CTRI/2023/03/051072RecruitingPhase 2
A Prospective, Multicenter, Randomized, Open Label, Active Controlled, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Dose Combination (FDC) of Doxycycline Hyclate and Metformin Hydrochloride (10%w/w + 1%w/w) Gel in the Treatment Of Adults With Periodontitis
Dr Reddys Laboratories Limited15 sites in 1 country186 target enrollmentStarted: March 27, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 186
- Locations
- 15
- Primary Endpoint
- Mean Change in clinical attachment loss (CAL)
Study Overview
Brief Summary
This study is planned to evaluate the efficacy, and safety of fixed dose combination (FDC) of doxycycline hyclate and metformin hydrochloride (10%w/w + 1%w/w) gel in the treatment of adults with periodontitis. Male and non-pregnant female subjects (18-65 years of age) with clinical diagnosis of Stage III or stage IV periodontitis will be included in tral
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or female subjects between 18 – 65 years of age (Both inclusive), with a clinical diagnosis of Stage III or stage IV periodontitis characterized by ≥5 mm interdental clinical attachment loss (CAL) and pockets measured with probing depth (PD) ≥6 mm.
- •Subjects with ≥14 natural teeth.
- •Willing to provide written informed consent and comply with study instructions for its duration.
- •In good general health other than periodontitis according to medical history, physical examination and clinical judgment undertaken by investigator.
- •Non-alcoholics & Non-smokers / Ex-smokers (at least 2years of abstinence)
- •Able to follow written and verbal instructions, perform oral hygiene as specified in the protocol, & return to the center for specified study visits.
- •Negative serum pregnancy test prior to beginning therapy and agreement to use adequate birth control during the study for females of child-bearing potential.
Exclusion Criteria
- •Known hypersensitivity to Doxycycline Hyclate or other Tetracyclines and/or Metformin/Biguanide group or any excipients or any related drug or any substance.
- •Compromised renal function (as indicated by serum creatinine levels > 1.5 times ULN)
- •Ongoing systemic cancer chemotherapy and/or radiation therapy.
- •Known history or presence of tobacco chewing and / or betel nut usage.
- •Known history or presence of clinically significant acute or chronic illness such as Diabetes Mellitus, Neutropenia (Severe and/or acquired), Inflammatory Bowel Disease (IBD), Osteoporosis, Hyperparathyroidism, Oral candidiasis, Rheumatic fever, Cancer, Connective tissue disease (such as Systemic Lupus Erythematosus (SLE), Lichen Planus, Rheumatoid Arthritis (RA), Systemic sclerosis (scleroderma) and Ankylosing Spondylitis) etc.,
- •Presence of clinically significant cardiovascular, Hepatic, Pulmonary, Neurologic, Renal or Psychiatric disorder, or clinically significant laboratory abnormalities as judged by investigator
- •A positive hepatitis screen including positive test result for hepatitis B surface antigen and/or HCV antibodies & HIV antibody (I & II).
- •Prior/Ongoing treatment with the following medications: Mouthwash with known antibacterial properties (regularly within 1 month prior to baseline examination) ï€ Antimicrobials (6 weeks prior to baseline examination) ï€ Sulfasalazine and/or drugs causing gingival hyperplasia such as Phenytoin and other anticonvulsants (Phenobarbital, Lamotrigine, Vigabatrin, Ethosuximide, Topiramate and Primidone) or Cyclosporine or Calcium Channel Blockers (CCB) such as Nifedipine, Amlodipine, and Verapamil) (within 3 months prior to baseline examination) ï€ Systemic, topical application inside oral cavity & inhalational corticosteroids or Oral Bisphosphonates (6 months prior to baseline examination) ï€ Patients on systemic metformin therapy
- •Any need for systemic or local antibiotic prophylaxis prior to enrollment (e.g., for recent orthopedic implants, Patients with a prosthetic heart valve etc.,)
- •Ongoing pregnancy, lactation or plan of pregnancy during the proposed study period or not using an acceptable method of birth control (IUD, Norplant, Depo-Provera, Diaphragm, or Condom).
- •Enrolled in any other investigational medication study currently, or within the last 6 months.
- •Investigators opinion that subject is not suitable for the study otherwise.
- •Periodontitis disease specific exclusion criteria: a.
- •Accumulation of substantial sub-gingival calculus defined as 80% or greater surfaces of the dentition having dental calculus.
- •(Process of assessing this will be explained in separate study specific dental assessment manual) b.
- •Undergone ï€ SRP (Scaling and Root Planning) therapy (less than 6 months prior to base line examination) ï€ Surgical periodontal treatment (within past 6 months or scheduled during the study) or ï€ Orthodontic therapy including removable partial denture (ongoing or scheduled during the study) c.
- •Requirement of restorative and endodontic therapy during the study period d.
- •Periodontal sites with Class III furcation e.
- •CAL is only due to local factor.
Outcomes
Primary Outcomes
Mean Change in clinical attachment loss (CAL)
Time Frame: Day 0 and Day 90
Secondary Outcomes
- Change in New Method of Plaque Scoring (NMPS) from Baseline(Day 0, Day 28, Day 60, Day 90)
- Assessment of self-completed Oral Health Impact Profile (OHIP) ‑14 questionnaire from Baseline(Day 0 and Day 90)
- Exploratory Endpoint : Percentage change in Intra Bony Defect (IBD) / Radiographic Bone Loss (RBL)(Day 0 and Day 90)
- Mean Change in clinical attachment loss (CAL)(Day 0, Day 28, Day 60)
- Mean Change in probing depth (PD)(Day 0, Day 28, Day 60, Day 90)
- Change in Modified Papillary Bleeding Index (MPBI) from Baseline(Day 0, Day 28, Day 60, Day 90)
- Exploratory Endpoint :To evaluate release profile of Doxycycline (In GCF & In saliva) and Metformin (In GCF) with each prototype (T1 & T2) in 12 subjects in each arm to assess.(GCF and Saliva Collection will be done at pre-dose)
Investigators
Study Sites (15)
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