Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-29 @ 5:00 PM
Study NCT ID:
NCT00370656
Status:
COMPLETED
Last Update Posted:
2009-11-17
First Post:
2006-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}, {'id': 'D000639', 'term': 'Amitriptyline'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-16', 'studyFirstSubmitDate': '2006-08-31', 'studyFirstSubmitQcDate': '2006-08-31', 'lastUpdatePostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory.', 'timeFrame': 'December 2008'}], 'secondaryOutcomes': [{'measure': 'Whether there has been an improvement in sleep continuity and subjective sleep, morning after cognitive and psychomotor performance, and quality of life (QoL).', 'timeFrame': 'December 2008'}]}, 'conditionsModule': {'keywords': ['Diabetic Peripheral Neuropathy'], 'conditions': ['Diabetes Mellitus', 'Peripheral Neuropathies']}, 'referencesModule': {'references': [{'pmid': '22991449', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nAmitriptyline 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.\n\nIn 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.\n\nPregabalin 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.\n\nTherefore this study will assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing pain associated with diabetes and poor sleep.\n\nAs 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years of age or above\n2. Have a diagnosis of Diabetes mellitus for at least a year\n3. Agree not to smoke whilst resident in the CRC\n4. Able to understand the patient information sheet and provide written informed consent\n5. Score above 12 on the LANSS\n6. Have neuropathic pain of diabetic origin\n7. Score above 25 on MMSE\n8. 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.\n\nExclusion Criteria:\n\n1. 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)\n2. There is evidence of a recent ischaemic event\n3. There is evidence of recurrent and/or severe hypoglycemia requiring assistance in last 3 years\n4. Evidence of sleep pathology that would interfere with the assessment of treatment (assessed on habituation night)\n5. Currently receiving treatment for malignancy\n6. Suffer from seizures including epilepsy\n7. There is evidence of a history of dependence on or abuse of alcohol/recreational drugs\n8. Need to use a wheel chair (incompatible with studies in a sleep laboratory)\n9. Involved in a clinical trial in last 3 months\n10. Pregnant, lactating or inadequate contraception\n11. Vision inadequate for the performance tests (as assessed at screening)\n12. Colour Blind\n13. Will not co-operate with study procedures\n14. Will not give permission to inform GP'}, 'identificationModule': {'nctId': 'NCT00370656', 'briefTitle': 'Effects of Pregabalin, Duloxetine & Amitriptyline on Pain & Sleep', 'organization': {'class': 'OTHER', 'fullName': 'University of Surrey'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CRC 235'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'description': 'capsule, 150mg bd, 300mg bd'}, {'name': 'Duloxetine', 'type': 'DRUG', 'description': 'Capsule, 60mg on, 60mg bd'}, {'name': 'Amitriptyline', 'type': 'DRUG', 'description': 'Capsule. 25 mg bd, 25 mg om and 50 mg on'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BH7 7DW', 'city': 'Bournemouth', 'state': 'Dorset', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'BH15 2JB', 'city': 'Poole', 'state': 'Dorset', 'country': 'United Kingdom', 'facility': 'Poole General Hospital', 'geoPoint': {'lat': 50.71429, 'lon': -1.98458}}, {'zip': 'GU2 7XP', 'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'University of Surrey Clinical Research Centre', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'overallOfficials': [{'name': 'Professor AN Nicholson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Surrey'}, {'name': 'Dr D Kerr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Bournemouth Hospital'}, {'name': 'Dr D Coppini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poole General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Surrey', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Anthony Nicholson', 'oldOrganization': 'University of Surrey'}}}}