen and Diamorphine or Morphine in people with Sickle Cell Disease, run by London North West Healthcare NHS Trust at 2 sites in United Kingdom.
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 1 inclusion and 13 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 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The funding withdrawal and early termination of the trial is based upon lack of suitable recruitment figures in order to reach the required trial endpoints.). Results are not available in the source record.
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?
Patient controlled analgesia (PCA)diamorphine or morphine consumption (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00880373, which also lists 1 linked publication.
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 4 Dec 2012.