Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome

• Sponsor: Otsuka Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00233363
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Actual Duration (Months): 9.4
• Patients Per Site Per Month: 11

Study Details

Study Description

Brief Summary

The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo.

Condition or Disease	Intervention/Treatment	Phase
Xerostomia; Sjogren's Syndrome	Drug: Rebamipide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren's Syndrome
• Actual Study Start Date: Apr 15, 2005
• Actual Primary Completion Date: Jan 19, 2006
• Actual Study Completion Date: Jan 27, 2006

Outcome Measures

Primary Outcome Measures

1. Overall Improvement Rate in Dry Mouth Symptoms [Weeks 2, 4, and 8]

   At visits to the study site at two, four, and eight weeks after the start of administration, subjects self-assessed the overall change in their dry mouth symptoms in comparison with their symptoms before the start of treatment on the following four-grade scale: (1) Markedly improved (clearly better), (2) Improved (better) , (3) Unchanged (almost no difference), and (4) Aggravated (worse). The improvement rate was calculated by defining improvement as an assessment of either (1) Markedly improved or (2) Improved.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with Sjögren's syndrome (Revised Japanese criteria for Sjögren's syndrome (1999): 1998 research report on immunological intractable diseases specified by the Japanese Ministry of Health and Welfare)

2. Patients aged 20 years or older at time of consent

3. Patients with dry mouth

4. Patients with decreased salivation

Exclusion Criteria:

1. Patients who have developed dry mouth clearly due to a cause other than Sjögren's syndrome

2. Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant, etc.)

3. Patients who have received rebamipide within 3 months prior to obtaining informed consent

4. Patients who are pregnant, possibly pregnant, or lactating

5. Patients with a history of hypersensitivity to rebamipide

6. Patients who have received any other investigational drug within 3 months prior to obtaining informed consent

7. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Otsuka Pharmaceutical Co., Ltd.	Tokyo		Japan

Sponsors and Collaborators

• Otsuka Pharmaceutical Co., Ltd.

Investigators

• Study Director: Katsuhisa Saito, Division of New Product Evaluation and Development

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00233363
• Other Study ID Numbers: 037-04-001; JapicCTI-050036
• First Posted: Oct 5, 2005
• Last Update Posted: Jun 4, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Sjogren's Syndrome; Xerostomia; Syndrome; Rebamipide

Study Results

Participant Flow

Arm/Group Title	Rebamipide	Placebo
Arm/Group Description	A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.	A placebo tablet was administered orally three times a day for eight weeks.
Period Title: Overall Study
STARTED	53	51
COMPLETED	50	46
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	Rebamipide	Placebo	Total
Arm/Group Description	A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.	A placebo tablet was administered orally three times a day for eight weeks.	Total of all reporting groups
Overall Participants	50	50	100
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	33 66%	33 66%	66 66%
>=65 years	17 34%	17 34%	34 34%
Sex: Female, Male (Count of Participants)
Female	49 98%	48 96%	97 97%
Male	1 2%	2 4%	3 3%
Region of Enrollment (Count of Participants)
Japan	50 100%	50 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Overall Improvement Rate in Dry Mouth Symptoms
Description	At visits to the study site at two, four, and eight weeks after the start of administration, subjects self-assessed the overall change in their dry mouth symptoms in comparison with their symptoms before the start of treatment on the following four-grade scale: (1) Markedly improved (clearly better), (2) Improved (better) , (3) Unchanged (almost no difference), and (4) Aggravated (worse). The improvement rate was calculated by defining improvement as an assessment of either (1) Markedly improved or (2) Improved.
Time Frame	Weeks 2, 4, and 8

Outcome Measure Data

Analysis Population Description

The Efficacy Analysis Set comprised subjects in the Full Analysis Set (subjects received IMP at least once) excluding ineligible subjects and subjects with protocol deviations as described below: Subjects violating the rules on concomitant therapy Subjects with poor treatment compliance (<80% of the prescribed dose at time of treatment discontinuation/completion) Subjects with missing data on the primary endpoint at all time points

Arm/Group Title	Rebamipide	Placebo
Arm/Group Description	A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.	A placebo tablet was administered orally three times a day for eight weeks.
Measure Participants	50	50
Week 2	26.0 52%	20.0 40%
Week 4	44.0 88%	27.1 54.2%
Week 8	46.9 93.8%	39.1 78.2%

Adverse Events

Time Frame	Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks.
Adverse Event Reporting Description	Safety analysis set included all subjects who received investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.
Arm/Group Title	Rebamipide		Placebo
Arm/Group Description	A rebamipide 100 mg tablet was administered orally three times a day for eight weeks.		A placebo tablet was administered orally three times a day for eight weeks.
All Cause Mortality
	Rebamipide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/51 (0%)
Serious Adverse Events
	Rebamipide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/53 (1.9%)		1/51 (2%)
Infections and infestations
Herpes zoster	1/53 (1.9%)		0/51 (0%)
Pneumonia	0/53 (0%)		1/51 (2%)
Other (Not Including Serious) Adverse Events
	Rebamipide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/53 (58.5%)		34/51 (66.7%)
Eye disorders
Blepharitis	0/53 (0%)		1/51 (2%)
Blepharospasm	0/53 (0%)		1/51 (2%)
Conjunctivitis	0/53 (0%)		1/51 (2%)
Conjunctivitis allergic	0/53 (0%)		1/51 (2%)
Ocular hyperaemia	1/53 (1.9%)		0/51 (0%)
Gastrointestinal disorders
Abdominal pain	2/53 (3.8%)		1/51 (2%)
Abdominal pain upper	2/53 (3.8%)		3/51 (5.9%)
Aphthous stomatitis	1/53 (1.9%)		2/51 (3.9%)
Constipation	1/53 (1.9%)		2/51 (3.9%)
Diarrhoea	2/53 (3.8%)		2/51 (3.9%)
Enterocolitis	0/53 (0%)		1/51 (2%)
Gingival bleeding	1/53 (1.9%)		0/51 (0%)
Gingival pain	1/53 (1.9%)		0/51 (0%)
Glossitis	0/53 (0%)		1/51 (2%)
Nausea	2/53 (3.8%)		2/51 (3.9%)
Oral pain	1/53 (1.9%)		0/51 (0%)
Parotid gland enlargement	2/53 (3.8%)		3/51 (5.9%)
Salivary gland pain	0/53 (0%)		1/51 (2%)
Stomach discomfort	0/53 (0%)		1/51 (2%)
Stomatitis	2/53 (3.8%)		3/51 (5.9%)
Vomiting	1/53 (1.9%)		1/51 (2%)
Chapped lips	1/53 (1.9%)		0/51 (0%)
General disorders
Chest pain	1/53 (1.9%)		0/51 (0%)
Face oedema	1/53 (1.9%)		0/51 (0%)
Feeling abnormal	1/53 (1.9%)		1/51 (2%)
Malaise	2/53 (3.8%)		0/51 (0%)
Pyrexia	0/53 (0%)		1/51 (2%)
Hepatobiliary disorders
Hepatic function abnormal	1/53 (1.9%)		1/51 (2%)
Liver disorder	1/53 (1.9%)		0/51 (0%)
Infections and infestations
Furuncle	0/53 (0%)		1/51 (2%)
Herpes simplex	1/53 (1.9%)		0/51 (0%)
Herpes virus infection	1/53 (1.9%)		0/51 (0%)
Herpes zoster	0/53 (0%)		1/51 (2%)
Nasopharyngitis	2/53 (3.8%)		6/51 (11.8%)
Parotitis	1/53 (1.9%)		0/51 (0%)
Pharyngitis	2/53 (3.8%)		1/51 (2%)
Rhinitis	1/53 (1.9%)		0/51 (0%)
Tinea pedis	0/53 (0%)		2/51 (3.9%)
Injury, poisoning and procedural complications
Arthropod sting	1/53 (1.9%)		1/51 (2%)
Fracture	1/53 (1.9%)		0/51 (0%)
Muscle strain	0/53 (0%)		1/51 (2%)
Contusion	1/53 (1.9%)		0/51 (0%)
Investigations
Blood cholesterol increased	1/53 (1.9%)		0/51 (0%)
Blood creatinine increased	1/53 (1.9%)		0/51 (0%)
Platelet count decreased	1/53 (1.9%)		0/51 (0%)
Protein total increased	0/53 (0%)		1/51 (2%)
White blood cell count decreased	1/53 (1.9%)		1/51 (2%)
White blood cell count increased	1/53 (1.9%)		0/51 (0%)
Urine bilirubin increased	0/53 (0%)		1/51 (2%)
Gout	0/53 (0%)		1/51 (2%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/53 (3.8%)		5/51 (9.8%)
Back pain	1/53 (1.9%)		0/51 (0%)
Myalgia	0/53 (0%)		1/51 (2%)
Pain in extremity	1/53 (1.9%)		0/51 (0%)
Musculoskeletal stiffness	1/53 (1.9%)		0/51 (0%)
Nervous system disorders
Dizziness	2/53 (3.8%)		1/51 (2%)
Dysgeusia	0/53 (0%)		1/51 (2%)
Headache	1/53 (1.9%)		4/51 (7.8%)
Hypoaesthesia	1/53 (1.9%)		2/51 (3.9%)
Somnolence	0/53 (0%)		2/51 (3.9%)
Intercostal neuralgia	0/53 (0%)		1/51 (2%)
Reproductive system and breast disorders
Dysmenorrhoea	1/53 (1.9%)		0/51 (0%)
Metrorrhagia	2/53 (3.8%)		0/51 (0%)
Pruritus genital	0/53 (0%)		1/51 (2%)
Respiratory, thoracic and mediastinal disorders
Choking sensation	1/53 (1.9%)		0/51 (0%)
Cough	1/53 (1.9%)		1/51 (2%)
Epistaxis	0/53 (0%)		1/51 (2%)
Pharyngolaryngeal pain	1/53 (1.9%)		0/51 (0%)
Upper respiratory tract inflammation	2/53 (3.8%)		1/51 (2%)
Skin and subcutaneous tissue disorders
Eczema	0/53 (0%)		1/51 (2%)
Erythema	0/53 (0%)		1/51 (2%)
Hyperhidrosis	2/53 (3.8%)		1/51 (2%)
Prurigo	0/53 (0%)		1/51 (2%)
Purpura	1/53 (1.9%)		0/51 (0%)
Rash	2/53 (3.8%)		0/51 (0%)
Urticaria	0/53 (0%)		2/51 (3.9%)
Toxic skin eruption	0/53 (0%)		1/51 (2%)
Vascular disorders
Raynaud's phenomenon	0/53 (0%)		1/51 (2%)
Hot flush	1/53 (1.9%)		0/51 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.