Diabetes MellitusPhase 2/3NCT00370656
Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep
A Phase 2/3 study testing Pregabalin, Duloxetine and Amitriptyline in people with Diabetes Mellitus and Peripheral Neuropathies, run by University of Surrey at 3 sites in United Kingdom.
Trial summary
The purpose of this study is to assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing pain in diabetic patients as assessed by Brief Pain Inventory (BPI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Peripheral Neuropathies
- What is being tested?
- Pregabalin, Duloxetine and Amitriptyline
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Feb 2007to May 2009
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or above
- Have a diagnosis of Diabetes mellitus for at least a year
- Agree not to smoke whilst resident in the CRC
- Able to understand the patient information sheet and provide written informed consent
- Score above 12 on the LANSS
- Have neuropathic pain of diabetic origin
- Score above 25 on MMSE
- Willing to withdraw, under the guidance of their diabetologist, from any current pain medication prior to their first visit to the sleep laboratory. Duration of withdrawal will be at least equivalent to 5 half-lives and will be of a relevant duration given the particular medication used.
Who cannot join
- There is evidence of an end stage disease of a major system (hepatic, renal, respiratory, haematologic (PA), immunologic, cardiovascular, inflammatory, rheumatology, active infections, peripheral vascular disease, untreated endocrine(hypothyroid)
- There is evidence of a recent ischaemic event
- There is evidence of recurrent and/or severe hypoglycemia requiring assistance in last 3 years
- Evidence of sleep pathology that would interfere with the assessment of treatment (assessed on habituation night)
- Currently receiving treatment for malignancy
- Suffer from seizures including epilepsy
Show all 14Show fewer
- There is evidence of a history of dependence on or abuse of alcohol/recreational drugs
- Need to use a wheel chair (incompatible with studies in a sleep laboratory)
- Involved in a clinical trial in last 3 months
- Pregnant, lactating or inadequate contraception
- Vision inadequate for the performance tests (as assessed at screening)
- Colour Blind
- Will not co-operate with study procedures
- Will not give permission to inform GP
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
University of Surrey Clinical Research Centre
Guildford, Surrey, GU2 7XP
Poole General Hospital
Poole, Dorset, BH15 2JB
About this study
Official title: A Double-blind, Randomised, Parallel Groups Investigation Into the Effects of Pregabalin, Duloxetine and Amitriptyline on Aspects of Pain, Sleep, and Next Day Performance in Patients Suffering From Diabetic Peripheral Neuropathy
The purpose of this study is to assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing pain in diabetic patients as assessed by Brief Pain Inventory (BPI).
Read the detailed description
Little is understood concerning the interaction of pain with sleep. Pain may disrupt sleep leading to daytime sleepiness and poor sleep can increase the perception of pain. There is uncertainty concerning the most effective way in which medication could be used to ease pain and poor sleep in patients such as those with diabetic peripheral neuropathy. Various drugs have been tried or proposed, and these include amitriptyline, pregabalin and duloxetine.
Amitriptyline is believed to relieve pain and improve sleep, though there is little evidence of its beneficial effects on sleep. Furthermore, even at low doses, it affects reaction time, attention, memory, information processing.
In two studies with duloxetine, it has been shown to significantly reduce pain compared with placebo, although little data are available on the usefulness of this compound in the management of pain with poor sleep.
Pregabalin has been shown to be effective in reducing pain, and therefore improving sleep. It has also been demonstrated that it has limited potential to affect daytime cognition. In another study gabapentin (a compound structurally related to pregabalin) demonstrated superior efficacy in the management of pain compared to amitriptyline.
Therefore this study will assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing pain associated with diabetes and poor sleep.
As the incidence of diabetes is predicted to increase in future years and as a consequence so will the cases of diabetic peripheral neuropathy (DPN), this research will serve to provide essential information on sleep and DPN which will be beneficial now and in the future.
- Conditions
- Diabetes Mellitus, Peripheral Neuropathies
- Being tested
- Pregabalin, Duloxetine, Amitriptyline
- Keywords
- Diabetic Peripheral Neuropathy
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
capsule, 150mg bd, 300mg bd
DuloxetineDrug
Capsule, 60mg on, 60mg bd
AmitriptylineDrug
Capsule. 25 mg bd, 25 mg om and 50 mg on
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory.
Measured: December 2008
Secondary outcomes (1)
Whether there has been an improvement in sleep continuity and subjective sleep, morning after cognitive and psychomotor performance, and quality of life (QoL).
Measured: December 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2006 (estimated)
- Study startFeb 2007
- Primary completionMay 2009
- Study completionMay 2009
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 Diabetes MellitusStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Investigators
- Professor AN Nicholson, Principal investigator, University of SurreyDr D Kerr, Principal investigator, Royal Bournemouth HospitalDr D Coppini, Principal investigator, Poole General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370656
- Sponsor's protocol ID
- CRC 235
- Status last verified
- Nov 2009
- First submitted
- 31 Aug 2006
- Last updated
- 17 Nov 2009
- Results posted
- No
Publications
Boyle J, Eriksson ME, Gribble L, Gouni R, Johnsen S, Coppini DV, Kerr D. Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: impact on pain, polysomnographic sleep, daytime functioning, and quality of life. Diabetes Care. 2012 Dec;35(12):2451-8. doi: 10.2337/dc12-0656. Epub 2012 Sep 18.
PubMed 22991449
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Parallel Groups Investigation Into the Effects of Pregabalin, Duloxetine and Amitriptyline on Aspects of Pain, Sleep, and Next Day Performance in Patients Suffering From Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00370656
- Acronym / sponsor ID
- CRC 235
- Conditions
- Diabetes Mellitus, Peripheral Neuropathies
- Keywords
- Diabetic Peripheral Neuropathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 1 Sep 2006 (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 purpose of this study is to assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing pain in diabetic patients as assessed by Brief Pain Inventory (BPI).
Detailed description
Little is understood concerning the interaction of pain with sleep. Pain may disrupt sleep leading to daytime sleepiness and poor sleep can increase the perception of pain. There is uncertainty concerning the most effective way in which medication could be used to ease pain and poor sleep in patients such as those with diabetic peripheral neuropathy. Various drugs have been tried or proposed, and these include amitriptyline, pregabalin and duloxetine.
Amitriptyline is believed to relieve pain and improve sleep, though there is little evidence of its beneficial effects on sleep. Furthermore, even at low doses, it affects reaction time, attention, memory, information processing.
In two studies with duloxetine, it has been shown to significantly reduce pain compared with placebo, although little data are available on the usefulness of this compound in the management of pain with poor sleep.
Pregabalin has been shown to be effective in reducing pain, and therefore improving sleep. It has also been demonstrated that it has limited potential to affect daytime cognition. In another study gabapentin (a compound structurally related to pregabalin) demonstrated superior efficacy in the management of pain compared to amitriptyline.
Therefore this study will assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing pain associated with diabetes and poor sleep.
As the incidence of diabetes is predicted to increase in future years and as a consequence so will the cases of diabetic peripheral neuropathy (DPN), this research will serve to provide essential information on sleep and DPN which will be beneficial now and in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or above
- Have a diagnosis of Diabetes mellitus for at least a year
- Agree not to smoke whilst resident in the CRC
- Able to understand the patient information sheet and provide written informed consent
- Score above 12 on the LANSS
Key exclusion criteria (14 listed)
- There is evidence of an end stage disease of a major system (hepatic, renal, respiratory, haematologic (PA), immunologic, cardiovascular, inflammatory, rheumatology, active infections, peripheral vascular disease, untreated endocrine(hypothyroid)
- There is evidence of a recent ischaemic event
- There is evidence of recurrent and/or severe hypoglycemia requiring assistance in last 3 years
- Evidence of sleep pathology that would interfere with the assessment of treatment (assessed on habituation night)
- Currently receiving treatment for malignancy
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 |
|---|---|---|
| Pregabalincapsule, 150mg bd, 300mg bd | Drug | – |
| DuloxetineCapsule, 60mg on, 60mg bd | Drug | – |
| AmitriptylineCapsule. 25 mg bd, 25 mg om and 50 mg on | Drug | – |
Primary outcome
Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory.
Time frame: December 2008
1 secondary outcome
Whether there has been an improvement in sleep continuity and subjective sleep, morning after cognitive and psychomotor performance, and quality of life (QoL).
Time frame: December 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2009.
- Derived from this study: PubMed 22991449Boyle J, Eriksson ME, Gribble L, Gouni R, Johnsen S, Coppini DV, Kerr D. Randomized, placebo-controlled comparison of amitriptyline, duloxetine, and pregabalin in patients with chronic diabetic peripheral neuropathic pain: impact on pain, polysomnographic sleep, daytime functioning, and quality of life. Diabetes Care. 2012 Dec;35(12):2451-8. doi: 10.2337/dc12-0656. Epub 2012 Sep 18.
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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.
Professor AN Nicholson principal investigator
University of Surrey
Dr D Kerr principal investigator
Royal Bournemouth Hospital
Dr D Coppini principal investigator
Poole General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pregabalin, Duloxetine and Amitriptyline in people with Diabetes Mellitus and Peripheral Neuropathies, run by University of Surrey at 3 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 8 inclusion and 14 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: finished, as of the sponsor's last update on 17 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. (time frame: December 2008). 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 NCT00370656, 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 17 Nov 2009.