clinical trail (Phase III)of Fixed Dose Combination of Pregabalin and DuloxetineCapsule
- Conditions
- Health Condition 1: M792- Neuralgia and neuritis, unspecified
- Registration Number
- CTRI/2020/09/027555
- Lead Sponsor
- Torrent Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 328
1. Patients willing to give written informed consent to participate in the study
2. Male and female subjects aged 18-65 years (both inclusive)
3. Treatment naïve patients with moderate to severe neuropathic pain (e.g., post
herpetic neuralgia, diabetic neuropathy, small fiber neuropathy or idiopathic distal
sensory polyneuropathy)
4. Patient having at least moderate to severe pain intensity greater than or equal to 4 on Numeric Pain Rating
Scale (NPRS) at screening and enrollment
5. WOCBP must have negative serum pregnancy test at screening and negative urine
pregnancy test at baseline.
All female subjects will be considered to be of childbearing potential unless they are
postmenopausal. Female subjects of childbearing potential (WOCBP) are defined as
sexually mature women without prior hysterectomy, or who have had any evidence of
menses in the past 12 months. However, women who have been amenorrheic for the
past 12 or more months are still considered to be of childbearing potential, if the
amenorrhea is possibly due to other causes, including prior chemotherapy, antiestrogens,
or ovarian suppression. Postmenopausal women (defined as women who
have been amenorrheic for at least 12 consecutive months, in the appropriate age group,
without other known or suspected primary cause) or women who have been sterilized
surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral
oophorectomy with surgery at least 4 weeks prior to randomization) are not considered
WOCBP. Subjects who have undergone tubal ligation are NOT considered as surgically
sterile.
1. Patients with a history of hypersensitivity to pregabalin or duloxetine or any of its
excipients
2. Patient having history of suicidal thoughts and behavior
3. Patient having history of clinically significant medical illness in past 3 months,
such as cardiovascular disease (e.g., MI, uncontrolled hypertension, orthostatic hypotension), falls and syncope, central nervous system diseases (e.g., seizure,
bipolar disorder, depression, generalized anxiety disorder), liver disease,
angioedema, peripheral edema, angle-closure glaucoma, urinary retention,
bleeding disorder or any other disorder which may compromise safety of patient as
per investigator discretion
4. Patient having history of type I or II diabetes with glycosylated hemoglobin A1c
of greater than or eual to 10% at screening
5. Patients with clinically significant ECG abnormalities or QTc graeter than or equal to
450 msec at screening.
6. Patient having creatinine clearance less than or equal to 60 ml/min or known case of renal impairment
7. Patients with liver enzymes, ALT or AST > 3X, ALP > 2.5X of ULN (upper limit
of normal) or total bilirubin >1.5X of ULN at screening.
8. Patient having serum sodium level < 130 mmol/L at screening.
9. Patients treated with drugs that impair metabolism of serotonin (mono-amine
oxidase inhibitors, linezolide, methylene blue) or serotonergic agents other than
study drugs (SSRIs, SNRIs, triptans, antidepressants, fentanyl, lithium, tramadol,
tryptophan, buspirone, amphetamines) or corticosteroids within past 4 weeks prior
to screening.
10. Patient treated with topical or systemic pain medications (e.g., NSAIDs, local
anesthetics, methyl salicylate, capsaicin, tramadol, tapentadol etc.) within past 2
weeks prior to basel11. History of drug abuse or known active alcohol abuse within past 6 months.
Note: Use of benzodiazepines for medical reason will be allowed if the patient is
taking stable dose of the same for at least 4 weeks prior to screening.
12. Pregnant or lactating women
13. Female subjects who are of childbearing potential and who are neither surgically
sterilized nor willing to use medically acceptable contraceptive methods (sexual
abstinence, hormonal, barrier methods or intrauterine device) during the study
14. Patients participated in any other investigational drug trial within the past four
weeks prior to screeningine.
15. In the opinion of the investigator, patient is either unable to cooperate or unlikely
to adhere with any study procedures or not considered suitable candidate for
participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in Numeric Pain Rating Scale (NPRS) scoreTimepoint: from baseline to end of the treatment (week 7)
- Secondary Outcome Measures
Name Time Method